Quality and Regulatory Manager, Medical Device
Location: Charlotte, NC
Voted one of the Nation's Best and Brightest Companies to Work for, this company is a global leader in specialty Chemical, Fiber and Resin production. With top-of-the-line research and production facilities and a vast network of supply from around the world, they lead the industry in specialty Dental, Fiber, Resin, and Elastomer products. They operate in 28 countries and employees more than 10,000 employees, including over 750 in the United States. They offer a competitive compensation package that includes base pay and an annual incentive. This program is designed to reward individual performance and align overall rewards with corporate and team performance. Their employees enjoy an attractive healthcare benefits package, including wellness reimbursements to promote a healthy lifestyle. They also provide an Educational Reimbursement Plan, helping our employees fulfill their career goals, as well as a competitive 401(k).
We are looking for a highly motivated and experienced leader to drive our regulatory and quality programs in our newly expanded Industrial and Medical facility. A key focus of this position will be to provide guidance on regulatory and quality strategies to ensure compliance with US and international requirements. Working with a high-performing, results-oriented team, implement these strategies and policies to enable continual improvement in a rapidly growing business.
The position will be responsible for the overall direction and guidance of the plant’s Quality Systems and lead the Company’s initiative to operate in compliance with all local, state, federal and international regulatory requirements, with an emphasis on medical device markets. This includes the Quality Manager role for ISO certifications and management of all customer complaints. This role reports to the Business Leader and works collaboratively with a high performing, results-oriented peer group. Broadly, this person oversees all aspects of the Quality Management and Regulatory Compliance Systems.
• Utilize your comprehensive knowledge of standards, related disciplines, company strategy and goals, to ensure the highest quality product delivery
• Manage the Quality Management (QM) system management and maintenance (ISO 9001 standards)
• Support the creation, implementation, and maintenance of policies and procedures
• Ensure full compliance with all regulatory FDA, ISO, Medicare, requirements and policies: including ISO 9001, 13485, 10993, CFR 820/FDA, and MDD/93/42
• Lead the team in defining, developing and implementing quality best practices and test strategies, including the selection of testing tools, technologies, and platforms
• Respond and resolve customer inquiries or complains
• Develop and track key metrics for quality and team performance, drive their improvement over time, and communicate their status
• Travel to support above activities, including international (15% of the time.)
• BA/BS + 8 years of relevant experience with at least 5 years of quality experience in medical device-related manufacturing
• Documented audit and compliance experience of ISO 9001, 13485, 10993, CFR 820/FDA, and MDD/93/42
• Experience working with regulatory agencies and competent authorities
• Process validation experience with demonstrated track record of interpretation of ISO and FDA/MDD requirements applicable to manufacturing operations
• Strong understanding of engineering and quality practices & methods
• Excellent communication skills and attention to detail
• Highly developed problem solving and strong analytical skills
You have (even better):
• BS in Engineering (Mechanical Engineering, Chemical Engineering, Biomedical or related) + 10 years of relevant experience
• Experience with medical device product development life cycle, including risk management and design/ process verification & validation
• Japanese language fluency is desirable
All Candidates must be able to provide work related references.
If you're a candidate and would like to submit your confidential resume, please use firstname.lastname@example.org. We will contact you if your qualifications match any of our current job searches.