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Quality Manager - Medical Devices
Beverly, MA
Job Description
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 51,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.
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 2,500 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. You support our team as Quality Manager - Medical Devices
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 2,500 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. You support our team as Quality Manager - Medical Devices
Responsibilities
- Responsible for leading, development, and management of effective and compliant quality systems and work closely with various cross functional members of site to ensure all requirements are described and meet the needs of regulations and functional excellence.
- Serve as Management Representative responsible for representing site to all regulatory bodies including registered notified bodies and ensuring management review activities are conduct per regulations.
- Manage all client quality systems audits and ensure timely response to any audit concerns.
- Participate in new product/project development to ensure quality requirements are established.
- Work directly with operating entities to ensure that management controls, product life cycle requirements including risk management, inspections, improve yield and product quality, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
- Ensure the quality activities are planned; resources allocated; priorities established and activities executed to meet goals, working within the people management systems in the Company to develop others (performance management, rewards and selection process); and Creating an energizing work environment that supports the Company's high performance culture while ensuring and efficient and flexible organization.
Qualifications
- Bachelor's degree in a relevant field.
- Minimum of 7 years of combined Quality Management, Manufacturing, and/or Product Development experience.
- At least 5 years of experience in the medical device industry.
- 5+ years of demonstrated ability in managing, coaching, and mentoring employees.
- Familiarity with ISO Quality Systems requirements, FDA GMP, and QSR.
- Proficiency in using Electronic Quality Management Systems.
- Proven experience with audits.
- Previous leadership role in Quality Assurance
Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
5+ years
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