At a Glance
- Tasks: Lead global stability programs and ensure compliance with industry standards.
- Company: Join a leading medical device company focused on innovation and quality.
- Benefits: Competitive salary, private medical insurance, 25 days holiday, and wellness support.
- Other info: Dynamic work environment with opportunities for personal and professional growth.
- Why this job: Make a real impact in the medical field while advancing your career.
- Qualifications: 5-10 years in Quality Engineering and a relevant degree required.
The predicted salary is between 60000 - 75000 £ per year.
The Stability Program Lead establishes minimum stability requirements and maintains current procedures, systems, and tools supporting stability studies worldwide. This role coordinates closely with global manufacturing sites, project managers, and execution teams to ensure timely, compliant stability execution.
Responsibilities include management of Documents of External Origin (DOEO) related to stability requirements and regulatory updates. The role also partners with R&D to define stability requirements for New Product Introductions (NPIs), aligned with ISO 10993, and provides technical guidance on product, process, or material changes that may impact product stability.
The Stability Program Lead provides global leadership and oversight of the contact lens stability program, ensuring compliance with ISO 11987, applicable regulatory requirements, and internal quality standards. As the Global Process Owner, this role defines and maintains standardized stability requirements and drives consistent, compliant execution across global manufacturing and development organizations.
Essential Functions & Accountabilities
- Develop and maintain the stability program in accordance with ISO 13485, ISO11987, MDSAP, and other applicable regulations.
- Ensure stability protocols, reports, and data meet regulatory and internal requirements.
- Act as the primary liaison between manufacturing sites, project managers, and execution teams in Puerto Rico and the UK.
- Ensure proper sample allocation and timely initiation of stability studies.
- Establish minimum requirements for stability testing and documentation.
- Update and maintain stability-related procedures and systems to reflect current regulatory and business needs.
- Manage and control Documents of External Origin (DOEO) to ensure compliance and traceability.
- Partner with R&D to define New Product Introduction (NPI) stability requirements in alignment with ISO 10993.
- Provide guidance on product and process changes, assessing their impact on the stability program.
- Review stability protocols and reports for completeness and compliance.
- Provide oversight for data integrity and ensure readiness for audits and regulatory submissions.
- Identify opportunities to streamline stability processes and enhance program efficiency.
- Stay current with regulatory changes and industry best practices related to stability programs.
Travel Requirements
The position requires 5% travel between the execution sites and may also require travel to attend global business meetings.
Knowledge, Skills and Abilities
- Ability to influence across functions, with a demonstrated track record of driving global initiatives to successful completion.
- Strong analytical and problem‑solving skills, with the ability to interpret data, identify trends, and assess quality and regulatory risk.
- Excellent written and verbal communication skills, with the ability to clearly articulate regulatory expectations, technical concepts, and quality risks to diverse stakeholders.
- Strong organizational and prioritization skills, capable of managing multiple priorities in a fast paced, global environment.
- Proficiency in Microsoft Word, Excel, Project, and other relevant quality or data management systems.
- High attention to detail.
- Ability to work effectively in a multinational and multicultural environment.
- Consistently models corporate values and demonstrates integrity, accountability, and professional conduct.
Work Environment
Primarily office‑based role with extended periods working at a computer. May require long hours during critical project phases or regulatory activities. Involves coordination and handling of product samples as needed.
Experience and Education
- 5–10 years of experience in Quality Engineering, Quality Assurance, or Quality Systems, preferably within the medical device industry.
- Demonstrated experience leading, executing, or overseeing stability studies and accelerated/real time aging protocols across the product lifecycle.
- Working knowledge of domestic and international regulatory requirements, including but not limited to ISO 13485, MDD, MDR, and MDSAP.
- Bachelor’s degree in Engineering, Life Sciences, Chemistry, Biology, or a related technical discipline required.
Benefits
Competitive compensation and a fantastic benefits package including bonus, private medical insurance, 25 days holiday, pension scheme, access to a Wellness Platform to support mental health and wellbeing, discounted contact lens scheme, and much more. We are committed to employees’ personal and professional development and offer extensive training to support career growth. Additional resources such as LinkedIn Learning are available to help develop in your career and grow with CooperVision. All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.
Stability Program Lead in Fareham employer: CooperVision Limited
CooperVision is an exceptional employer located in Hamble, Southampton, offering a dynamic work environment that prioritises employee well-being and professional growth. With a competitive benefits package including private medical insurance, generous holiday allowance, and access to wellness resources, employees are supported both personally and professionally. The company fosters a culture of collaboration and innovation, providing extensive training and development opportunities to help you thrive in your career as a Stability Program Lead.
