Quality Assurance Manager
Key Responsibilities:
* Maintain the company's Quality Management System (QMS) and report on its performance to senior management.
* Supervise quality technicians and engineers, leading them in completing required departmental activities.
* Oversight of quality systems, including management reviews, quality reviews, and internal audits.
* Supplier control, including supplier audits, SCARs, performance monitoring, and quality agreements.
* Manufacturing validation, including MVP development, PFMEAs, validation protocols, and reports.
* Customer complaints, including approval of analysis reports and analysis of complaint trends.
* CAPA/NCR oversight, including investigation and timely closure of CAPAs and NCRs.
* Lot release, routine sterilization, and lot release.
* External audits, leading the company through regulatory agency quality management system audits.
* Operations support, providing effective QA support to meet objectives of quality, cost, and output.
Requirements:
* Bachelor's degree in a scientific discipline with 4 years' experience in the medical device or pharmaceutical industry.
* Demonstrated knowledge of ISO and 21 CFR requirements.
* Strong analytical, writing, and interpersonal relationship skills.
* Ability to work as part of a team and meet targets efficiently.
* Organizational, management, and communication skills.
* Good interpersonal and communication skills.