A growing company in the medical device industry is seeking a Quality Manager to support its development and manufacturing activities. This role offers an exciting opportunity to join an innovative team and contribute to the advancement of medical technology.
Responsibilities:
- Maintain the Quality Management System (QMS) and report its performance to senior management.
- Supervise Quality Technicians and Quality Engineers, leading the team in achieving departmental objectives.
- Oversee quality system processes, including management reviews, quality reviews, and internal audits.
- Manage supplier quality, including audits, SCARs, performance monitoring, and quality agreements.
- Support manufacturing validation, including MVP development, PFMEAs, validation protocols, and reports.
- Handle customer complaints, approving analysis reports and reviewing complaint trends.
- Oversee CAPA and NCR investigations, ensuring timely closure.
- Manage lot release processes, including routine sterilization and product approvals.
- Lead external audits for regulatory compliance, including FDA and Notified Body quality audits.
- Provide quality assurance support to operations to meet quality, cost, and output objectives.
- Ensure cross-functional communication to maintain awareness of quality requirements.
- Update and refine the QMS to align with evolving regulatory and business needs.
Qualifications & Experience:
- Bachelor’s degree in a scientific discipline with 4+ years’ experience in the medical device or pharmaceutical industry OR a combination of relevant education and work experience and Managment expereince.
- Strong knowledge of ISO 13485 and 21 CFR 820 requirements.
- Proven ability to work effectively within a team and achieve targets efficiently.
- Excellent organizational, management, and communication skills.
- Strong interpersonal and leadership abilities to drive quality initiatives.
- Deep understanding of quality principles and their application in development and manufacturing environments.
This role is ideal for someone looking to take the next step in their quality management career within an innovative and fast-paced environment.