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Reports to: Operations/Engineering (General) Manager

Summary:

This position is responsible for managing the MMT Quality Management System (QMS) and Quality Inspection Supervisor. They are responsible for managing key QMS metrics and ensuring QMS processes are adequately defined and implemented, meeting regulatory and company requirements. They provide expertise on regulatory requirements for the business. They use information gathered from audits, corrective actions, inspection data and observations to initiate and drive continuous improvement within the QMS. They partner with Production and Business Development facilitating and supporting company growth and business objectives.

Duties/Responsibilities include but are not limited to:

  • Maintain a high level of professionalism, integrity, and leadership consistent with the organization’s values and principles and holds all direct reports accountable to the same standards.
  • Represents MMT as the Quality System Management Representative.
  • Manages key QMS processes including but not limited to Change Control and Record Management, Supplier Controls, Quality Inspection and Product Release, Product Issue Management and CAPA Process, Auditing (internal and external), Training, Quality Agreements and Customer Compliance Support, and Management Review.
  • Champions compliance to QMS and facilitates compliance with all applicable regulatory and company requirements.
  • Compiles and manages Quality System metrics and communication of results to all levels of the organization
  • Support Quality Inspection Supervisor on metrology solutions and inspection challenges.

Accountabilities:

  • Follows all Quality procedures/policies ensuring that QMS requirements are achieved in an ethical manner.
  • Maintains current knowledge of applicable regulations and standards associated with the Quality System.
  • Implements Quality System Process: Publish corporate metrics and coordinates Management Reviews.
  • Meets company goals for timely actions within QMS process including Complaint and CAPA activities.
  • Meets commitments on time, in full, and with accuracy and attention to detail.
  • Represents company in positive and appropriate manner with customers, regulators, and suppliers.
  • Actively manages performance of team members and provides timely feedback to team members regarding their performance.

Training/Education/Experience:

  • Minimum 5 years of experience in a medical device manufacturing environment with Quality experience.
  • Experience with medical device manufacturing QMS compliance.
  • 4-year Bachelor’s Degree in an appropriate discipline.
  • Experience in performance management, training, mentoring, and development of others. 400 Apollo Drive, Lino Lakes, MN Revised: 5/14/2024
  • Experienced with ISO 13485 requirements and lean manufacturing.
  • Experience with failure investigation techniques, root cause analysis, problem solving, and CAPA processes.
  • Strategic planning and implementation skills (project management skills).
  • Proficient PC skills to include Microsoft Office (Excel, Word, PowerPoint, Project) and SQL Queries. Familiar with ERP systems and data retrieval.

Competencies/Talents/Personal Attributes:

  • A thorough understanding of medical manufacturing, its environment and protocols.
  • Ability to accurately assess, develop, and retain the talent of associates, while having the courage and conviction to professionally communicate short comings and, as appropriate, move underperforming employees out of the organization.
  • Independent worker with appropriate risk management.
  • Ability to effectively implement and execute on plans.
  • Strategic and tactical development and implementation.
  • Excellent communication skills, written and verbal, in English.
mountain mfg logo

As a medical device manufacturer, we must strive for perfection, in doing so we recognize that A+ talent is needed to meet the requirement of our medical customers.

Mountain Manufacturing is a full-service sub-contract medical device component manufacturer whose core competencies include Swiss turning, 5 Axis Milling, Multi-Axis Mill-Turn capabilities and EDM capabilities.

We’re hiring full-time, 1st shift EDM Specialist/Programmer to help achieve our mission of providing our customers with superior products that exceed their expectations. This requires us to develop personnel to support customer needs from a range of production processes including high-volume production to rapid product development while using the shortest lead-time.

We are willing to pay top dollar for individuals who can think outside the box and strive for perfection beyond making a part to print.

Ideal candidates will have 5+ years’ experience in the medical device component or related tight tolerance industry with a track record of having excellent workmanship standards.

The EDM department currently includes Sinker, Wire, and Drilling work centers. Those who show potential will be trained and advanced in their careers!

JOB DESCRIPTION

Our EDM specialists perform a role that consists of a variety of tasks that are vital to the medical device component manufacturing process. It requires highly skilled hands-on machining capability and excellent planning/communication skills to ensure that the many components going through the EDM process come together in the designated timeline so that the customer due date is hit.

