Job Title: Quality Manager

Location: Plymouth

Our client, a leading medical device company, is seeking a dynamic and experienced Quality Manager to join their team. As the Quality Manager, you will play a vital role in ensuring the delivery of the Quality Strategy and driving continuous improvements.

If you are passionate about quality and have a strong background in the medical device industry, we want to hear from you!

Responsibilities:

Provide leadership to the site quality function, including quality systems, quality engineering, and QC analytical and Microbiology.
Manage the successful delivery of the Quality Strategy to achieve corporate goals and objectives.
Ensure compliance with MDSAP regulations, and the Medical Device regulation (MDR).
Prepare and manage the budget for the site quality function.
Ensure effective delivery of new product development by overseeing quality deliverables and compliance with design control and validation requirements.
Make decisions related to quality issues, conduct root cause analysis, and implement corrective actions to avoid product recalls.
Review and approve supplier and customer quality agreements to meet compliance and operational requirements.Requirements:

Bachelor's degree or equivalent in a scientific discipline or 4+ years of experience in the medical device or pharmaceutical industries.
Demonstrated leadership experience in previous roles.
Proficient knowledge of applicable Quality System Regulations and ISO quality requirements.
Familiarity with the Medical Device regulation.
Strong knowledge of QA, Manufacturing, Validation, Change Control, and Design Control processes.
Proficiency in spreadsheets and word processor applications.
Solid understanding of statistical methods, sampling plans, and statistical analysis.
Experience with analytical methods, equipment, process, software, cleaning, and/or facility/utility validations.

If you're interested to know more, please get in touch