Quality Assurance Manager

Salary: £26,000 – £28,800 per year

Diamond Search Recruitment are delighted to be representing our client, a well established, successful and exciting design and manufacturing business. Recruiting for a Quality Assurance and Regulatory Affairs Manager, the successful candidate will oversee the management and progression of the QA department. As an Active member of the company management team, this role reports directly in to the MD and heads a busy department of 7 QA staff.
Working 39 hours per week, Monday to Thursday 8am – 5pm and Friday 8am – 1pm and offering very attractive remuneration plus 8% non-contributory pension, 25 days holiday (plus BH), Simply Health Medical scheme and Life insurance, this is an opportunity not to be missed.
We are seeking an experienced candidate from a medical device background, someone who has worked with ISO 13485 and successfully led a team.
Main Purpose of position
* Maintain a robust QMS, compliant with ISO13485 and FDA GMP. Communicate all changes to all personnel.
* Management of the Quality department, to assist them in doing their jobs and keep the company running smoothly.
* Ensure ongoing regulatory compliance for the business.
Main duties
* Ensure that quality system requirements are effectively established and maintained in accordance with all applicable medical device regulations, ISO9001, ISO13485, FDA GMP, other standards where applicable.
* Provide leadership, guidance and corporate-level oversight to personnel within the QA department, Engineering and Production departments on matters pertaining to QA, Compliance and regulatory affairs.
* Maintain regular lines of communication and control within the quality team to promote quality awareness, regulatory partnership, and harmonization of quality processes
* Collaborate with all departments to develop, implement, monitor, and track standardized quality training for employees
* Conduct internal audits and provide guidance regarding best practices and continuous improvement
* Promote audit readiness, prepare quality teams for audits by external bodies, including FDA, and BSI, and facilitate audits as needed
* Work with relevant department(s)/stakeholder(s) on the execution of corrective action plans, tracking and verifying that deficiencies are corrected
* Respond to and communicate all relevant regulatory body communications to upper management in a timely manner.
* Maintain expert current knowledge of ISO9001, ISO13485, FDA GMP, MDR, IVDR and other applicable foreign country regulations, legislation, best practices, and guidelines related to QA/RA, monitor changes to applicable laws and regulations, identify impact to the business, and in collaboration with other stakeholders, develop response strategies and/or a work plan/budget and complete according to deadline
* Manage key quality and regulatory affairs initiatives to drive continuous improvement
* Provide consultative guidance on QA/RA matters to, the quality team and other stakeholders of QA/RA issues
* Management of vendors in conjunction with the Materials-Engineering Manager, as needed
* Travel to group locations less than 10% of time, for audits.
* Maintain the Customer Services and Aftersales support systems
* Regular Appraisals of the team on the internal systems
* Define personal development plans and staffing strategies for the QA/RA team members.
* Provide regulatory support and guidance for the company products business.
* Agree and input to the departmental budget in conjunction with the MD.
The ideal candidate
* Bachelors degree
* Experience in the development, implementation, and maintenance of a quality management system, preferably in the context Medical device design/manufacture
* Proven experience setting up a QMS and experience of FDA and/or ISO audits
* Broad knowledge of medical device regulations (e. g. 13485, MDSAP, MDR/MDD etc.), including cybersecurity requirements.
Apply today!
Diamond Search Recruitment is acting as an Employment Agency regarding this vacancy.