Quality Manager

MPE-Inc; Sturtevant (WI); On-site; USD 90,000 - 125,000; Full time

Job summary

MPE-Inc is seeking a Quality Manager to lead the quality function at our Racine/Milwaukee area facilities. You will supervise quality technicians, drive audits, CAPA, and continuous improvement initiatives in a fast-paced medical technology environment.

Responsibilities include overseeing PPAP, internal audits, control plans, measurement with metrology tools, and collaboration with cross-functional teams to ensure regulatory and customer specifications are met. Shift: 1st with some flexibility.

Qualifications

• Bachelor’s degree in engineering or quality-related field
• Manufacturing leadership experience
• Experience with customer and FDA audits
• Experience with problem identification, resolution and prevention
• Six Sigma, ISO, and FDA experience
• Experience low-volume, high product mix fabrication

Responsibilities

• Prioritize, schedule, delegate work assignments, and directly supervise the quality technicians to ensure conformance to customer product specifications, standards and regulatory requirements.
• Communicate with customers regarding issues, requests and new product introductions.
• Host customer and regulatory audits
• Manage the material review board process, part production approval process (PPAP), first article inspection, internal audit schedule, quality team’s work hours, calibration schedule, quality control plans, and receiving inspection.
• Assist in measuring parts requiring first article, in process, and final inspection using metrology equipment as necessary.
• Oversee the review and creation of control plans on prototype builds.
• Assist in establishing and implementing quality procedures, specifications, testing procedures, and standards for raw materials for in-process and finished products.
• Process customer returns and facilitate closure of non-conformance cases with the customer.
• Communicate voice of customer plant wide.
• Develop training curriculum and train employees in quality-related practices and system requirements.
• Analyze internal and customer return/complaint data to identify corrective and preventive actions.
• Participate in cross-functional teams to support continuous improvement projects to improve levels of quality and productivity.
• Coach problem solving techniques. (5 why, fishbone, pareto, 8D method)
• Use capability study and gage reproducibility and repeatability (Gage R&R) six sigma methods to analyze process and measurement variation.
• Manages complaints, CAPA, non-conforming products per applicable ISO13485 and FDA requirements.
• Manage inputs and KPI metrics for management review process per ISO13485 and FDA requirements.
• Maintain Medical Device Files and records per ISO 13485 requirements.

Skills

Quality leadership

Audits

Regulatory compliance

Problem solving

Metrology tools

Education

Bachelor's degree in engineering or quality-related field

Tools

Romer Arm

CMM

Microview

Job description

Quality Manager

Full Time Indirect Labor Sturtevant, WI, US

7 days ago Requisition ID: 1832

At MPE we are dedicated to making a difference in the world through cutting-edge medical technology. Our mission is to be the global leader in design, engineering, and manufacturing solutions for the medical and technology industries. We are committed to creating impactful solutions that improve lives and fostering an environment where our team members can thrive, grow, and contribute to groundbreaking advancements in the medical field.

A better career for you. Creating medical technology for all.

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We are seeking a dedicated Quality Manager to join our team.

In this vital role, you will be responsible for the Quality function at our Racine manufacturing facility as well as have active ongoing projects at our corporate manufacturing and assembly facility in Milwaukee.

Essential Duties and Responsibilities:

• Prioritize, schedule, delegate work assignments, and directly supervise the quality technicians to ensure conformance to customer product specifications, standards and regulatory requirements.
• Communicate with customers regarding issues, requests and new product introductions.
• Host customer and regulatory audits
• Manage the material review board process, part production approval process (PPAP), first article inspection, internal audit schedule, quality team’s work hours, calibration schedule, quality control plans, and receiving inspection.
• Assist in measuring parts requiring first article, in process, and final inspection using a Romer Arm, Microview, CMM, or other metrology equipment as necessary.
• Oversee the review and creation of control plans on prototype builds.
• Assist in establishing and implementing quality procedures, specifications, testing procedures, and standards for raw materials for in-process and finished products.
• Process customer returns and facilitate closure of non-conformance cases with the customer.
• Communicate voice of customer plant wide.
• Develop training curriculum and train employees in quality-related practices and system requirements.
• Analyze internal and customer return/complaint data to identify corrective and preventive actions.
• Participate in cross-functional teams to support continuous improvement projects to improve levels of quality and productivity.
• Coach problem solving techniques. (5 why, fishbone, pareto, 8D method)
• Use capability study and gage reproducibility and repeatability (Gage R&R) six sigma methods to analyze process and measurement variation.
• Manages complaints, CAPA, non-conforming products per applicable ISO13485 and FDA requirements.
• Manage inputs and KPI metrics for management review process per ISO13485 and FDA requirements.
• Maintain Medical Device Files and records per ISO 13485 requirements.

If you enjoy working in a fast-paced environment where precision and teamwork matter, we’d love to hear from you!

Shift Available: 1st but some flexibility needed at times.

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Qualifications

Education:

• Bachelor’s degree in engineering or quality-related degree or an equivalent experience

Experience and Training:

• Manufacturing experience required; in a leadership role is preferred
• Experience in a customer interface role
• Experience with customer and FDA audits
• Experience in problem identification, resolution and prevention
• Six Sigma, ISO, and FDA experience preferred
• Experience low-volume, high product mix fabrication processes (Punch Press, Laser cutting, Progressive Die stamping, forming, hardware insertion, welding and metal finishing.

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Physical and Mental Demands:

• Continuous: Reading, seeing, comprehension, reasoning, measuring
• Frequent: Sitting, standing, math, close vision, communication, problem solving, delegation
• Occasional: Lifting up to 30 pounds, carrying, grasping, repetitive motion, manual dexterity
• Intermittent: Lifting up to 50 pounds, reaching, kneeling, pushing, pulling, conflict resolution

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Why Join Us?

• Mission-Driven Work: Help deliver medical products that change lives.
• Growth Opportunities: We support career development and internal promotions.
• Medical (HSA-qualified and traditional plans), dental, and vision—coverage starts the first of the month after hire.
• 401(k) with company match.
• Nine paid holidays and vacation time from day one.

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