Quality Manager
Location: RTP
Working Situation: On-site
A Medical Device organization is seeking a Quality Manager with a specialization in Medical Devices/Combination Products to oversee all aspects of quality management throughout the product lifecycle. The ideal candidate will possess comprehensive knowledge of GMP, CFR Part 211, MDR and FDA regulations. The role requires strong leadership skills to ensure compliance with quality standards, manage supplier quality, review batch records, and drive continuous improvement initiatives.
The Quality Manager will have the following responsibilities...
- Develop and implement quality management systems for Medical Devices/Combination Products in accordance with regulatory requirements such as GMP and CFR Part 211.
- Lead and mentor a team of quality professionals to ensure adherence to quality standards and compliance with regulatory guidelines.
- Establish and maintain strong relationships with suppliers to ensure the quality and reliability of materials and components used in product manufacturing.
- Conduct thorough reviews of batch records to ensure accuracy, completeness, and compliance with established procedures.
- Collaborate with cross-functional teams including R&D, Manufacturing, and Regulatory Affairs to support product development and commercialization activities.
- Perform risk assessments and develop mitigation strategies to address quality-related issues throughout the product lifecycle.
- Lead internal and external audits to assess compliance with quality standards and regulatory requirements.
- Drive continuous improvement initiatives to enhance quality processes, reduce defects, and optimize efficiency.
- Provide guidance and support during regulatory inspections and interactions with regulatory agencies.
- Stay informed about industry trends, regulatory updates, and best practices related to quality management in the medical device industry.
The Quality Manager should have the following qualifications...
- Bachelor's degree in Engineering, Life Sciences, or related field; advanced degree preferred.
- Minimum of 10 years of experience in quality management within the medical device industry, with a focus on combination products.
- Proven leadership skills with the ability to effectively manage a team and drive results in a fast-paced environment.
- Experience managing supplier quality and conducting supplier audits.
- Excellent analytical and problem-solving skills with a keen attention to detail.
- Effective communication skills with the ability to collaborate across functional teams and communicate with regulatory agencies.
Benefits:
- Competitive Salary and PTO package
- Medical, Dental and Vision Insurance
- Tuition Reimbursement
If you are interested in the Quality Manager, please don't hesitate to apply!
