Our client, an early-stage company developing innovative medical device technology, seeks a Quality Manager to support its development and manufacturing activities.
Key Responsibilities:
* Maintain the company's Quality Management System (QMS) and report on its performance to the Senior Management Team.
* Supervise Quality Technicians and Quality Engineers, ensuring completion of required departmental activities, including objectives and goals.
* Lead quality personnel in the oversight of quality systems, including management reviews, quality audits, and internal audit programs.
* Ensure supplier control through audits, SCARs, performance monitoring, and quality agreements.
* Oversee manufacturing validation, including MVP development, PFMEAs, validation protocols, and reports.
* Address customer complaints by approving analysis reports and analyzing complaint trends.
* CAPA/NCR: oversee investigations and ensure timely closure of CAPAs and NCRs.
* Lot release: manage routine sterilization and lot release processes.
* External audits: lead the company in regulatory agency quality management system audits, including FDA and Notified Body operations.
* Provide effective QA support to Operations, ensuring quality, cost, and output objectives are met.
Requirements:
* Bachelor's degree in a scientific discipline, with 4 years of experience in the medical device or pharmaceutical industry.
* Strong analytical skills, exceptional writing and interpersonal relationship skills, or relevant work experience and education combination.
* Demonstrated knowledge of ISO 13485 and 21 CFR 820 requirements.
* Able to work as part of a team, meeting targets and goals efficiently.
* Proven organizational, management, and communication skills.
* Good interpersonal and communication skills essential.
* Strong knowledge of quality principles, applying them in development and manufacturing environments.