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Site Quality Assurance Leader
On-siteFull-timeManufacturing Quality ManagementMedical Devices
A medical device manufacturer is seeking a site quality assurance leader to manage daily quality activities, support regulatory compliance, and drive quality improvement across the site.
Responsibilities
- Lead day-to-day site quality assurance activities and direct the quality team
- Serve as the first point of contact for manufacturing quality issues
- Act as the site management representative and coordinate external audits with regulators and notified bodies
- Support internal audits and the transition of the quality management system
- Escalate significant quality issues and promote a site-wide quality culture
- Support design and development projects, including design verification, validation, and implementation of new products and design changes
- Support product and process risk management activities
- Coordinate CAPA implementation, investigations, and corrective action plans
- Support complaint investigations, trend analysis, and escalation of critical complaints
- Provide supplier quality support
- Maintain quality standards for product safety and effectiveness
- Drive quality harmonization, best practices, improvement, and customer satisfaction across the site
Requirements
- Bachelor’s degree in engineering or a science-related field, or equivalent work experience
- At least 7 years of quality assurance experience
- At least 5 years of experience in the medical device industry
- At least 3 years of supervisory experience
- Strong analytical, quantitative, organizational, communication, technical writing, and project management skills
- Ability to make quality decisions, manage deadlines, and work effectively in a changing environment
Nice to have
- Working knowledge of hardware and software testing methodologies