We are seeking a highly skilled Quality Manager to support our early-stage medical device technology company in its development and manufacturing activities. Reporting to the COO, this role will be responsible for overseeing our quality system, internal manufacturing processes, and sub-contract manufacturing partners.
Key Responsibilities:
* Maintain and report on the performance of our Quality Management System (QMS) to Senior Management.
* Supervise Quality Technicians and Engineers, leading them in completing departmental objectives and goals.
* Ensure quality system oversight through management reviews, internal audits, and supplier control.
* Manage manufacturing validation, customer complaints, and CAPA/NCRs.
* Lead our team in external audits, including FDA and Notified Body audits.
* Provide QA support to Operations to meet their objectives.
Requirements:
* Bachelor's degree in a scientific discipline with 4 years' experience in the medical device or pharmaceutical industry.
* Strong analytical, writing, and interpersonal skills.
* Demonstrated knowledge of ISO 13485 and 21 CFR 820 requirements.
* Ability to work efficiently as part of a team and meet targets/goals.
* Excellent organizational, management, and communication skills.