Product Quality Manager – Medical Devices

Location: Gloucestershire  |  Gloucestershire  |  England
Sector: Life Sciences
Consultant: Stewart McGrath
Job Reference: HQ00000535
Salary: £47000 - £47000
Job Status: Permanent / Full Time

RESPONSIBILITIES OF THE ROLE:

  • Person responsible for regulatory compliance (ref EU 2017/745 Art. 15). Responsible for ensuring that: the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released
  • Promoting, and leading quality achievement and performance improvement across the organisation
  • Maintains and follows all site Quality Management System (QMS) and regulatory requirements that can affect the quality of products, processes, or services provided to our customers.
  • Leads, supports, and facilitates complaint investigations, root cause analysis, and the implementation of effective corrective actions.
  • Internal & External auditor, lead &/or support audits (FDA 21 CFR 820, ISO13485, ISO 9001, Customers) assessments.
  • Liaise directly with customers on quality concerns / issues and ensures they are dealt with promptly and effectively.
  • Liaise with the notified body on all matters related to the external accreditation process.
  • Vigilance reporting to the notified body and managing field actions
  • Support the NPD & NPI process (Quality Engineering IQ, OQ, PQ, pFMEA, Risk Management activities)including the component approval process and control plans.
  • Assessing product specifications and customer requirements
  • Bringing together staff of different disciplines and driving the group to formulate and agree comprehensive quality procedures
  • Supervising technical staff in carrying out tests and checks.
  • Ensuring tests and procedures are properly understood, carried out and evaluated and that product modifications are investigated if necessary
  • Understand Component Drawings and advise on appropriate metrology techniques to measure specified dimensions.
  • Excellent numerical skills with an understanding of statistics
  • Ability to program and operate CMM.
  • Collating and analysing performance data against defined parameters
  • Writing technical and management system reports
  • Pinpointing relevant quality-related training needs
  • Accountable for departmental performance against key performance indicators

Supply chain management

  • Provides support in the evaluation and management of internal and external supplier quality.
  • Working closely with purchasing staff to establish supplier quality performance criteria and monitor supplier performance
  • Assessing suppliers’ product specifications and quality plans
  • Supervising the programme of supplier audits

QUALIFICATIONS AND EXPERIENCE:

  • Previous experience as a Quality Manager within a medical device or pharma company. This should include supplier quality management, liaising with customers and notified bodies
  • Degree or technically qualified in a related engineering discipline
  • Working knowledge of lean manufacturing, six-sigma and other continuous improvement techniques desirable.
  • Excellent communication and people management skills
  • Ability to work under pressure with multiple priorities
  • Highly numerate and analytical with strong problem solving skills
  • Proven planning, change management and organisation skills

You will be working alongside the fastest growing recruitment company in the UK, who provide an unrivalled service to all of their clients and candidates across the United Kingdom. Seven currently offer the best contractor pay rates in the UK for Life Sciences, making us the best option for maximising your earning potential and career fulfilment. Seven Consultants are passionate about placing you in the best possible role, for the best possible rate, while providing a support platform, which is accessible around the clock.

Are you ready for the challenge? If so, we look forward to hearing from you.

What else can you expect from Seven?

– Specialist Consultant allocated to you with all the expertise you require.

– Excellent Payroll and Compliance System, ensuring that you are paid on time, every time.

– Access to Exclusive Rates, allowing you to gain earnings that no other agency can offer you.

– £250 Referral Bonus for every person you successfully refer to Seven.

If you are interested in this opportunity, please call 020 3887 7365. Please ask for Stewart McGrath in the Life Sciences team.