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Quality Engineer

Anoka, Minnesota · Direct Hire · Applying is free — our fee is paid by the employer.

Job Title: Quality Engineer
Department: Quality
Supervisor: Director of Quality
Payroll: Exempt

POSITION SUMMARY
The Quality Engineer is directly responsible for supporting new product development quality functions including Process Qualification Validation, and Manufacturing transfer activities to commercial production at ProPlate, a fast-paced precision plating and surface finishing Contract Manufacturing and Development Organization (CDMO) specializing in medical device applications. This role will partner cross-functionally with Engineering, Manufacturing operations, Supply Chain, and Customers to ensure products and processes meet regulatory, customer, and internal quality requirements throughout the product lifecycle.
The ideal candidate will have hands-on experience in New Product development for medical device manufacturing, Risk Analysis, Process Verification and Validation, Statistical analysis, Process capabilities and transfer of products from development into commercial manufacturing.

QUALIFICATIONS

Education:
- Bachelor’s degree in engineering, Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, or related technical discipline.

Experience:
- Minimum 5-7 years of Quality Engineering experience in medical device manufacturing or regulated industry.
- Hands-on experience supporting New Product Development (NPD), Design Transfer, Manufacturing Transfer, and Process Validation.
- Experience with validation activities including IQ/OQ/PQs
- In-depth knowledge of ISO 13485, 14971 FDA 21 CFR Part 820, and other relevant regulations and standards.
- Experience working directly with customers in a CDMO contract development manufacturing environment preferred. Experience in plating, surface finishing, or advanced coatings for medical devices is a strong plus.
Skills:
- Strong project management skills.
- Excellent problem-solving and analytical abilities.
- Strong working knowledge of FMEA methodologies, DOE, Gauge R&R / Measurement system programming, SPC analysis, CAPA systems, and root cause investigation tools.
- Proficiency with statistical software such as Minitab or JMP.
- Effective communication skills, both written and verbal, with the ability to interact with all levels of the organization.
- Attention to detail and strong organizational skills.
- Ability to thrive in a fast-paced, dynamic environment while managing multiple priorities

PREFERRED QUALIFICATIONS

Experience with new product development and introduction (NPI) processes.
Experience with software validation, Cpk and Measurement system programming and electronic quality management systems (eQMS). Experience with Laser, Keyence, Profilometer a plus.
Certification in Lean Six Sigma or similar quality improvement methodologies.
Certified Quality Engineer (CQE) or other relevant certifications.
Experience in Lean Manufacturing and continuous improvement a plus
Knowledge of cleanroom manufacturing and sterilization processes a plus.
Proficiency in PLC programming ( Rockwell automation/Allen- Bradley, Siemens) a plus.

KEY RESPONSIBILITIES

New Product Development (NPD)
- Serve as Quality representative on cross-functional new product development teams.
- Support design transfer activities from R&D into manufacturing.
- Review and approve design documentation, specifications, protocols, and engineering changes.
- Participate in Design Reviews and ensure compliance with applicable regulatory requirements.
- Ensure implementation of Design Controls and Risk Management activities in accordance with FDA and ISO 13485 requirements.
- Support Phase Gate product development activities from Proof of Concept (POC) to sustained production
Manufacturing Transfer
- Lead and support manufacturing transfer activities between sites, suppliers, and customers.
- Develop and execute transfer validation plans including IQ/OQ/PQ activities.
- Ensure manufacturing readiness through process qualification and risk mitigation activities.
- Coordinate process capability studies and validation requirements for transferred processes and predictive analytics to prevent downstream manufacturing defects and product nonconformance.
- Support supplier qualification and incoming inspection readiness for transferred products.
Risk Management & Quality Engineering
- Facilitate and maintain risk management documentation including dFMEA, pFMEA, Control Plans, Hazard Analysis, and Risk Assessments.
- Lead root cause investigations using structured problem-solving methodologies such as 8D, Fishbone, 5 Whys, and CAPA investigations.
- Drive continuous improvement initiatives using Lean and Six Sigma methodologies.
- Support nonconformance investigations, deviations, and corrective/preventive actions.

Statistical & Measurement Systems
- Perform and interpret Gauge R&R studies, Measurement System Analysis (MSA) for Keyence, Profilometer, Process Capability Studies (Cp/Cpk/Ppk), and statistical analysis.
- Develop and support measurement system programming and automated inspection systems where applicable.
- Drive Lean methodologies to reduce and optimize inspection times.
- Utilize statistical tools for process validation and process improvement activities.
- Design and analyze DOE (Design of Experiments) studies to optimize manufacturing processes and improve product quality.
Validation and Compliance
- Develop, review, and approve validation protocols and reports including IQ/OQ/PQ, TMV, and CSV support as needed.
- Ensure compliance with FDA 21 CFR Part 820, ISO 13485, 14971, GMP requirements, and customer-specific requirements.
- Participate in internal, customer, and regulatory audits.
- Support complaint investigations and post-market quality activities as needed.
- Analyze quality data and metrics to identify trends and implement proactive measures
Cross-Functional Collaboration and Quality Subject Matter Expert:
- Work closely with R&D, Operations and other key departments to ensure that quality requirements are integrated into every stage of product development and manufacturing Phase gate process.
- Provide strategic guidance to ensure that quality remains a top priority.

WORK ENVIRONMENT

This position may require occasional travel to supplier sites and other company locations.
The work environment will include exposure to manufacturing areas and production plating floor, requiring adherence to safety and hygiene standards.

COMPENSATION AND BENEFITS

Competitive salary based on experience and qualifications.

Benefits package including health insurance, retirement plans, and paid time off.

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