Quality Supervisor
7 days ago
Responsibilities
- Implement and improve quality systems for assigned areas, ensuring compliance with the Quality Management System and customer requirements.
- Oversee the execution of quality control plans, addressing critical issues and driving improvements in team performance and product quality.
- Manage quality control processes, including tests, non-conforming materials, and deviations/OOS management.
- Ensure timely completion of quality control activities, with adequate resource planning to support production demands.
- Lead investigations into OOS results and deviations, working with teams and external parties to resolve issues and implement corrective actions (CAPA).
- Support product qualification and validation by training and involving the quality team.
- Implement and monitor control methods, gathering feedback to improve procedures.
- Communicate regulations and customer requirements to the team and other departments.
- Train and manage the team to ensure proficiency and support on quality control issues.
- Participate in audits and customer meetings, providing accurate responses.
- Take ownership of CAPA actions and ensure inspection readiness.
- Compile and report KPIs related to quality control, identifying improvements to boost performance and product quality.
- Supervise QC staff, assist in recruiting, and participate in talent development.
- Manage the departmental budget and ensure spending aligns with targets.
Requirements
- 3+ years of experience in Quality Control, Quality Assurance, or Visual Inspection, ideally in the pharmaceutical or medical device industry.
- Proven experience in leading teams, providing coaching, feedback, and managing resources.
- Familiarity with regulatory standards such as ISO 9001, ISO 13485, and FDA cGMPs.
- Understanding of technologies and control strategies for manufacturing processes in the medical device and/or pharmaceutical industries.
- Knowledge of Quality Management System processes and requirements specific to device manufacturing
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