The Quality Assurance Manager is responsible for maintaining the quality system to ensure compliance with all regulatory and company standards and to contribute in enhancing product quality.
Requirements
- Knowledge of FDA, ISO 13485, EU MDR, UKCA, and GMP regulatory requirements.
- Quality engineering experience using quality tools and methodologies required.
- Experience statistical tools & methodologies preferred.
- Intermediate with Microsoft Office Suite including Word, Excel, and Outlook preferred.
Responsibilities
- Serve as the Quality liaison responsible for the compliance of the local quality system and as the primary point of contact for regulatory body interactions.
- Oversee the Quality Engineering team engaged in NPD and sustaining validation activities, ensuring that validation processes meet all necessary regulatory and procedural requirements.
- Support EU MDR Technical Documentation activities including evaluating Clinical Evaluation Reports/Post Market Surveillance Reports.
- Coordinate internal and external audits as the liaison, responding to audit findings with corrective actions to prevent recurrence.
- Manage the Corrective and Preventive Action (CAPA) system; ensure adequate root cause and corrective actions are identified and to evaluate the effectiveness of actions taken.
- Supervise the customer complaint handling process to ensure timely evaluations for potential regulatory reporting.
- Oversee the Material Review Board (MRB) process to ensure that nonconforming material is adequately evaluated for dispositions with records complying to regulatory and procedural standards.
Other
- Bachelor’s Degree in Engineering or related fields OR 7+ years of relevant Quality Assurance experience in lieu of education.
- 3+ years direct managerial/ supervisory experience.
- Strong verbal and technical writing skills in English to effectively communicate across all levels.
- Strong data analytical skills and ability to identify trends and provide recommendations to improve results.
- Effective time management and problem-solving skills.
