Senior Quality Specialist - Quality Systems (2yr FTC)
Senior Quality Specialist - Quality Systems (2yr FTC)
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Job Description
Job title: Senior Quality Specialist Quality Systems 2 year Fixed Term Contract
Department: RAQA
Location: Hamble Southampton
GLS: M02
Working hours: Monday Friday 37.5 hours per week - 5 days a week on site
A brighter future awaits you
CooperVision is one of the worlds leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of CooperVision means helping improvethe way people see each day. Its more than makingcontact lenses its about giving lens wearers freedom andconfidence to move about their daily lives. Were all about bright futures for our people and those who wear our contact lenses.
Job summary What to expect:
We have an exciting 2 year Fixed Term Contract opportunity for a Senior Quality Specialist Quality Systems to join the RAQA team in Hamble.
The Senior Quality Systems Specialist is responsible for the management of key Quality System processes within UKM through your own knowledge and through the management of the Quality Systems Improver Team. This includes monitoring compliance reporting on trends and initiating and leading continuous improvement initiatives. Not only does this role manage the Quality Systems Improver team but also interacts with Manufacturing and Support functions within UK Manufacturing (UKM) to ensure compliance and continuous improvement of the Quality System.
Specifically you will
- Management of the Quality Systems Improver Team.
- Coordinates and manages the CAPA Process within UKM including but not limited to:
- Identifying and raising CAPAs
- Managing compliance to timelines through the use of extensions
- Support of CAPA Leaders with Root Cause Analysis
- Management of the CAPA Review Board (CRB)
- Coordinates and manages the Internal Audit program within UKM including but not limited to:
- Generation of the annual Internal Audit schedule
- Ensuring the audit schedule is executed according to planned arrangements
- Management and trending of non-conformances
- Ensuring the provision of trained Internal Auditor resource
- Performing Internal Audits
- Supports the execution of Management Review by scheduling generating and analyzing data and completing required records.
- Performs and analyses Quality System process performance using appropriate measures and KPIs. Report these trends to key stakeholders and proposes actions for improvement.
- Generates and analyses Business level KPIs which are reported to local and global stakeholders in conjunction with Manufacturing QA Teams.
- Support the development and delivery of training sessions on the subject of Quality Systems (e.g. CAPA Internal Audit).
- Support other sites within the QMS and globally with Quality Systems expertise.
- Development management and continuous improvement of Standard Operating Procedures (SOPs).
- Any other duties as directed by QA Management.
A full job description is available upon request.
About you:
We are looking for someone with the following essential experience
- Experienced Leader including all aspects of people leadership (objective setting personal development etc.) would be highly desirable.
- Experience in a Medical Devices Manufacturing environment and / or experience working in Quality Assurance (QA) is essential.
- Working knowledge of the application of a Quality Management System (QMS) as described in ISO13485 is essential.
- Experienced Internal auditor is essential
- Working knowledge of Quality Systems processes and their interactions in a Medical Device manufacturing environment in particular Corrective & Preventive Action (CAPA) Internal Audit and Management Review.
- Computer literate with intermediate skills in the use of Microsoft Word Excel and Outlook and some knowledge of relational database systems e.g. Agile Project Management System.
What we offer:
Youll receive competitive compensation and a fantastic benefits package including;25 days holiday private medicalpension scheme healthcare cover life assurance access to our Wellness Platform to support you in mental health and wellbeing a discounted contact lens scheme and much more!
We are committed to our employees personal and professional development and offer extensive training to support your career growth and help every individual to reach their full potential. To help us achieve our goals well give you everything you need to help you achieve yours.
We also provide access to LinkedIn Learning to help you develop in you career and grow with CooperVision
If you like what you see take the first step towards your Brighter Future and apply today!All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.
Please view our careers page at view all other opportunities.
Qualifications
#LI-GA1
#LI-ONSITE
#INDHP
Required Experience:
Senior IC
Employment Type
Full-Time
