Sector: Life Sciences
Consultant: Harvey Havell
Salary: £47000 - £52000
Job Status: Permanent / Full Time
JOB TITLE: Product Quality Manager – Medical Devices
LOCATION: Cheltenham, Gloucestershire
REPORTING TO: Engineering and Quality Manager
RESPONSIBLE FOR TEAM OF: 5 (Senior Quality Technician, 2 x Quality Technicians, Quality Assurance Engineer & Microbiology Specialist)
SALARY: up to £52K
Key purpose of role
This role is to provide leadership, guidance and support to site quality team in the execution of quality management system, policies, and procedures. This includes incoming, in-process and outgoing product quality, liaising directly with suppliers and customers. It is a hands on role requiring a can do attitude, excellent communication and people management skills.
Responsibilities of the role
- Person responsible for regulatory compliance (ref EU 2017/745 Art. 15). Responsible for ensuring that: the conformity of the medical 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.
- Liaise directly with customers on quality concerns / issues and ensures they are dealt with promptly and effectively.
- Leads, supports, and facilitates complaint investigations, root cause analysis, and the implementation of effective corrective actions.
- 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.
- Internal & External auditor, lead &/or support audits (FDA 21 CFR 820, ISO13485, ISO 9001, Customers) assessments.
- 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
If this is of interest, please click the apply now button. If you have any questions or queries, please get in touch with Harvey in the Life Sciences team.