Job Description

Job Title: Quality Manager
Reports To: Divisional Quality RA Sr. Director with a matrix report to Ashford Site Manager
Group/Division: LCD/LPG
Career Band: 07, Management
Location: Ashford UK
No. of Direct Reports: 6
Work Pattern: 37.5hrs Mon to Fri 9am to 5pm (supporting 24/7 as necessary)

Position Summary:
This leadership position is sits on the Ashford Senior Leadership Team and is accountable for:
1) Developing the site strategy and vision, and delivering the annual operating plans
2) Ensuring standardisation, implementation and maintenance of quality procedures and processes in the manufacturing and distribution of our products.
You will ensure a strong Quality Assurance presence exists across the site, maintaining existing quality systems (ISO 9001:2008 and 13485:2003), representing a strong interface with customers, suppliers and key accounts. Through effective leadership of the team, ensure standards are met and manufacturing / warehouse distribution is supported through ongoing assessment of performance and key priorities for both office based, laboratory and clean room quality assurance and inspection teams. You will be able to implement effective methods and change control processes, and be able to make Quality easy to understand and become part of the working environment across all departments. You’ll have up to date knowledge of the latest advancements and maintain that knowledge to develop and implement ongoing improvement and business justifications for effective change, utilising lean techniques and project management protocols.

Key Accountabilities:
• Responsible and accountable for all aspects of Quality at the Ashford site
• Develop annual Quality strategy aligned to a site strategy, KPIs and organisational goals to transition from QC to QA Monitor, review and maintain the ISO 9001 and ISO 13485 requirements at the Ashford site
• Maintain all documentation within the Quality area, and responsible for monitoring control of documentation throughout all areas.
• Provide leadership, direction and development to Quality Team employees whilst developing a high performing team, maintaining agreed standards individually and corporately, taking necessary action to address performance levels including annual appraisals.
• Develop and maintain a collaborative and supportive relationship with all other departments at site and in the wider organisation/matrix
• Generate and implements ideas that improve quality indicators, in line with cost, investment and service goals. Implement Lean Tools and practices – TQM, PPM, SPC.
• Lead the Non conformance and CAPA process to ensure true root cause is identified and remediated in a timely manner.
• Ensure a robust change management process is maintained across the site.
• Maintain and enhance the site Validation Master Plan, and develop and update new validation protocols
• Generate reports of non-conforming product internally and externally against individual departments
• Maintain close contact with technical services and/or customers concerning quality related concerns, requests and/or issues
• Actively involved in R & D for new / existing tooling and implementation of customer requirements
• Provides technical guidance and works closely with R & D, Product management, Manufacturing and Distribution on major new product introductions and acquisitions
• Assist R & D functions in planning of new tooling and associated test jigs/equipment
• Participate in divisional QMS projects incl. implementation of electronic QMS at Ashford Site


Minimum Requirements:

Essential:
5-10 years management experience in a Quality environment within forensic or laboratory products
Solid background from ISO 9001:2008 and some experience with ISO 13485:2003 experience
Working knowledge of ISO9001:2015 and ISO13485:2016 to be preferred
Proven ability to standardize, implement and improve processes

Strong capabilities within Root Cause Analysis
Degree educated preferably within a Scientific discipline
Lead Auditor Qualification & experience of internal, external and supplier auditing
Desirable:
Membership of the CQI (Chartered Quality Institute) or IQA (Institute of Quality Assurance)
Technical knowledge of plastics moulding process & process validation
Project management experience
Experience of Lean Manufacturing (Six Sigma or similar)
Process validation experience within Medical device
A working knowledge of Metrology