Quality Engineer

ProPlate®; Anoka (MN); On-site; USD 90,000 - 125,000; Full time

Benefits offered by this job

Medical insurance

401(k) with company match

Paid time off (PTO)

Paid holidays

Flexible work schedule

Job summary

ProPlate® seeks a Quality Engineer to support new product development, manufacturing transfer, and process validation in our precision plating environment.

You will lead risk management, validation activities, and supplier qualification while collaborating with Engineering, Operations, and customers to ensure FDA and ISO compliance and drive continuous improvement.

Qualifications

• Bachelor’s degree in Engineering or related discipline.
• 5–7+ years of Quality Engineering experience in medical device manufacturing or regulated industry.
• Hands-on experience with NPD, design transfer, manufacturing transfer, and process validation.
• Strong knowledge of ISO 13485, ISO 14971, FDA 21 CFR Part 820, GMP.
• Experience with FMEA, DOE, Gauge R&R, SPC, CAPA and root-cause investigations.
• Proficiency with statistical software such as Minitab or JMP.
• Strong project management, analytical, and communication skills.

Responsibilities

• Serve as the Quality representative on cross-functional new product development teams.
• Support design transfer and manufacturing transfer activities from R&D into commercial production.
• Develop, execute, and approve validation activities including IQ/OQ/PQ protocols and reports.
• Lead risk management activities including dFMEA, pFMEA, Control Plans, Hazard Analysis, and Risk Assessments.
• Coordinate process capability studies, statistical analysis, and predictive quality initiatives.
• Support supplier qualification, incoming inspection readiness, and manufacturing process validation.
• Lead root cause investigations and CAPA activities using structured problem-solving methodologies.
• Utilize Lean and Six Sigma tools to drive continuous improvement and optimize manufacturing processes.
• Perform statistical analysis including Gauge R&R, MSA, Cp/Cpk/Ppk studies, and DOE activities.
• Participate in internal, customer, and regulatory audits while ensuring compliance with FDA and ISO requirements.
• Collaborate cross-functionally to integrate quality requirements throughout product development and manufacturing.

Skills

Quality engineering

Project management

Analytical skills

Communication skills

Problem-solving

Education

Bachelor’s degree in Engineering or related discipline

Tools

Minitab (or JMP)

Job description

ProPlate® is a leader in engineered metal coating and metallization solutions with over 40 years of expertise, serving critical industries such as medical devices, aerospace, energy, electronics, and advanced manufacturing. The company collaborates with clients from prototype development to production, creating custom plating solutions to meet unique performance and design needs. ProPlate® has pioneered cutting-edge innovations, including selective metallization of balloon catheters and radiopaque markers. Known for precision, reliability, and manufacturability, ProPlate® continues to set industry standards for high-performance components. We are seeking a Quality Engineer to support new product development, manufacturing transfer, and process validation activities within our fast-paced precision plating and surface finishing environment. Come join our great company culture!

What You’ll Do

• Serve as the Quality representative on cross-functional new product development teams
• Support design transfer and manufacturing transfer activities from R&D into commercial production
• Develop, execute, and approve validation activities including IQ/OQ/PQ protocols and reports
• Lead risk management activities including dFMEA, pFMEA, Control Plans, Hazard Analysis, and Risk Assessments
• Coordinate process capability studies, statistical analysis, and predictive quality initiatives
• Support supplier qualification, incoming inspection readiness, and manufacturing process validation
• Lead root cause investigations and CAPA activities using structured problem-solving methodologies
• Utilize Lean and Six Sigma tools to drive continuous improvement and optimize manufacturing processes
• Perform statistical analysis including Gauge R&R, MSA, Cp/Cpk/Ppk studies, and DOE activities
• Participate in internal, customer, and regulatory audits while ensuring compliance with FDA and ISO requirements
• Collaborate cross-functionally to integrate quality requirements throughout product development and manufacturing

What Makes This Role Different

• Opportunity to work on advanced medical device technologies in a highly specialized manufacturing environment
• Direct involvement in new product development, process scale-up, and commercialization activities
• Exposure to complex precision plating, metallization, and surface finishing applications
• High-impact role partnering closely with Engineering, Operations, and Customers
• Ability to influence process development, validation strategy, and continuous improvement initiatives

What We’re Looking For

• Bachelor’s degree in Engineering, Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, or related technical discipline
• 5–7+ years of Quality Engineering experience within medical device manufacturing or another regulated industry
• Hands-on experience supporting New Product Development (NPD), Design Transfer, Manufacturing Transfer, and Process Validation
• Experience executing validation activities including IQ/OQ/PQ
• Strong knowledge of ISO 13485, ISO 14971, FDA 21 CFR Part 820, GMP requirements, and related regulations
• Experience with FMEA methodologies, DOE, Gauge R&R, SPC analysis, CAPA systems, and root cause investigations
• Proficiency with statistical software such as Minitab or JMP
• Strong project management, analytical, and communication skills
• Ability to thrive in a fast-paced manufacturing environment while managing multiple priorities

Preferred Qualifications

• Experience working directly with customers in a CDMO or contract manufacturing environment
• Experience in plating, surface finishing, or advanced coatings for medical devices a plus
• Familiarity with Keyence systems, profilometers, laser measurement systems, or automated inspection technologies
• Lean Six Sigma certification or continuous improvement experience
• Certified Quality Engineer (CQE) certification preferred
• Experience with PLC programming including Rockwell/Allen-Bradley or Siemens systems
• Strong analytical and problem-solving skills
• Ability to work collaboratively in a team-oriented environment
• Competitive salary based on experience and qualifications
• Collaborative, team-oriented culture with exposure to cutting-edge medical device technologies
• Medical insurance
• 401(k) with company match
• Paid time off (PTO)
• Paid holidays
• Opportunities for professional development and career growth
• HSA or FSA
• Flexible work schedule (where applicable)