  • Work from CAD files, engineering drawings, sketches and or verbal instructions to perform highly diversified hands-on machining operations to specifications.
  • Create and edit complex programs using CAD/CAM systems (Esprit/MasterCam), machine controllers and conversational programming including troubleshooting.
  • Meet production rates, scrap, quality, and safety requirements, by performing multiple tasks simultaneously.
  • Use measurement and analytical skills to accurately measure in-process inspection and document results by using a wide variety of precision measuring instruments to assure high quality levels in component machining.
  • Make accurate machining adjustments to a variety of machining process to yield a conforming part.
  • Knowledge of machine shop practices, elementary mechanics, machining methods, cutting qualities of materials.
  • Ability to work to +/-.0001”
  • Interface with CNC machinists/programmers, polishers, QC Inspection, and other personnel to assist in the routing, planning, work instructions, problem solving, and expediting of components.
  • Train, guide, and monitor others as requested by the Operations Manager.
  • Keep area and equipment clean and in excellent running condition.
  • Participate in continuous improvements efforts to improve shop operations.
  • Follow systems processes for job tracking and recording.
  • Report all non-conformance conditions per company procedures.
  • Willingness to work between machining processes as needed (other duties as assigned).

EDUCATION/EXPERIENCE

  • Machinist/Machine Tool certificate, and/or a minimum 5 years of EDM experience with Mitsubishi work centers.
  • In-process inspection of parts using inspection tooling such as micrometer, caliper, gage- pins, vision systems (micro vu & optical comparator) etc.
  • Ability to run multiple machines and manage time independently.
  • Experience with or formal training in AutoCAD programming (ESPRIT / MasterCam) or equivalent experience to be proficient is preferred but will accept applicants without.
  • General knowledge of Solidworks software.
  • Proficient in mathematical concepts such as fractions, percentages, ratios, and measurement and the ability to apply them to daily activities (machining, inspection, troubleshooting etc.).
  • Implement “outside the box” process improvements.
  • Skillful understanding of inspection tools and blueprint interpretation.
  • Experience with training and managing team members is a plus.
  • Effective writing and communication skills.
  • Close attention to accuracy and detailed oriented.
  • Self-motivated with the ability to prioritize work independently and establish goals and objectives with little or no supervision.
mountain mfg logo

POSITION SUMMARY

We are growing and in need of a full-time, 1st shift Quality Control Inspector to help achieve our mission of providing our customers with superior products that exceed their expectations. This requires us to develop personnel to support customer needs from a range of production processes including high-volume production to rapid product development based on our core competencies; Milling, Mill-Turning, Swiss, and EDM services.

The ideal candidate will be highly skilled in dimensional and visual inspection techniques commonly used in manufacturing precision machined components.

Area of focus includes but is not limited to:

  • Perform In-Process Inspection (Visual and Dimensional) of tight tolerance precision components, along with the recording and analysis of inspection data.
  • NCR Leader: initiate, investigate, and complete product disposition for nonconforming material per MMT’s NCR (Nonconforming Report) procedure.
  • Other activities may include the support of statistical process control, sampling plans, parts measurement, data analysis, root cause analysis, corrective action, and other Quality System activities.

ESSENTIAL DUTIES & RESPONSIBILITIES

Perform In-Process inspection and support machinist to achieve a high-quality product.

Recognize quality issues and communicate with manufacturing staff and Lead Inspector to resolve per procedure.

NCR Leader: initiate, investigate, communicate with leadership team and complete product disposition for nonconforming material per MMT’s NCR (Nonconforming Report) procedure.

Support the Quality team with ISO 13485 compliance.

Partner with Engineers to support new product development while being processed.

Interface with ERP software, JobBOSS software, and Microsoft (Outlook, Word, Excel) regularly.

Accurately document all work performed on inspection reports and travelers.

Verify completeness and accuracy of Inspection records to ensure good documentation practices are performed.

Resolve job related issues promptly in a manner that promotes harmony and aligns with the company’s objectives and goals.

Ability to influence others to follow rules and regulations and support a clean, organized, and safe work area.

Develop and foster teamwork and a positive working environment, while reducing work area distraction and the ability to keep workforce on task.
Multitasks, prioritizes, and meets deadlines in a timely manner.

Train Manufacturing personnel in quality inspection methods and techniques.

Provide recommendations or suggestions for continuous improvement.

Other duties as determined or assigned by management.

