Senior QA Officer

SRG are currently recruiting for a Senior QA Officer for a Medical Device Client based in the Midlands. Salary on offer is up to 45,000 plus benefits.

The role will be responsible for supporting the Quality Management System within the business ensuring compliance to ISO 13485 and FDA standards. The key purpose of the role will be to work closely with the Quality Assurance Manager and Quality Assurance department to develop and deliver a range of proactive and responsive QMS initiatives.

2. Organisational responsibilities

This role will report directly in to the Quality Assurance Manager.

Key tasks and responsibilities

  • Ensure compliance to all applicable standards, regulations and internal procedures by proactively interpreting quality and regulatory requirements and devising and implementing solutions

  • Develop and implement quality related projects

  • Prepare quality documentation by collecting, analysing and summarising information and trends including audit findings, non-conformances, customer complaints, corrective and preventive actions

  • Manage internal audit process and perform internal audits, along with management and implementation of corrective actions

  • Audit key suppliers as part of the supplier evaluation and review process

  • Work with an electronic document control system, contributing to the drafting of documentation, approval, reviewing and implementation of internal QMS documentation in accordance with ISO13485, FDA CFR 820 part 21 and MDD

  • Provide training relating to the quality management system to all levels of staff within the business

  • Support change control and new product development by providing Quality Assurance expertise to ensure quality management system requirements are achieved

  • Investigate and manage customer complaints

  • Co-coordinate and investigate non-conformances as part of the CAPA system. This will include working with the Operations team and other internal departments to manage and implement corrective and preventive actions within appropriate timescales

  • Work within the Quality department to promote continuous improvement and ensure compliance with quality policies across the business

3. Compliance responsibilities

  • Deputise for the Quality Assurance Manager

  • Act as a Lead Auditor

  • In the absence of the Quality Assurance Manager maybe called upon to act as the management representative

4. Key skills / abilities

  • Significant Quality Assurance experience including the management and investigation of customer complaints and CAPA's

  • Demonstrable experience of managing both internal and supplier audit programmes

  • A demonstrable strong working knowledge and experience of applying ISO 13485, FDA 820 part 21 and MDD standards and regulations within the Medical Device or IVD industries is essential

  • Clean room and GMP knowledge / experience

  • Writing validation protocols and validation reports with associated understanding of statistical techniques

  • Able to influence people both internally and externally to achieve objectives

  • Able to work with minimum supervision and as part of a team

  • Strong communication skills both verbal and written, flexible attitude and capable of working under pressure to tight and constantly changing deadlines

If you feel you have the right skills and experience for this role please apply online or call 0161 868 2233 and speak to Feroze Malik.

You can also send your CV

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.