Sr. Quality Engineer - Medical Manufacturing

Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 52,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.

Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high-quality solutions from ideation and market launch to volume production for medical device and pharmaceutical companies. With proven expertise in materials and technologies, Freudenberg Medical offers an extensive range of vertically integrated capabilities: precision molding and extrusions, complex catheters, hypotubes, and coatings.

• 401K Match: Save for retirement with the company's help.
• Diversity & Inclusion: We focus on providing an inclusive environment and recognize our diversity contributes to our success.
• Corporate Events: We celebrate success as a team, because only together can we achieve our goals.
• Sustainability & Social Commitment: We support social and sustainable projects and encourage employee involvement.
• Employee discounts: Opportunities for deals on products and services.

* Candidates must be legally authorized to work in the United States without current or future visa sponsorship

We offer a comprehensive benefits package that includes medical, dental, and vision coverage, retirement savings with company match and paid time-off. Additional details will be shared during the recruitment process.

Baldwin Park, CA

On-Site

Freudenberg Medical LLC

Payment The expected salary range for this position is $95,000 to $115,000 annually, depending on skills, experience, and qualifications.

• Site Subject Matter Expert on numerous ISO elements and champion site-wide standardization and continuous improvement initiatives. Has the ability to balance compliance with lean systems to support business.
• 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.
• Utilize statistical tools to support the optimization of processes.
• Create and ensure project quality planning documentation, required, sampling plan, process controls, early launch activities, monitoring activities to ensure compliance with customer project requirement.
• Lead and collaborate cross-functionally with engineering, operations, quality /regulatory affairs, customers and suppliers to address quality related issues.
• Ability to manage CAPA Review Board, provide working solutions that meets compliance and business needs & provide summary of issues to senior management.
• Lead and mentor Quality Engineers and Technicians, providing technical guidance, developing junior talent, and ensuring effective daily support for production, process improvement, and customer satisfaction.
• 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.
• Known by the site as the go to person to address the specific area.
• Ability to use current site knowledge and support other sites helping them to address their site concerns.
• Lead supplier quality activities such as supplier selection, qualification, documentation, audits, quality agreement, coordination of supplier-driven product/process changes.
• Lead internal and external audits, manage external auditors, oversee internal audit program and report on quality system compliance to site leadership with recommendation for area requiring improvements.
• Lead and collaborate cross-functionally with engineering, operations, regulatory, customers and suppliers to ensure all change related items are adequately assessed, documented and tested as required.

• 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…