Senior Quality Systems Specialist RD
Senior Quality Systems Specialist RD
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Job Description
Job title: Senior Quality Systems Specialist R&D
Department: UK R&D Quality Systems
Location: Chandlers Ford Eastleigh
GLS: P03
Working hours: Monday Friday 37.5 hours per week Onsite role 5 days a week
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:
As a Senior Quality Systems Specialist within our UK R&D Quality Systems team you will work as part of a teammonitoring and improving all areas of the Companys Quality System including supporting and promoting quality assurance and compliance activities. This position focus on supporting the UK R&D QMS and any CooperVision global initiatives that UK R&D QA is involved in.
Specific responsibilities include:
- Able to lead and coordinate the following systems: Internal Audit External Audit CAPA Document Control Change Control NonConformances Deviations Batch review.
- Promotes the use and leads improvement initiatives of the internal Quality System processes in alignment with CooperVision Global Quality Systems and Regulatory Requirements.
- Performs Internal Audits including creating and reviewing of audit plans and reports leading and participating in internal audits communicating internal audit findings to appropriate personnel and working to ensuring the timely close out of actions derived from internal audit findings.
- Performs Supplier audits when requested; including creating audit plans and reports leading and participating in supplier audits communicating and managing audit findings with the supplier.
- Responsible for external audit workflows generated for the site ensuring all documentation is available relevant personnel is informed and all findings are timely closed.
- Supports Investigation Implementation and Review activities for CAPAs and NCRs working with CAPA & NCR Leaders and other RA/QA team members ensuring a consistent approach. Responsible for organizing CAPA Review Boards.
- Provides training support including but not limited to delivery of the Quality induction CAPA NCR Change Control and Internal Audit courses and any related administration activities as required.
- Able to manage trending and data reviews for global and site level quality system metrics and from this analysis:
- Communicate trends to the business.
- Propose a course of action or solutions to the analysis results for improvement.
- Supports Management review process leading the process of gathering interpreting and concluding on data.
- Provides administrative support to Quality Engineers as part of Concept Feasibility Design Control and Risk Management (filing document change control annual reviews etc.
A full job description is available upon request.
About you:
We are looking for someone with the following experience:
- Significant quality system experience working in a Medical Device Manufacturing environment
- Experience of working in Quality Assurance.
- Experienced auditor Qualified ISO 13485:2016 MDR and MDSAP is essential
- Agile knowledge and experience
- Working knowledge of quality systems processes and their interactions in a medical device manufacturing environment.
- Compliance level knowledge of 21 CFR 820 ISO 13485:2016 MDR MDSAP and other applicable quality system regulations is essential.
- Able to identify issues and/or assess opportunities in developing improving or remediating various aspects of the QMS
- Experience in applying risk management principles in the development of sterilized medical devices
- Ability to read and understand technical material.
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
What you can expect:
As a CooperVision employee youll be welcomed into a diverse and progressive global business. We appreciate how important fostering a diverse and inclusive culture is and how different perspectives add value and contribute to our success. With our CooperPride African Descent Womans Impact Network and Mind Body and Wellbeing Employee Resource Groups we offer opportunities for employees to learn and grow within an inclusive and safe space.
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
#LIGA1
#LIONSITE
#INDHP
Required Experience:
Senior IC
Employment Type
Full-Time
