Company Summary: A small medical device manufacturing company specializing in polymer development, is currently seeking a driven, motivated, and multi-faceted Quality Manager. This role will be located in the RTP (Research Triangle Park) area. The Quality Manager will play a critical role in overseeing the Quality team and ensuring compliance with all Quality Management System (QMS) standards.
The Quality Manager will be responsible for:
- Developing and maintaining the Quality Management System (QMS) to ensure compliance with regulatory requirements such as ISO 13485:2016 certification, FDA regulations, and other relevant standards.
- Overseeing the implementation of quality processes and procedures throughout the product lifecycle, from design and development to manufacturing and distribution.
- Conducting internal and external audits to assess compliance with QMS requirements and identifying areas for improvement.
- Coordinating with cross-functional teams to address non-conformities, deviations, and corrective actions to prevent recurrence.
- Managing documentation control processes, including document creation, review, approval, distribution, and maintenance.
- Monitoring and analyzing quality metrics and Key Performance Indicators (KPIs) to track performance and drive continuous improvement initiatives.
- Ensuring that products meet regulatory and customer requirements by overseeing product release activities, including inspection, testing, and approval.
- Investigating and resolving customer complaints, working closely with customer service, engineering, and manufacturing teams.
- Providing support during regulatory inspections and audits, ensuring timely responses to findings and implementing corrective actions as necessary.
- Developing and delivering training programs on quality-related topics to enhance the skills and knowledge of employees.
- Staying informed about changes in regulatory requirements, industry standards, and best practices in quality management, and implementing necessary updates to the QMS.
The Quality Manager should have the following qualifications:
- At least 5 years of experience in a regulated medical device manufacturing environment (ISO 13485:2016, 21 CFR Parts 810, 811 and 820)
- Strong leadership/management qualifications - at least 3 years managing direct reports
- Deep familiarity with medical device FDA regulatory submissions such as 510K, Letter to File, and MDR
- ISO 13485:2016 Auditor Certification - preferred
If you see yourself in this Quality Manager role and are interested, then please don't wait to apply.
