Quality Leader – Medical Devices & Compliance

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

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.