Quality Assurance and Regulatory Affairs Engineer
Quality Assurance and Regulatory Affairs Engineer
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Company Description
At Swann-Morton we are a world leader in the manufacture of surgical blades, scalpels and handles. It is a name respected globally for quality, precision, consistency and reliability and recognised for combining traditional blade making skills with the latest technology. We want our employees to embody our ethos and values that we have lived by since 1932, then, now and always.
Role Description
As Quality Assurance and Regulatory Affairs Engineer, you’ll work closely with customers and internal teams to ensure our Quality and Environmental Management Systems are fully compliant and continuously improving. You’ll support audits, maintain accurate quality documentation, and help drive a culture of quality across the organisation. If you're detail-oriented, customer-focused, and passionate about quality and compliance, we’d love to hear from you!
•Liaise with customers on any matter related to quality and in assessing their requirements
•Liaising directly with customers and answering any queries that they may have.
•Completion and distribution of documents requested by customers.
•Liaise with production on matters affecting the Quality/Environmental Management Systems
•Assist the QA/RA Systems Manager in approving Quality/Environmental Management System documentation
•Assist the QA/RA Systems Manager in ensuring that the Quality/Environmental Management System policies, procedures and instructions are documented, implemented and maintained as required
•Assist the QA/RA Systems Manager in ensuring that internal and external audits are conducted in a timely manner and corrective actions are implemented where necessary.
•Adhere to QMS job description where applicable.
•To ensure that all quality records are accurately maintained and kept.
•Assist in general administration office tasks where required.
•Adhere to Health and Safety standards.
•Any other reasonable management request.
Experience
·Experience working in a medical devices background in compliance with ISO 13485.
·Experience working with Quality/Environmental Management Systems.
Skills
·Proficient in the use of Microsoft Office applications specifically word and excel.
Working Hours
35 hours per week with early finish on a Friday
Monday to Wednesday 8.00am – 4.30pm
Thursday 8.00am – 3.30pm
Friday 8.00am – 12.00pm
10 weeks holiday per year
Enhanced pension
Subsidised canteen
Free parking provided by the company
Cycle to work scheme
Please note that the role is a fully on-site role.
Seniority level
* Seniority level
Entry level
Employment type
* Employment type
Full-time
Job function
* Job function
Engineering and Information Technology
* Industries
Medical Equipment Manufacturing
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