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!