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Senior Engineer Advanced Quality
2 months ago
Become Part of the Team
With over 35 years of experience, Flexicare is a leading designer and global provider of medical devices that enhance patient care. Headquartered in the UK, we support clinicians worldwide with class-leading devices and a global network of subsidiaries across over 100 countries. Flexicare has ambitious plans for international growth and we want you to be a part of our journey
What You'll Do
You will form part of our growing global Quality Team, providing leadership and direction in quality assurance, control and preventative activities within operations and other business functions. You will have a focus on preventative measures and continuous improvement of products and processes. Whilst advocating and leading the execution of initiatives and projects to enhance quality performance, you will mentor and provide technical direction across multiple areas of expertise.
- Work closely with R&D, clinical and operations and other business functions to ensure quality performance of product and processes.
- Mentor, provide oversight and approval of validation plans, protocols, reports and requirements specifications, activist and high level expert in problem solving and root causing activities.
- Initiate and lead in the development and improvement of processes for existing and new products using a risk based approach
- Initiate and lead in the development of PHAs, pFMEAs, dFMEAs
- Lead regular risk meetings
- Participate in monthly trending meetings
- Site Process Owner design quality and risk management
- Oversight and lead risk management investigations for HHE, PFAs, NCs and CAPAs
- Review and approval of change management activities from a risk and validation perspective, challenge change effectiveness and risk and drive strong review.
- Interpret complaints and NC trends from a risk perspective, take action as necessary, driving a continuous improvement process.
- Subject matter expert in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.
- Proficiency in providing technical direction in optimization of validation methods and sampling.
- Participate in and lead internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. Act as SME for design quality and risk management
- Support manufacturing and design transfers, leading quality activities.
- Support of ship, product Holds, potential product escapes from a risk perspective
- Coach and mentor the R&D and other business functions in quality topics and activities, with several topics at expert level.
- Deputise proficiently for management in temporary absence, periodic review boards, business meetings etc on a regular basis.
Who You Are
We believe you're the right fit if you have
- Previous experience in a regulated environment
- Proficient understanding of Medical Device manufacturing processes
- Proficient in ISO 13485, GDP, GMP
- A good understanding of of engineering and quality practices and methods
- Lean Six Sigma training (desirable but not essential)
- Excellent communication skills and attention to detail
- Strong leadership and mentoring behaviours
- Proficient in all Microsoft Office packages
What You'll Get
- Competitive Salary in accordance with experience and capabilities
- Pension
- Company performance bonus (paid annually)
- 33 days Holiday per year (incl Bank Holidays) plus Holiday Trading Scheme
- 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.
Applications close on Friday 4th October 2024
