Senior Quality Engineer

Job Title:           Senior Quality Engineer   

Responsible to:         Quality Manager

Our client is looking for a well rounded Senior Quality Engineer to join a well respected medical device company.

Key Responsibilities

Responsible for review and acceptance procedure of protocols and reports into QDT document control system.

Responsible for QA review of Specifications and Technical drawings required by the supply chain for manufacture of the SC+.Technical authoring of QA documents, i.e. Quality Agreements. Raising problem reports, Non Conformity reports, Corrective Action and Preventative Actions to address product quality concerns and/or QMS concerns. Lead problem resolution sessions i.e. “8D”, “SY” to determine root cause(s) and to assess effectiveness of solutions.

Other responsibilities include:

• Primary point -of contact for all Quality Assurance  activities relating to manufacture.
• Deputy for Quality Manager
• Support, Mentor and develop Quality Engineers, Technicians and Analysts
• All activities generally undertaken by a QA dept. operating within medical device manufacturing, including but notlimited to;
• Leading Internal and Supplier Audits New supplier approval process Supplier corrective action requests and Complaints
• Change management Analysis and trending of data Capability studies

Development of Quality specialism i.e.

• Sterilisation
• Material characterisation Change Management Complaints

Requirements/Qualifications

• Educated to degree level in a related Engineering / Science discipline Previous experience of leading internal and external audits
• A minimum of 5 years’ experience of working within Medical devices
• Transferable IT skills including eQMS
• Willingness and flexibility to attend supplier sites, possibly for extended periods (UK & international)
• Experience in medical device process V&V oO. Key processes:
• Injection moulding
• PCBA
• CrimpingESD control 
• Packaging=  Sterilisation
• Material characterisation
• Control of clean rooms for manufacture.

Please email Benn.Neal@arm.co.uk or call me on 02392458149.