Quality Assurance Engineer
Description✓Quality Assurance Engineer
✓Sheffield
✓£30,000 - £40,000
✓Page 1 Recruitment is partnering with a leading surgical instrument manufacturer in the search for a Quality Assurance Engineer
✓This is an exciting opportunity to join a growing company and make a significant impact.
✓As the Quality Assurance Engineer, you will ensure compliance with ISO 13485, ASTM quality systems, and customer specifications
✓Your attention to detail and expertise will play a vital role in maintaining high standards and driving continuous improvement within the Quality Management System [QMS].
✓Key Responsibilities:
✓* Ensure compliance with ISO 13485, ASTM quality systems, and customer specifications, maintaining the highest standards of quality.
✓* Drive continuous improvement of the Quality Management System [QMS] to enhance overall product and process quality.
✓* Develop and maintain equipment and special process validations, including subcontract services, to ensure accurate and reliable operations.
✓* Evaluate and maintain software validation to ensure ongoing effectiveness and compliance with regulatory requirements.
✓* Lead quality improvement projects, proactively addressing non-conformances, and driving a culture of continuous improvement.
✓* Conduct thorough audits of supplier-provided materials to uphold quality standards and ensure adherence to specifications.
✓* Develop and implement an optimized inspection strategy to streamline quality inspection processes and maximize efficiency.
✓* Collaborate closely with blue-chip clients on special projects, effectively communicating and aligning with their quality expectations.
✓* Work alongside project leaders to develop effective solutions for quality issues, ensuring timely resolutions.
✓* Maintain all validations in accordance with customer and standard requirements, ensuring traceability and compliance.
✓Key Attributes and Skills:
✓* Strong knowledge and capability in quality management systems, including EN ISO 13485 for Medical Devices and a minimum of EN ISO 9001.
✓* Experienced auditor skilled in conducting efficient Customer, Internal, and External audits covering Company QMS and EN ISO Standards.
✓* Proven ability to drive tasks to completion and ensure timely closure.
✓* Familiarity with PPAP and Validation Compliances, including IQ, OQ, and PQ for processes and machinery.
✓* Ability to undertake the duties of a Quality Assurance Engineering Manager.
✓* Proficient in precision manufacturing and tolerancing in metals and plastics, ensuring high-quality production standards.
✓What's in it for you!
✓* Generous Basic Salary
✓* 26 Days Holiday + Bank Holidays
✓* 6% Pension Contribution
✓* Real growth opportunities
✓* Great working environment
✓Interested in this opportunity? Click "Apply Now" or contact Chengi at Page 1 Recruitment on [phone number removed] Show more →
✓Sheffield
✓£30,000 - £40,000
✓Page 1 Recruitment is partnering with a leading surgical instrument manufacturer in the search for a Quality Assurance Engineer
✓This is an exciting opportunity to join a growing company and make a significant impact.
✓As the Quality Assurance Engineer, you will ensure compliance with ISO 13485, ASTM quality systems, and customer specifications
✓Your attention to detail and expertise will play a vital role in maintaining high standards and driving continuous improvement within the Quality Management System [QMS].
✓Key Responsibilities:
✓* Ensure compliance with ISO 13485, ASTM quality systems, and customer specifications, maintaining the highest standards of quality.
✓* Drive continuous improvement of the Quality Management System [QMS] to enhance overall product and process quality.
✓* Develop and maintain equipment and special process validations, including subcontract services, to ensure accurate and reliable operations.
✓* Evaluate and maintain software validation to ensure ongoing effectiveness and compliance with regulatory requirements.
✓* Lead quality improvement projects, proactively addressing non-conformances, and driving a culture of continuous improvement.
✓* Conduct thorough audits of supplier-provided materials to uphold quality standards and ensure adherence to specifications.
✓* Develop and implement an optimized inspection strategy to streamline quality inspection processes and maximize efficiency.
✓* Collaborate closely with blue-chip clients on special projects, effectively communicating and aligning with their quality expectations.
✓* Work alongside project leaders to develop effective solutions for quality issues, ensuring timely resolutions.
✓* Maintain all validations in accordance with customer and standard requirements, ensuring traceability and compliance.
✓Key Attributes and Skills:
✓* Strong knowledge and capability in quality management systems, including EN ISO 13485 for Medical Devices and a minimum of EN ISO 9001.
✓* Experienced auditor skilled in conducting efficient Customer, Internal, and External audits covering Company QMS and EN ISO Standards.
✓* Proven ability to drive tasks to completion and ensure timely closure.
✓* Familiarity with PPAP and Validation Compliances, including IQ, OQ, and PQ for processes and machinery.
✓* Ability to undertake the duties of a Quality Assurance Engineering Manager.
✓* Proficient in precision manufacturing and tolerancing in metals and plastics, ensuring high-quality production standards.
✓What's in it for you!
✓* Generous Basic Salary
✓* 26 Days Holiday + Bank Holidays
✓* 6% Pension Contribution
✓* Real growth opportunities
✓* Great working environment
✓Interested in this opportunity? Click "Apply Now" or contact Chengi at Page 1 Recruitment on [phone number removed] Show more →