At a Glance
- Tasks: Lead projects ensuring compliance and performance of medical device packaging and labelling.
- Company: Join a leading medical device company focused on innovation and quality.
- Benefits: Competitive salary, generous holiday, private medical insurance, and career development.
- Other info: Collaborative team environment with opportunities for mentorship and growth.
- Why this job: Make a real impact on global health by ensuring the safety of medical devices.
- Qualifications: Degree in a technical field and experience in regulated environments required.
The predicted salary is between 58000 - 62750 £ per year.
Shape the Future of Medical Device Compliance. We are looking for an experienced Senior Packaging & Labelling Engineer to join our Validation & Sterility Assurance team based onsite in Cirencester. This is a pivotal role responsible for ensuring the compliance, performance, and continuous improvement of our medical device packaging, labelling, and packing systems across a global portfolio. As the subject matter expert for packaging and labelling validation, you will lead critical projects, support regulatory compliance activities, mentor a small team, and work closely with colleagues across Quality, Regulatory Affairs, R&D, Manufacturing, and external partners. This is an excellent opportunity for a driven engineer who enjoys technical problem-solving, project leadership, and influencing business-wide quality and compliance strategies within a highly regulated medical device environment.
What You'll Be Doing
- Monitor and validate all aspects of medical device packaging and labelling, including:
- Transportation testing
- Shelf-life studies
- Equipment performance validation
- Labelling control systems
- Label content compliance
- Support a global portfolio of medical devices, including orthopaedic implants, reusable instruments, and single-use devices.
- Review and approve technical documentation, labels, and packaging Bills of Materials (BOMs).
- Drive continuous improvement of packaging and labelling validation strategies.
- Manage validation and improvement projects, including:
- Equipment qualification and validation
- Product evaluations
- New system implementation
- Collaborate with cross-functional global teams, including Regulatory Affairs, R&D, Quality, Operations, contractors, and external laboratories.
- Ensure regulatory compliance deadlines are achieved and maintained and provide technical responses to regulatory authorities.
- Develop and deliver training to operational teams.
- Lead investigations relating to non-conformances, CAPAs, and customer complaints.
- Act as an auditee during internal, customer, and regulatory audits.
- Mentor, supervise, and develop a small team, including participation in recruitment activities.
What We're Looking For
Essential
- Degree in a scientific, engineering, or related technical discipline.
- Proven experience within the medical device industry or another highly regulated environment.
- Strong understanding of packaging and labelling validation requirements.
- Experience working with:
- ISO 13485
- ISO 11607
- 21 CFR 820.75
- MDR and/or MDD
- ASTM standards
- Knowledge of Good Manufacturing Practice (GMP).
- Strong analytical, investigative, and problem-solving skills.
- Excellent attention to detail.
- Ability to manage multiple priorities and complex technical projects.
- Strong written and verbal communication skills with the ability to influence stakeholders at all levels.
Desirable
- Previous experience mentoring, coaching, or supervising others.
- Experience leading validation projects within a medical device manufacturing environment.
- Exposure to regulatory inspections and external audits.
- Experience of packaging equipment validation and qualification.
Why Join Us?
- Play a key role in ensuring the safety and compliance of innovative medical devices used worldwide.
- With the opportunity to lead impactful projects within a collaborative, cross-functional environment.
- A competitive salary of £58,000 - £62,750 and a discretionary annual bonus.
- 25 days holiday plus bank holidays.
- Excellent pension – starts at 6%, going up to 9.7% after 18 months.
- Life assurance – Six times your basic salary.
- Private medical insurance with BUPA for you and your family.
- Free annual eye tests and flu vaccinations.
- Employee referral program where you can earn from £1,000 for each successful hire you recommend.
- Opportunity to work on regulated, high-impact medical device products.
- Ongoing professional development and career progression opportunities.
- Be part of a business committed to quality, innovation, and improving patient outcomes.
Apply Today
If you're an experienced packaging and labelling professional looking to take the next step in your career and make a tangible impact within the medical device industry, we'd love to hear from you. Apply now and help us deliver compliant, high-quality medical devices that improve lives around the world.
Senior Packaging and Labelling Engineer employer: Corin
Corin is an exceptional employer that fosters a collaborative and innovative work culture, particularly for those in the Senior Software Quality Engineer role. With a strong commitment to employee growth, you will benefit from a hybrid working environment, generous holiday allowance, and comprehensive health benefits, all while contributing to groundbreaking technologies that enhance patient outcomes globally.
