Regulatory Affairs Specialist - 12 month FTC

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Senior Quality Engineer

UK

This is a fantasy opportunity for a Senior Quality Engineer to join a Global Medical Device company based in North Yorkshire. You will be responsible for supporting the compliance team to ensure all required certification is maintained.

Main Tasks/Responsibilities:


• Complete internal audits in compliance with ISO 13485, 21 CFR, MDD/MDR and UKCA regulations.

• Responsible for the logging, investigating, and documenting of non-conformities, ensuring appropriate action is taken to correct the issue and prevent recurrence, these must be completed within appropriate timescales including:

• Corrective and Preventative Action Reports (CAPA)

• Non-Conformity Reports (NC)

• Regulatory reporting

• Prepare trending analysis data whilst escalating any trends to a CAPA. Assist with preparation for the Quality Review Meeting.

• Assist in the implementation of compliant processes and QMS documentation across multiple sites.

• Responsible for the review and implementation of third-party agreements.

• Undertake any other duties as may be requested.


Knowledge and Qualifications:

Essential:


• Experience of working in a Quality environment, within the Medical Device Industry.

• Experience of auditing to ISO 13485, preferably at Lead Auditor level.

• Experience of generating and completing CAPA/Complaints and Root Cause Analysis.


Desirable:


• Experience/knowledge of auditing the MDR, 21 CFR and UKCA regulations.

• Experience/knowledge of reporting incidents to competent authorities.

• Experience in writing processes compliant with standards.

• Experience of ISO 14001.


Skills/Competencies:


• Excellent interpersonal skills, including the ability to work as part of a team and to work with people from across the whole company.

• Good organisation and leadership skills and attention to detail.

• Good written and verbal communication skills.

• A can-do attitude with the ability to take initiative and work to deadlines across multiple simultaneous tasks and projects

• Problem Solver



Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.

Check us out on our website and LinkedIn for more roles.

We respect your personal data and would never offer it to third parties! For more information on how we handle your data, feel free to check out the Austin Fraser Privacy Notice or contact privacy@austinfraser.com Austin Fraser International Ltd is registered in England: 14971372 Austin Fraser International Ltd, 33 Soho Square, London, W1D 3QU



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Senior Quality Engineer

UK

This is a fantastic opportunity for an experienced Senior Quality Engineer to join a Medical Device Manufacturer based in the beautiful county of Devon.

You will work closely with the Quality Manger in the development, implementation, and maintenance of company quality procedures, standards, and specifications. You will play a critical role in ensuring that these controls are robust, fully implemented, and upheld across the business. This position will also require you to lead and manage the internal audit process, acting as the primary point of contact for site-related audits.

In this role, you will collaborate with the Quality Team to foster a culture that emphasises the importance of quality and teamwork, driving collaboration throughout the buisness. By providing guidance and leadership across departments, you will work closely with Leaders on site to ensure that all products meet the highest standards of quality and reliability. Additionally, you will be responsible for reviewing and approving technical and engineering documentation, ensuring that processes are correctly followed and adhered to.

Your ability to communicate effectively with the Operations team is key, as you will collaborate on development activities and resolve any quality concerns. You will also take charge of managing customer complaints, ensuring that all procedures are followed and that documentation is accurately and promptly completed. Furthermore, you will lead problem-solving initiatives, working across departments to identify and implement improvements.

Qualifications:

To be successful in this role, you will need at least 5 years of experience in quality systems /quality engineering, with a proven background in a manufacturing environment. You must have a strong understanding of quality methodologies and techniques, as well as in-depth knowledge of ISO 13485.

Benefits

The business offers benefits such as; hybrid working (up to 2 days a week working from home), 25 days annual leave (plus bank holidays and increasing over length of service), ongoing training and development, health care plans, pension scheme, and more.

Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.

Check us out on our website and LinkedIn for more roles.

We respect your personal data and would never offer it to third parties! For more information on how we handle your data, feel free to check out the Austin Fraser Privacy Notice or contact privacy@austinfraser.com Austin Fraser International Ltd is registered in England: 14971372 Austin Fraser International Ltd, 33 Soho Square, London, W1D 3QU



Read more