Quality Manager

Overview

Austin Vita is pleased to be offering a great opportunity for a Quality Manager to join our client, a Global Medical Device business based in Wiltshire. This is a great position for someone with broad scoped quality experience within medical devices and people leadership.

You will lead and co-ordinate the actions and improvement activities of the team in meeting customer quality requirements which will include the maintenance of Quality Assurance systems throughout the site. Acting as the key contact & Quality Management Representative for all matters concerning Quality for the facility.

Benefits

• Pension Scheme
• 25 days annual leave
• Private Medical Insurance
• Life Insurance
• Flexi working

Responsibilities

• Manage all Quality control activities on site
• Champion a dynamic and proactive quality culture
• Design and facilitate Internal Audit programmes to cover ISO13485 / GMP
• Implement and maintain ISO13485 / GMP / FDA / Medical device standards in R&D, QA and Process areas
• Document, review and approve Customer Specifications
• Setting and maintaining standards of performance, reporting Quality KPI'S
• Ensuring key raw material specifications are aligned to customer specifications
• Ensuring incoming goods are conforming to specification
• To integrate with both customers and suppliers with regards to quality problem resolution and improvement initiatives
• Facilitate reporting and actions on internal and external customer complaints
• Ensure all bio-burden and pest controls are compliant to standard
• Facilitate the completion of customer questionnaires
• Represent other UK sites in second and third party audits
• Ensuring effective communication within the team
• Ensuring a safe and clean working environment
• Supporting the development of new product

Skills/Experience

• Knowledge of global Regulatory and Quality requirements for the manufacturer and marketing of drugs and medical devices
• Quality Assurance Leadership experience in a medical manufacturing facility
• Knowledge of Quality systems and manufacturing processes in medical device and/or pharma industries
• Demonstrated experience interfacing with FDA/Regulatory inspectors and customers during customer audits
• A minimum of 5 years relevant experience within the regulatory affairs discipline, including Medical Device, Biotechnology, and/or Pharmaceutical experience.
• Preferably degree-qualified or experience gained in a medical manufacturing facility.
• Certification as an Auditor in the area of ISO 13485 standards would be advantageous.

For immediate consideration please forward your most up to date CV

Austin Fraser is acting as an Employment Agency in relation to this vacancy.

Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.