Staff Advanced Quality Engineer

Staff Advanced Quality Engineer

Portage MI

Join a team focused on advancing quality throughout the product development lifecycle in a regulated medical device environment. As a Staff Advanced Quality Engineer you will collaborate with engineering manufacturing and project teams to ensure products meet quality regulatory and user requirements from concept through commercialization. This role offers the opportunity to provide quality leadership across new product development design validation risk management and product launch activities.

Work Flexibility:
Hybrid: candidates must reside within commuting distance of Portage MI and be able to work onsite several days per week.

What You Will Do

• Lead quality engineering activities for new product development programs ensuring compliance with applicable quality system and regulatory requirements.
• Guide development teams through design controls risk management verification validation and product launch processes.
• Conduct and maintain risk management activities including risk assessments risk analyses and implementation of mitigation strategies throughout product development.
• Lead human factors engineering activities to support the development of safe intuitive and user-focused products.
• Plan execute and approve design validation activities to verify products meet defined user needs and intended use requirements.
• Support process validation activities and establish quality controls that enable consistent manufacturing performance and long-term product quality.
• Develop inspection methods and procedures for incoming materials in-process controls and finished products to ensure compliance with product specifications.
• Review technical deliverables investigate nonconformances and corrective actions perform root cause analysis and provide quality representation during cross-functional project reviews.

What You Will Need

Required Qualifications

• Bachelors degree in Mechanical Engineering Biomedical Engineering or related engineering discipline.
• Minimum 4 years of experience in a Quality Engineering or Technical Engineering role within a research and development or manufacturing environment.
• Experience supporting quality activities within a regulated industry environment.
• Experience supporting product development design quality design controls or new product introduction activities.

Preferred Qualifications

• Working knowledge of ISO 13485 ISO14971 Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Minimum 3 years of experience as an Advanced Quality Engineer Design Quality Engineer or equivalent role.
• Experience in the medical device pharmaceutical biotechnology or other regulated manufacturing industry.
• ASQ Certified Quality Engineer (CQE) Certified Reliability Engineer (CRE) Certified Six Sigma Black Belt (CSSBB) GD&T certification or equivalent professional certification.