EXPERIENCE AND EDUCATION REQUIREMENTS

5 years or more of quality inspection experience (Quality Inspection, Quality Testing, and Receipt of Materials) in the medical device industry.

Experience working in a regulated environment (GMP, ISO 13485)

Thorough knowledge of quality control standards and testing methodologies

Understand and utilize Acceptance Sampling Plans using AQL sampling and 100% inspection.

Customer focused, results-oriented and displays high energy and enthusiasm (Sense of Urgency)

Knowledge of cGMP and GDP; able to provide coaching.

Displays integrity, ethics, and trust while holding themselves and others accountable.

Effective team collaboration skills. Must exhibit willingness to work in teams, promote teamwork among other employees and communicate effectively with a variety of people.

Excellent attention to detail, including spotting product or material nonconformity.

Understanding of imperial system of measurements (English and Metric) decimals, fractions and percentages. Possess intermediate math skills: addition, subtraction, multiplication, division, weights, and measures.

Handle and use typical quality inspection equipment including microscope, vision systems (Micro Vu) video measuring system, toolmakers scope, pin gages, thread gages, drop gages, calipers, rulers, laser micrometer, CMM, and other tools or methods as deem necessary.

Knowledge of GD&T and ability to read Engineering Drawing is a must, including defining the nominal (theoretically perfect) geometry of parts and assemblies, the allowable variation in size, form, orientation, and location of individual features, and how features may vary in relation to one another such that a component is considered satisfactory per customer supplied print.

Ability to recognize and identify quality issues both visually and dimensionally.

Understanding of precision component manufacturing and processes including CNC Swiss, CNC Lathe, CNC Mill, and EDM.

Basic experience with Solid works and CAD models.

mountain mfg logo

Position Summary

We are growing and hiring a full-time, 1st shift Master Scheduler to help achieve our mission of providing our customers with superior products that exceed their expectations. This requires us to develop personnel to support customer needs from a range of production processes including high-volume production to rapid product development based on our core competencies; Milling, Mill-Turning, Swiss, and EDM services.

Planning and scheduling manufacturing operations while working with manufacturing, inventory control, and procurement personnel to ensure that materials and resources are available to meet production goals.

Creating production schedules, monitoring workflow, and analyzing production data to find ways to improve efficiency, reduce waste, and minimize costs.

Assist with monitoring and tracking employees’ time and efficiency by using the JobBOSS MRP software.  This includes training new employees, monitoring and retraining current employees, making manual adjustments as deemed necessary.

The position is full-time; on site, 40+ hours per week, Monday through Friday.

Essential Duties & Responsibilities

Coordinate with Manufacturing Supervisor to prioritize production activities and allocate resources effectively.

Create production schedules to ensure timely delivery of products.

Monitor production progress and adjust schedules as needed to accommodate changes in demand or resource availability.

Communicate with purchasing staff to understand outside supplier and vendor service lead times and how they will impact MMT’s product shipment dates.

Review Job requirements to ensure customer requirements are understood and met.

Coordinate with the Manufacturing Supervisor to plan for and successfully execute any schedule changes needed to expedite shipment dates as deemed necessary by the Operations Manager.

Provide quick responses to production issues, and exercise judgment within defined procedures and practices to determine appropriate action.

Work cross-functionally with Sales, Manufacturing, and Purchasing personnel to ensure alignment throughout all departments and that customer needs and company objectives are met.

Analyze production data to identify areas for improvement in manufacturing processes and recommend changes as necessary.

Participate in production meetings to provide scheduling insights to ensure timelines and expectations are met, and delays are communicated.

Full understanding and execution of generating reports within the JobBOSS scheduling and workstation driver modules.

Assists leadership team in identifying staffing levels needed to complete production schedules.

Maintain accurate and up-to-date records of production schedules, inventory, and supply chain information.

Owner of JobBOSS Scheduling (MRP) and Workstation Driver activities; training, monitoring, reporting.

May perform other duties as determined or assigned by management.

Experience and Education Requirements

  • 5 + years’ proven experience in production scheduling or manufacturing planning   within a subcontract manufacturing environment.
  • High level understanding of CNC manufacturing techniques, inventory management, and supply chain operations.
  • Experience with outside supplier/vendor services and how lead times can affect planning.
  • Excellent math, computer, and various software skills.
  • Detail-oriented and well organized.
  • Ability to manage time well, multi-task and work with a sense of urgency when needed.
  • ERP experience strongly desired.
  • Strong analytical and problem-solving skills, with the ability to analyze complex data and make informed decisions.
  • Experience with process optimization and efficiency improvement initiatives is a plus.
  • Ability to thrive in a fast-paced and dynamic work environment, with a proactive and results-driven attitude.

