Sr. Quality Engineer - Medical Manufacturing

Freudenberg Medical; Baldwin Park (CA); Sur place; USD 95 000 - 115 000; Plein temps

Avantages offerts par ce poste

401K Match

Diversity & Inclusion

Corporate Events

Sustainability & Social Commitment

Employee discounts

Résumé du poste

Freudenberg Medical LLC in Baldwin Park, CA is seeking a Sr. Quality Engineer to lead quality programs in medical manufacturing.

The role emphasizes ISO 13485 compliance, GMP, and NPI quality activities with CAPA, audits, and supplier quality coordination. The candidate will apply DOE, FMEA, SPC, MSA, control plans, and risk management to ensure product quality from design through production, mentor junior staff, and collaborate across engineering, operations, and regulatory teams.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Biology, or related field.
• 8+ years’ quality engineering experience in the medical device industry.
• Strong knowledge of GMP and ISO 13485/14001/14971.
• Experience with DOE, FMEA, Control Plan, MSA, SPC, GD&T.
• Leadership in audits and CAPA processes.
• Lean/Six Sigma certification is a plus.

Responsabilités

• Lead site-wide quality initiatives and standardization.
• Apply statistical tools to analyze data and drive improvements.
• Lead NPI quality activities and design transfer (IQ/OQ/PQ, FMEA).
• Manage CAPA Review Board and provide solutions to senior management.
• Mentor Quality Engineers and Technicians for daily support.

Connaissances

Quality engineering

GMP

CAPA

Root cause analysis

DG/T quality tools

Formation

Bachelor's degree in Engineering

Outils

Minitab

SPC

DOE

FMEA

Description du poste

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.

Benefits

• 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.

Sr. Quality Engineer - Medical Manufacturing

Responsibilities

• 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.

Qualifications

• 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.
• Preferred:
• 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

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.