We are currently seeking and experienced Quality Compliance Officer for our client who are a global leader within their field.  Working at their UK Head Office this role offers an excellent salary, plus a range of flexible benefits which you can tailor to meet your individual needs. Joining this organisation will offer the opportunity work within a dynamic business who promote innovative flair and working collaboratively, it will also provide the scope to integrate with a diverse range of people who all contribute with varying views, perspectives and priorities.         

This exciting opportunity will be reporting to the Head of Quality Assurance/Regulatory Affairs and the successful candidate will be involved in the implementation, maintenance and continuous improvement of the company's Management System, primarily in relation to the ISO 13485 certified manufacturing and commercial operations branch of the business.

Key Activities:

• Ensure the high profile management systems are maintained in line with ISO 13485 and ISO 9001:2008.
• Act as the primary QA lead for the CAPA process and all CAPA related investigation, including root cause analysis and chairing progress meetings.
• Act as lead auditor for internal and supplier audits as well as oversee timely close out of audit actions.
• Support the QA Management team during external certification and accreditation audits.
• Document control activities including issuing, tracking and controlling documentation; as well as raising and reviewing relevant departmental procedures.
• Record and analysis of monthly metrics and trend reviews of key processes.
• Provide training to all members of staff ensuring they are fully trained and knowledgeable on QMS, GMP, GDP, CAPA, Root Cause Analysis, etc.
• QA signatory for approval and ongoing evaluation of suppliers as well as support to the supply chain team in resolution of supplier discrepancies.
• QA review and approval of validation plans, risk assessments, protocols and reports.
• Operation and maintenance of key processes such as Change control, CAPA, Deviations, Non-conforming product.

The organisation is an ISO 13485, ISO 9001 and ISO 17025 certified and accredited company.  All duties must be carried out in accordance with these standards.

Position Requirements

Formal Education & Certification

• University degree in scientific field or relevant experience
• Lead Auditor certified in ISO13485 or relevant experience is essential.

Knowledge & Experience

• 5 years direct work experience in a senior Quality Assurance role
• 5 years direct work experience with maintaining medical device quality management systems, in accordance with ISO13485.
• Experience in Risk Management, in accordance with ISO14971, is desireable.
• Experience in developing and deploying quality assurance best practices, policies, procedures, and processes.
• Must have a full clean driving license - must be prepared to travel and work away as when required by the company

Personal Attributes

• Experience at working both independently and in a team-oriented, collaborative environment is essential.
• Advanced interpersonal, written, and oral communication skills.
• Must be able to learn, understand, and apply new technologies.
• Ability to effectively prioritize and execute tasks in a high-pressure environment is crucial.
• Tenacious.
• Persuasive, encouraging, and motivating.