Highly Qualified Candidates Will Also Possess These Qualifications:

  • Bachelors degree in relevant field or associates degree with 3+ years of relative experience.
  • JobBOSS Scheduling (MRP) experience a plus!

 

mountain mfg logo

As a medical device manufacturer, we must strive for perfection, in doing so we recognize that A+ talent is needed to meet the requirement of our medical customers.

Mountain Manufacturing is a full-service sub-contract medical device component manufacturer whose core competencies include Swiss turning, 5 Axis Milling, Multi-Axis Mill-Turn capabilities and EDM capabilities.

We’re hiring full-time, 1st shift EDM Specialist/Programmer to help achieve our mission of providing our customers with superior products that exceed their expectations. This requires us to develop personnel to support customer needs from a range of production processes including high-volume production to rapid product development while using the shortest lead-time.

We are willing to pay top dollar for individuals who can think outside the box and strive for perfection beyond making a part to print.

Ideal candidates will have 5+ years’ experience in the medical device component or related tight tolerance industry with a track record of having excellent workmanship standards.

The EDM department currently includes Sinker, Wire, and Drilling work centers. Those who show potential will be trained and advanced in their careers!

JOB DESCRIPTION

Our EDM specialists perform a role that consists of a variety of tasks that are vital to the medical device component manufacturing process. It requires highly skilled hands-on machining capability and excellent planning/communication skills to ensure that the many components going through the EDM process come together in the designated timeline so that the customer due date is hit.

  • Work from CAD files, engineering drawings, sketches and or verbal instructions to perform highly diversified hands-on machining operations to specifications.
  • Create and edit complex programs using CAD/CAM systems (Esprit/MasterCam), machine controllers and conversational programming including troubleshooting.
  • Meet production rates, scrap, quality, and safety requirements, by performing multiple tasks simultaneously.
  • Use measurement and analytical skills to accurately measure in-process inspection and document results by using a wide variety of precision measuring instruments to assure high quality levels in component machining.
  • Make accurate machining adjustments to a variety of machining process to yield a conforming part.
  • Knowledge of machine shop practices, elementary mechanics, machining methods, cutting qualities of materials.
  • Ability to work to +/-.0001”
  • Interface with CNC machinists/programmers, polishers, QC Inspection, and other personnel to assist in the routing, planning, work instructions, problem solving, and expediting of components.
  • Train, guide, and monitor others as requested by the Operations Manager.
  • Keep area and equipment clean and in excellent running condition.
  • Participate in continuous improvements efforts to improve shop operations.
  • Follow systems processes for job tracking and recording.
  • Report all non-conformance conditions per company procedures.
  • Willingness to work between machining processes as needed (other duties as assigned).

EDUCATION/EXPERIENCE

  • Machinist/Machine Tool certificate, and/or a minimum 5 years of EDM experience with Mitsubishi work centers.
  • In-process inspection of parts using inspection tooling such as micrometer, caliper, gage- pins, vision systems (micro vu & optical comparator) etc.
  • Ability to run multiple machines and manage time independently.
  • Experience with or formal training in AutoCAD programming (ESPRIT / MasterCam) or equivalent experience to be proficient is preferred but will accept applicants without.
  • General knowledge of Solidworks software.
  • Proficient in mathematical concepts such as fractions, percentages, ratios, and measurement and the ability to apply them to daily activities (machining, inspection, troubleshooting etc.).
  • Implement “outside the box” process improvements.
  • Skillful understanding of inspection tools and blueprint interpretation.
  • Experience with training and managing team members is a plus.
  • Effective writing and communication skills.
  • Close attention to accuracy and detailed oriented.
  • Self-motivated with the ability to prioritize work independently and establish goals and objectives with little or no supervision.
mountain mfg logo

Lino Lakes, MN | Full Time | $25 – $40 per Hour.

Mountain Manufacturing is a growing Medical Device component manufacturing company located in Lino Lakes, MN. Due to our growth, we are looking to add a 2nd Shift and are in need of Lathe/Mill-Turn Machine Operators to add to our production team.

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