Quality Engineer I

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.

Some of your 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.

Sustainability & Social Commitment: We support social and sustainable projects and encourage employee involvement.

Safe Environment: We strive to ensure safety remains a top priority, and provide a stable environment for our employees.

Personal Development: We offer a variety of trainings to ensure you can develop in your career.

*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

payments The expected salary range for this position is $70,000 to $80,000 annually, depending on skills, experience, and qualifications

You support our team as

Quality Engineer I

Responsibilities

• Understand quality system requirements to support the development, qualification and manufacturing of products to meet internal and external requirements.
• Utilize statistical analysis tools to support project team.
• Support creation of Master Validation Plan, validation protocols and reports (IQ/OQ/PQ), quality design reviews deliverables, risk management plan, and all quality related documentation.
• Assist in and may lead supporting nonconformances, complaints, CAPAs, etc. to resolve quality issues.
• Support internal and external audits, ensuring quality system compliance.
• Support Measurement System Analysis (MSA), including Gage R&R, test method validations.
  
  

Qualifications

• Bachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field.
• 0-3 years’ experience in Medical Device or a related regulated industry.
• Knowledge 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.
• Understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971. 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).
• Familiarity with design control processes to ensure that design/development, validation, and verification processes align with intended use and performance criteria.
  
  

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.