Lead Quality Engineer – Gloucestershire

We have an exciting opportunity available as a Lead Quality Engineer for an innovative and growing Medical Device company based in Gloucestershire. This is a fantastic role for someone looking to further develop experience in Quality focussing on quality assurance requirements and quality engineering support.

Responsibilities

• Support the application and implementation of relevant quality standards and regulations across the company (in particular FDA, ISO and MDR).
• Evaluate the manufacturing and quality activities for compliance to relevant standards and regulations. Design, manage and implement complex process solutions in order to improve workflow or compliance. Support and/or lead changes through the QMS change control system.
• Work with and influence key stakeholders to develop and maintain procedures and compliant documentation. Identify opportunities for training and develop and lead this training.
• Lead meetings and communication with colleagues to ensure the proper functioning of the Quality Management System. Adapt your approach and leadership behaviour depending on individual situations.
• Support company initiatives to support the quality management systems and other regulatory requirements
• Monitor departmental metrics including time trending and reporting, ensure quality KPIs and targets are met. Support others with QA data analysis, trending and reporting.
• Manage non-conformance and corrective & preventative action processes as directed.  Conduct and/or support data capture and root cause investigations, review actions for comprehensiveness, determine stock disposition, analyse the data for the reasons of quality improvement and reporting. Provide support and training to ensure adherence with company Standard Operating Procedures and Global Objectives for timeliness.
• Actively participate in Management Review, change control and compliance meetings as required.
• Lead and/or support Internal Audit program, ensuring schedule adherence and auditing
• Be proficient as a lead representative for presenting QA Systems to internal and external auditors. Support external audits as required.
• Support timely product complaint investigations: investigate root cause, evaluate risks and determine appropriate corrective and/or preventative actions. Support the analysis of data for Quality Improvement and reporting.
• Adhere to Quality Management System (QMS) requirements in line with company’s Good Manufacturing Practice (GMP) and Good Documentation Practice (GDocP) as per ISO13485 & FDA21 CFR Part 820.
• Act as delegate for Quality Manager when required
• Champion change management and lead continuous improvement.
• Supervise and mentor team members, provide support and coaching for both technical and soft skills. Provide direct and actionable feedback.

Requirements

• Strong experience participating in internal and external audits (e.g., FDA, Notified Body, Supplier)
• Experience working within a highly regulated business such as Medical Device or Pharmaceuticals (other industries absolutely considered)
• Experience with CAPA's, Quality, Root Cause analysis, NCR's, Change Control, Engineering, Quality Assurance, Risk Management and Statistical/Quality tools.

Following your application Simon Trebilcock, a specialist Pharmaceutical Recruiter with over 8 years’ experience recruiting in the field will discuss the opportunity with you in detail. He will be more than happy to answer any questions relating to the pharmaceutical industry and the potential for your career growth. The conversation can also progress further to discussing other opportunities which are also available right now or will be imminently becoming available.

This position has been highly popular, and it is likely that it will close prematurely. We recommend applying as soon as possible to avoid disappointment. Please click ‘apply’ or contact Simon Trebilcock for any further information

Email -  strebilcock@planet-pharma.co.uk

Telephone - +44 (0) 203 868 1001 .

A note from the author – Simon Trebilcock

Don’t meet every single requirement? Studies have shown that women and people from minority groups are less likely to apply to job adverts unless they meet every single qualification. At Planet Pharma we are dedicated to building diverse, inclusive and authentic workplaces, so if you’re excited about this role but your past experience doesn’t align perfectly with every qualification in the advert, we encourage you to apply anyway. You may be just the right candidate for this or other roles.