Senior Quality Assurance Specialist
3 weeks ago
We are a leading UK manufacturer of medical devices, proudly designing, developing, and manufacturing high-quality instruments for minimally invasive surgery.
Our success is built on our people, with over 100 staff members from our head office in Leeds.
We place great value on our relationships, collaborative work environment, and inclusive culture.
Our vision is to advance healthcare through sustainable and innovative solutions.
Job Title: Quality Assurance SpecialistKey ResponsibilitiesThe successful candidate will be responsible for daily quality assurance activities, including document and change controls, CAPA/NCR's, concessions, and customer complaints.
They will prioritize tasks to effectively contribute to departmental activities and meet planned demands.
This role will work closely with the Manufacturing, Quality Control, and Purchasing teams to ensure product release on time and to the correct standards.
Day-to-Day Activities- Manage QMS activities, including document control, change control, CAPA/NCR, concessions, and supplier control.
- Complete environmental, microbiology, and product sterilisation/validation activities according to agreed schedules.
- Prioritize workloads and throughput to meet business demands.
- Ensure correct application and completion of quality documentation.
- Release batches to meet sales demands.
- Troubleshoot and resolve quality-related internal inquiries.
- Participate in external audits as QMS SME.
- Present quality data at all levels, including management review.
- Support the maintenance and development of the QMS.
- Carry out internal audits according to agreed schedules.
- Develop and improve processes and SOPs.
- Lead on assigned projects to improve quality and regulatory compliance.
To be successful, candidates must demonstrate:
- Minimum 3 years' experience in Quality Assurance, working with international quality systems for a medical device company, including ISO 13485.
- Knowledge of EU Medical Device Regulation and international regulations.
- Effective communication and interpersonal skills.
- Strong organizational skills and attention to detail.
- Good problem-solving ability and commercial awareness.
We offer a competitive salary, benefits package, and training opportunities to support growth and development.
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