Location: Hamble, Southampton, UK
Working Hours: Mon – Fri, 37.5 hours per week
Job Description
CooperVision is one of the world’s leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of CooperVision means helping improve the way people see each day. It’s more than making contact lenses, it’s about giving lens wearers freedom and confidence to move about their daily lives. We’re all about bright futures – for our people and those who wear our contact lenses.
Job Title
QA Laboratories Manager
Department
Quality Assurance
Scope
Reporting directly to the Director QA/RC, the QA Laboratories Manager shall manage a team and ensure that all microbiological testing, autoclave validations, and materials testing are performed in accordance with Standard Operating Procedures and are compliant with applicable medical device regulations and ISO standards. This role is a business partner to manufacturing to ensure risk mitigation and appropriate actions are taken in a timely manner to ensure safe and compliant products are released and, if required, for appropriate action to be recommended and taken.
Job Summary
To manage the QA Laboratories Department and supervise the staff and workload of the Microbiology and Autoclave departments and to ensure compliance with regulatory requirements.
Essential Functions & Accountabilities
* Manage the QA Laboratories departments of Microbiology, Autoclave, and Materials testing.
* Ensure all incoming materials are tested and accepted in accordance with specifications and medical device regulations and standards including ISO13485, MDD, MDR, FDA QSR.
* Train Microbiology laboratory technicians ensuring safety procedures are followed and required training is completed and recorded on time.
* Organise the workload to maintain the required level of routine monitoring and non-routine work to support Business Unit projects.
* Validate the test methods used in the laboratory and for other microbiologically related procedures such as the effectiveness of disinfection.
* Act as process owner for QA Laboratories and Microbiology, supporting external audits by notified bodies and health authorities.
* Process and approve Materials and Microbiology data in a timely manner to support business production and release targets.
* Lead and participate in Engineering Change Orders (ECO), supporting Business Unit projects with Risk Assessments and Engineering studies.
* Lead and participate in risk management teams.
* Lead CAPA investigations, complete CAPA Investigation reports and identify/implement corrections, corrective actions and preventive actions as appropriate. Raise and review NCRs to ensure correct product disposition.
* Apply Six Sigma methodology (Define, Measure, Analyse, Improve, Control) and participate in Six Sigma improvement projects.
* Use aseptic technique for sampling of water, solution systems and un-autoclaved lenses and testing for bioburden.
* Record test results and maintain trend analysis.
* Perform environmental monitoring (settle plates, air sampling, personnel monitoring) in wet production areas and maintain trend analysis.
* Review results and investigate areas of microbiological concern or contamination.
* Identify isolates as required.
* Review autoclave validation reports to ensure compliance with respective Testing Monographs.
* Provide GMP and introduction to Microbiology training for working in Areas of Specified Environmental Cleanliness (ASECs) and sterilisation theory training in the absence of the Autoclave Validation Specialist.
* Set departmental budget and reforecast when required.
* Perform any other related duties connected with the Company’s business.
Travel Requirements
Local travel between UK sites is necessary, as required. International travel to other CooperVision sites – no more than 5% of the time (approximately 3 weeks per year).
Knowledge, Skills And Abilities
Strategy
* Leverage professional expertise, external insights, customer & consumer needs to drive long‑range strategic thinking.
* Develop distinctive strategies to achieve and exceed expected performance through process and people.
* Share a vision that inspires and engages people.
* Translate broad strategies into specific objectives, projects and action plans.
* Align the organisation to understand how every role supports strategic priorities.
Organisational Capability
* Attract and retain high‑calibre talent.
* Build an inclusive, engaged culture that values diverse backgrounds and perspectives.
* Accurately appraise the strengths and weaknesses of others, providing coaching and constructive feedback.
* Inspire, motivate and develop the team to achieve exceptional outcomes.
* Develop a talent pipeline to ensure successors and talent pools to support future needs.
Results
* Hold self and others accountable to achieve business results.
* Sponsor and direct change while maintaining operating effectiveness.
* Address root causes of issues and enable innovation and continuous improvement.
* Establish stretch goals, monitor results and budget, demonstrating financial acumen.
* Make effective decisions by swiftly and critically considering risks, costs and benefits.
Impact
* Build strong internal and external relationships based on honesty, candor, trust and respect.
* Understand the role/interrelationships of each organisational function and demonstrate enterprise‑wide thinking.
* Effectively manage priorities collaboratively across organisational groups to achieve the best business outcome.
* Facilitate teamwork and honest communication across the organisation.
* Listen, clarify to understand intent, and skilfully share information with others.
* Exhibit excellent communication skills, both verbal and written, and connect with clarity at all levels within the organisation.
Mature Leadership
* Open to learning, feedback and realistically appraise own strengths and weaknesses.
* Maintain confidence, resilience and agility when challenged or facing adversity.
* Address issues directly with a fair and balanced approach, keeping company interests in mind.
* Model high integrity and live the organisational values.
* Recognise high performance.
* Delegate effectively and achieve results through other individuals and teams.
Work Environment
The role operates primarily in an office environment but will require entry to Areas of Specified Environmental Cleanliness (ASEC) to assess processes and changes, and to the Microbiology Laboratory when required to cover for the Microbiology Technicians.
Experience And Education
* Minimum five years in the contact lens or medical device industry.
* Minimum of ten years in a Microbiology Laboratory setting.
* Experience in the medical device industry, group direct reporting, and laboratory investigations.
* Experience in laboratory equipment (HPLC, GC, TOC, IR, UV, incubators, autoclave, air sampler, etc.).
* Experience in Quality Systems audits.
* Minimum seven years in a Management/Supervisory capacity.
* Minimum Bachelor of Science degree in Microbiology or Biological Sciences or related discipline and proven Microbiology background in the Medical Device sector.
What we offer
You’ll receive competitive compensation and a fantastic benefits package including bonus, private medical insurance, 25 days holiday, pension scheme, 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. We also provide access to LinkedIn Learning.
What you can expect
As a CooperVision employee, you’ll be welcomed into a diverse and progressive global business. We appreciate how important fostering an inclusive culture is and how different perspectives add value and contribute to our success. All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.
If you like what you see, take the first step towards your Brighter Future and apply today! Please view our careers page at https://hcjy.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1 to view all other opportunities.
#J-18808-Ljbffr