Sr. Quality Engineer - Medical Manufacturing

Freudenberg • Baldwin Park, CA

8d

About The Position

This role serves as the Site Subject Matter Expert on numerous ISO elements and champions site-wide standardization and continuous improvement initiatives. The position requires the ability to balance compliance with lean systems to support business objectives. The Sr. Quality Engineer will apply statistical tools to analyze data, make acceptance decisions, improve process capability, and support lean manufacturing and risk reduction initiatives. They will also create and ensure quality planning documentation, sampling plans, process controls, and early launch activities to meet customer project requirements. This role involves cross-functional collaboration with various departments, customers, and suppliers to resolve quality issues, manage the CAPA Review Board, and provide summaries to senior management. Additionally, the Sr. Quality Engineer will lead and mentor Quality Engineers and Technicians, guide New Product Introduction (NPI) Quality Activities and design transfer, and lead supplier quality activities. The individual will be the go-to person for specific areas and support other sites. They will also lead internal and external audits and ensure quality system compliance.

Requirements

• Bachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field.
• 8+ years’ quality engineering experience in the medical device industry.
• Understanding of statistical methods, process control, and the use of quality tools such as Design of Experiments (DOE), Failure Mode and Effects Analysis (FMEA), Control Plan, MSA, SPC, as well as GD&T and fixturing.
• Demonstrated experience with formal problem-solving methodologies, critical thinking, and deductive skills.
• Advanced understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971.
• Extensive knowledge of GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements (i.e., 21 CFR 820 in the United States, MDSAP).
• Demonstrated ability to lead internal and external audits and inspections effectively, including leading preparations and addressing findings.
• Expertise in conducting thorough root cause analyses for complex quality issues and developing effective CAPAs.
• Experience with design control processes to ensure that design/development, validation, and verification processes align with intended use and performance criteria.

Nice To Haves

• 5+ years’ experience in injection molding manufacturing operations or equivalent.
• Project management experience.
• Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) and/or Regulatory Assurance Certification (RAC).
• Lean/Six Sigma certification.

Responsibilities

• Serve as Site Subject Matter Expert on numerous ISO elements.
• Champion site-wide standardization and continuous improvement initiatives.
• Apply statistical tools (Minitab, Six Sigma, SPC, DOE) to analyze data, make acceptance decisions, improve process capability, and support lean manufacturing and risk reduction initiatives.
• Create and ensure project quality planning documentation, required sampling plans, process controls, and early launch activities.
• Lead and collaborate cross-functionally with engineering, operations, quality/regulatory affairs, customers, and suppliers to address quality-related issues.
• Manage the CAPA Review Board, provide working solutions that meet compliance and business needs, and present issue summaries to senior management.
• Lead and mentor Quality Engineers and Technicians, providing technical guidance and developing junior talent.
• Lead New Product Introduction (NPI) Quality Activities and design transfer activities, including design verification, process validation (IQ/OQ/PQ), risk management (FMEA), and compliance with regulatory standards.
• Act as the go-to person for specific areas and support other sites with their concerns.
• Lead supplier quality activities such as supplier selection, qualification, documentation, audits, quality agreements, and coordination of supplier-driven product/process changes.
• Lead internal and external audits, manage external auditors, oversee the internal audit program, and report on quality system compliance with recommendations for improvement.
• Lead and collaborate cross-functionally to ensure all change-related items are adequately assessed, documented, and tested.

Benefits

• The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior