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Quality and Regulatory Site Leader - Medical Devices in Bedfordshire

Quality and Regulatory Site Leader – Medical Devices

Global Healthcare company is seeking a QA / RA professional to join their team as Site Leader.

Role:

Leading site quality activities and site quality team in accordance with company policy and procedures, ensuring effective communication within the team.

Lead the actions and continuous improvement activities of the team in meeting customer quality requirements which will include the maintenance of Quality Assurance systems across two sites.

Internal and external audits to ISO9001 / ISO13485 standards.

Lead and drive the Quality System to ensure closure of Customer Complaints, Internal Non-conformances and Supplier non-conformance, identifying root cause to prevent recurrence.

Facilitate reporting and actions on internal and external customer complaints.

Ensuring incoming goods are conforming to specification.

Ensure key raw material specifications are aligned to customer specifications.

Ensure all bio-burden and pest controls are compliant to standard.

Site representative for second and third party audits.

Supporting the development of new product & generation of technical tiles for new and existing product.

Candidate:

Degree qualified or equivalent in science, manufacturing and/or chemical engineering.

Certification as an Auditor in the area of ISO9001 / ISO13485 and/or other global quality standards.

Previous Quality Assurance Supervision / Manager experience in a Medical Device manufacturing.

More than 5 years’ experience in the manufacture of medical devices.

Medical device knowledge of CE, FDA and GMP.

Risk Management in the area of ISO 14971.

Experience of EU product submissions, license renewals, and periodic updates and registrations to regulatory agencies (FDA and EU regulatory entities) for medical devices.

Technical file compilation.

Desirable:

Lead Auditor Qualified.

Lean / 6 Sigma Qualified.

GLP (21 CFR Part 58).

Bioburden, Biocompatibility, and Microbiological Testing.

FDA 510K Submissions.

Product Recall Experience.

Knowledge of the manufacture of bonding and adhesive components.

 

Reference

SH-QARAMD

Location

Bedfordshire
Bedfordshire

Salary

£35,000 to £50,000
£35 to 45k

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