Founded in 1989, Flexicare is a global medical device company specialising in airway management and respiratory solutions, supported by a complementary portfolio that extends across critical care, respiratory technique and urology, giving us on the of the broadest ranges in our sector.
Become Part of the Team
As Quality Engineer you will be responsible for providing quality oversight to manufacturing operations in UK (contract manufacturing operations) to ensure compliance with internal quality standards, regulatory requirements, and customer expectations, as well as operational controls for outsourced manufacturers (suppliers).
What You'll Do
- Manufacturing Quality Oversight: Ensure manufacturing processes meet internal standards, regulatory requirements, and customer expectations, providing guidance and support to supply chain and manufacturing teams.
- Validation Support: Participate in or review process validation, ensuring proper controls, documentation, and data integrity.
- Problem Investigation & RCA: Lead and support root cause analysis of quality issues, implement corrections (NCs) and corrective and preventive actions (CAPA).
- Compliance & Documentation: Maintain and approve quality documentation, including control plans, inspection procedures, validation documents. Supports the on-going maintenance of Quality Management System documentation related to Quality Operations such as SOPs, WIs and forms. Adheres to company procedures in line with good documentation, manufacturing and engineering practices.
- Change Management: represent Quality in change management activities, reviewing change proposals – assisting in identification of the required implementation activities to see a change compliantly to implementation. Support technical document updates/approvals
- Supplier & Component Quality: Oversee the whole supplier management process: evaluate new suppliers for onboarding, manage the Approved Supplier List (ASL) including all supporting supplier documentation, measure metrics reflecting supplier performance, execute supplier audits in line with the audit schedule, manage supplier CAR process.
- Manufacturing Transfer: in line with change management activities, represent Quality in projects involving setting up new manufacturing locations, moving products between Flexicare manufacturing sites, or to external suppliers.
- Auditing: Support effective auditing both via internal audits or supplier audits.
- Monitor, maintain, analyse and routinely report quality performance metrics for the Operations team, identifying trends and driving improvements.
- Continuous Improvement Support: Collaborate with manufacturing to ensure process improvements do not compromise product quality.
We believe you're the right fit if you have
- 3+ years of experience in manufacturing, preferably the medical device industry.
- Auditing and documentation
- Demonstrated experience with risk management and problem solving
- Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook and related software)
- Ability to work independently and internationally
- Good communication skills – both written and oral.
- Strong collaborative skills – confident to inform and influence diverse stakeholder groups.
- Experience with risk management and problem solving
Desirable but not essential
- Bachelor's degree in engineering (Manufacturing, Material, Biomedical or related field)
- Familiarity with ISO 14971
- ISO 9001 experience
- Plastic Manufacturingexperience
What You'll Get
- Competitive Salary in accordance with experience and capabilities
- Pension
- 33 days Holiday per year incl Bank Holidays
- Benefits package: Life Assurance (x2), Income protection (50% of salary), Health Cashplan (Medicash), Benefit pot - for spending on additional benefits, which include: Upgrade Health Cash plan, Critical Illness cover, Cycle to work, Tech Benefits, Will Writing, or add it to your pension pot if not used.
Due to the high volume of applications anticipated for this role, we regret that we will only contact candidates selected to progress to the next stage of the recruitment process.
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Quality Engineer in Mountain Ash employer: Flexicare Global
Flexicare Global is an exceptional employer that prioritises employee development and regulatory excellence within a supportive work culture. Located in the picturesque Mountain Ash, our team enjoys a collaborative environment where innovation thrives, alongside opportunities for professional growth in the quality compliance sector. Join us to make a meaningful impact while benefiting from our commitment to employee well-being and career advancement.
