Key Quality Assurance Manager
hace 1 día
Freudenberg Medical is a leading provider of medical device design and manufacturing services. As a global company, we employ over 50,000 people in 60 countries worldwide.
Our focus on innovation drives us to develop cutting-edge technologies and products that improve the lives of people around the world. We take pride in our industry-leading quality, lean manufacturing, and commitment to excellence.
As a Key Quality Assurance Manager at Freudenberg Medical, you will play a critical role in ensuring the highest standards of quality in our products and processes.
Responsibilities:
- Develop and implement quality inspection procedures, test methods, and quality plans to ensure compliance with regulatory requirements.
- Coordinate and execute qualification and validation activities for new products, processes, and test methods.
- Prepare and review validation protocols and reports for moderate and high complexity qualifications or participate in their approval.
- Develop and execute validation strategies against quality system regulation and support the execution of validation plans for assigned quality projects.
- Communicate effectively with customers, including weekly sustaining or NPI report out meetings, QBRs, and project meetings.
Qualifications:
- Bachelor's Degree in Engineering or a related science/technical field.
- American Society for Quality CQE (Certified Quality Engineer) and/or Certified Lean Six Sigma Black Belt preferred but not required.
- Certified or trained as Intern Auditor.
- Bilingual (English/Spanish) desired.
- At least 6 years of experience in a related field, working knowledge of 21CFR820 (quality systems regulation/good manufacturing practices for medical devices), ISO 13485, and 14971 standards.
- Experience leading and/or supporting NPI projects.
Benefits:
- Health insurance: backstop protection against health risks.
- Occupational safety: safety as a top priority in all aspects of your work.
- Meal allowance: makes meals more affordable.
- Diversity & Inclusion: enter a diversity-driven world of innovation.
- Sustainability/Community service: making a difference with sustainability and community service.
Additional Information:
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