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Senior Quality Engineer
hace 4 meses
Freudenberg is a global technology group that strengthens its customers and society long-term through forward-looking innovations. Together with our partners, customers and the world of science, we develop leading-edge technologies, and excellent products, solutions and services for 40 market segments. The Freudenberg Group employs some 50,000 people in 60 countries worldwide and generates sales of over 10 billion euros.
At Freudenberg Medical, we make products that save and improve the lives of people every day, all around the world. We are a global provider for medical device design and manufacturing with more than 2,000 employees. Innovation is at the core of our company, and we are proud of our industry-leading quality, lean manufacturing, and focus on innovation in products and processing technologies. Freudenberg Medical is an exciting place to work with lots of opportunity to learn, develop, and grow your career. Come join us and together we can make a difference in the future of healthcare.
**Responsibilities**:
- Responsible for the elaboration of quality inspection procedures, test methods, quality plans, inspection forms, or any other documentation required.
- Coordinate and carry out qualification and validation activities for new products, processes, test methods, changes and transfers as per FDA regulations (IQ, TMV, OQ, PQ and Quality Plans).
- Prepare and review validation protocols and reports for moderate and high complexity qualifications or participate in the approval of them.
- Prepare and review validation strategies against quality system regulation and support or lead the execution of validation plans for assigned quality projects. Participate and lead communications with the customers including weekly sustaining or NPI report out meetings, QBRs, projects meetings, other.
- Assess compliance with applicable regulations within the manufacturing processes and recommend improvements to ensure that safe and effective products are produced.
- Executes investigations for audit non-conformances, complaints and Corrective and Preventive Actions (CAPA) to correct a problem presented in the quality system or the manufacturing process.
- Responsible for the elaboration of risk management documentation such as Risk Management Plan / Report and Process FMEAs.
- Become supervisor of Quality Inspectors and/or Technicians and be responsible for the task’s assignment / coordination of this personnel in charge.
- Train Quality Assurance Inspectors and manufacturing personnel in understanding of procedures, specifications, environmental controls, etc.
**Qualifications**:
- Bachelor's Degree in Engineering, or 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) 90-100% desired.
- At least 6 years related experience and/or training working knowledge of 21CFR820 (quality systems regulation/good manufacturing practices for medical devices), ISO 13485 and 14971 standards.
- At least 2 years’ experience leading and/or supporting NPI projects
- Requires excellent organizational, communications and project management skills and the ability to work effectively in a multi-task environment. Projects manage tactical day to day activities along with higher level projects.
- Understanding and technical leadership and guidance with statistical techniques (i.e. sample size determination, DOE, Lean and Six Sigma process improvement techniques, etc.)
- Strong knowledge and understanding of quality requirements for the Medical Device Industry with general technical understanding of business operations.
- Excellent verbal, written, analytical, computer and interpersonal skills with the ability to demonstrate lead capabilities with team approach, and sound decision making.
- Assertive, Takes initiative, self-starter, energetic, motivated and self-managed.
- Positive, Respectful, and Professional attitude.
- Experience with injection molding, silicone, and coating preferred
Some of your Benefits
Health insurance: Insurance: backstop protection against health risks
Occupational safety: Safety as a top priority, in all aspects of your work
Meal allowance: Allowance makes meals more affordable
Diversity & Inclusion: Enter a diversity-driven world of innovation
Sustainability / Community service: Making a difference with sustainability, community service
Additional Information
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