Group Quality Manager Job In Mildenhall

Group Quality Manager

  • £36000 - £40000 per annum
  • Posted: 26/03/2019
  • Mildenhall
  • Job Ref: 311101035
  • Permanent

Job Details


Our client are looking for an experienced Group Quality Manager to join their reputable and established company and help the company with their future progression

Role and Responsibilities

Provide Operational and Managerial Support for all matters regarding Quality Assurance monitoring, implementation and Development of the Business.

Current expansion in their companies means that this position is offering the opportunity for the right candidate to support and be a key influencer in the future development and growth of the business . We are a manufacturer of Medical Devices ranging from Class 1 through to Class III that are used within a wide range of interesting and challenging medical fields. Plus our other company is a Global provider of training solutions for Military and Law Enforcement Agencies .

The requirements of the job role will include:

Manage the Quality Management System through development, review and authorisation of Policies and Standard Operating Procedures.

To provide quality assurance support and direction for all areas of the business.

Work with Senior Management to support and develop a strategy of continuous improvement

Working with all areas of the business to produce and maintain quality system documentation to the requirements of ISO 13485:2016 & ISO9001:2015 and ensure compliance with latest regulations

Maintaining compliant and effective procedures to meet the business needs

Managing effectively all local procedures, work instructions and associated documentation

To manage and maintain all document control and change control activities.

Supporting the business units in terms of quality management and the establishment of effective procedures of new products and processes, refinement of existing products and processes and resolution and communication of quality issues.

Continue to drive the implementation and improvement of the Quality Manual and associated procedures

To manage and maintain all document control and change control activities.

Prepare quality documentation and reports by collecting, analysing and summarising information and trends including failed processes, corrective actions, and re-validations

To assess vendor suitability in accordance with company Standard Operating Procedure

Champion the proactive management of key Innovation suppliers from a quality perspective; ensuring the needs of projects and QMS are maintained and continuously improved

Maintain and improve product quality by completing product, company, system, compliance, and surveillance audits;

To be a pivotal contributor to all internal, external, regulatory inspections and audits.

Control the preparation and management of regulatory inspections and external audits as well as developing CAPA (Corrective Action Preventative Action) plans resulting from the audits/inspections.

Managing the programme of internal audits to support the verification of QMS effectiveness and drive continuous improvement.

Host quality audits from both our regulatory body and customers

Undertake staff training in QA procedures.

Identify and support QA staff development and training to enhance skills and strength of the business

Supervise and coach QA teams, Operations, Engineering, technicians and other staff in effective quality procedures

Investigate customer complaints and initiate internal investigations

Accountable for raising of Non-conformances and activities associated to CAPA

Responsible for Post Market Surveillance and Vigilance activities with medical devices on the market.

Assure the reliability and consistency of production by checking processes and final output

Assume responsibility for the day to day management and maintenance of the QMS

Develop quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures

Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining installation, operational and performance qualification; writing and updating quality assurance procedures.

Quality Assurance Management experience of at least 2 years
Six Sigma Training useful but not essential.
Experience working within an ISO (phone number removed) & 9001:2015 QMS systems.
Experience of database /spreadsheet software and associated reporting skills
Proven relevant experience in the operation of quality systems, including audits and regulatory disciplines
Experience in the use of analytical tools required for maintenance and development of new products and processs – FMEA / R & R gauge studies .
93/42 MDD, 2017/745 MDR and FDA awareness preferred
Must be computer literate and have a very good written & verbal use of English language.
Occasional worldwide and national travel may be required.
A methodical thinker, capable of making rational judgments
Ability to communicate with all levels of the organization along with external professionals and regulatory and notified bodies.
A hands-on mentality is required.
Additional training may be available as part of a continual personal and departmental development program
This role is an ideal opportunity for someone looking for personal growth in a rapidly growing business

If you have the experience and knowledge then please either call Teresa Maykels on 01842 820 494 or email your cv to