Quality Assurance and Regulatory Affairs Engineer

Swann-Morton Limited; Sheffield; On-site; GBP 30,000 - 50,000; Full time

Job summary

An established industry player is seeking a detail-oriented Quality Assurance and Regulatory Affairs Engineer to enhance their quality management systems. In this pivotal role, you will collaborate with customers and internal teams to ensure compliance with ISO standards while driving continuous improvement initiatives. The position offers a supportive work environment with a focus on quality and compliance, making it ideal for those who are passionate about maintaining high standards in the medical device sector. Join a forward-thinking company that values precision and reliability in its products, and contribute to a culture of excellence.

Benefits

10 weeks holiday per year

Enhanced pension

Subsidised canteen

Free parking

Cycle to work scheme

Qualifications

• Experience in medical devices and compliance with ISO 13485.
• Knowledge of Quality/Environmental Management Systems.

Responsibilities

• Ensure compliance with Quality and Environmental Management Systems.
• Support audits and maintain quality documentation.
• Liaise with customers regarding quality requirements.

Skills

Microsoft Office (Word, Excel)

Quality Management Systems

ISO 13485 Compliance

Education

Degree in Engineering or related field

Job description

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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