Quality Engineer - CAPA & Compliance Lead (Medical Devices)

BVI Medical, Inc.; England; Sur place; GBP 40 000 - 55 000; Plein temps

Résumé du poste

BVI Medical, Inc. is seeking a Quality Engineer to support QA activities across the product lifecycle, ensuring regulatory compliance, managing complaints, NCs and CAPA, and contributing to health hazard analyses.

The role involves collaborating with global teams, administering ECOs, and driving a proactive quality culture at the Bidford site, with a focus on GMP standards and ISO 13485.

Qualifications

• Bachelor’s degree in engineering, life sciences, or related field; equivalent QA experience in medical devices.
• Minimum three years in a QA role, preferably in medical devices.
• Familiarity with ISO 13485, FDA 21 CFR Part 820 and related standards.
• Hands-on NC and CAPA process experience; complaint investigations.

Responsabilités

• Coordinate and execute QA activities to ensure regulatory compliance and product quality.
• Manage customer complaints, NC investigations, and CAPA actions.
• Collaborate with CVP and global teams on reportability assessments and health hazard analyses.
• Administer ECOs to support continuous improvement at the Bidford site.
• Provide SME support to notified bodies and external audits.
• Prepare detailed reports for QRB and management reviews.

Connaissances

Quality Assurance

Root cause analysis

CAPA management

GMP compliance

Non-conformance handling

ECO administration

Collaboration with global teams

Document control

Formation

Bachelor’s degree in engineering or life sciences

Quality assurance in medical devices

Outils

Quality Management Systems (QMS)

Description du poste

BVI Medical, Inc. is seeking a Quality Engineer to support QA activities across the product lifecycle, ensuring regulatory compliance, managing complaints, NCs and CAPA, and contributing to health hazard analyses.

The role involves collaborating with global teams, administering ECOs, and driving a proactive quality culture at the Bidford site, with a focus on GMP standards and ISO 13485.