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Quality Assurance Specialist

Quality Assurance Specialist

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Posted 2 days ago, valid for 8 days

Nottingham, Nottinghamshire NG9 4AZ

Full Time

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Sonic Summary

A regenerative medicine company focused on Orthobiologics is seeking a Quality Assurance Specialist for a 9-12 month fixed-term contract.
The position offers both part-time and full-time options, with a salary of £35,000 to £45,000 per year based on experience.
Candidates must have a degree in life sciences or a related field, along with experience working in the medical sector, particularly with ISO 13485:2016 standards.
Key responsibilities include maintaining the Quality Management System, overseeing document control, and supporting audits and regulatory inspections.
The ideal candidate will possess strong communication skills, a proactive attitude, and the ability to work independently in a fast-paced environment.

This regenerative medicine company focused on Orthobiologics are looking for a Quality Assurance Specialist for a 9-12 month FTC. Both part time and full time applications will be considered.This medical device company are seeking a talented and motivated individual to support the Quality Assurance & Regulatory Affairs (QARA) function.Reporting to the QARA & Clinical Director, this role is crucial in maintaining and improving the Quality Management System (QMS) in line with ISO 13485:2016 and 21 CFR Part 820 requirements while fostering a compliance-focused culture.The Quality Assurance Specialist will support the QARA & Clinical Director in ensuring compliance and continuous improvement of the Quality Management System (QMS). They will act as the lead document controller, ensuring that all documentation is properly created, reviewed, approved, and updated in accordance with company Standard Operating Procedures (SOPs).Key Responsibilities:

Maintain and update QMS databases, including Document Register, Non-Conformances, CAPAs, Change Controls, Training, and Standards.
Chair Change Control Committee meetings and oversee the progress of change controls.
Oversee supplier review, approval, and monitoring to ensure material and service quality.
Ensure effective handling of non-conformances, CAPAs, feedback, and complaints.
Support third-party audits and regulatory inspections.
Implement new Policies
Conduct internal audits in line with the internal audit programme.

Required Skills & Qualifications:

Degree in a life sciences or related discipline, or equivalent experience.
Experience in a medical sector working within ISO 13485:2016 is essential (experience with 21 CFR Part 820 is an advantage).
Prior experience conducting internal audits within a QMS environment (preferred).
A proactive, can-do attitude with the ability to meet ambitious goals.
High levels of integrity, able to work independently with minimal supervision.
Strong communication skills, comfortable working within a small, flexible, and fast-paced team.

This is a great opportunity to work within an innovative and growing company as part of a supportive and collaborative team, with flexible hours and the potential for remote working.

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