Senior Engineer Advanced Quality

Become Part of the TeamWith 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 DoYou 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 approachInitiate and lead in the development of PHAs, pFMEAs, dFMEAsLead regular risk meetingsParticipate in monthly trending meetingsSite Process Owner design quality and risk managementOversight and lead risk management investigations for HHE, PFAs, NCs and CAPAsReview 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 managementSupport manufacturing and design transfers, leading quality activities.Support of ship, product Holds, potential product escapes from a risk perspectiveCoach 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 AreWe believe you're the right fit if you havePrevious experience in a regulated environmentProficient understanding of Medical Device manufacturing processesProficient in ISO 13485, GDP, GMPA good understanding of of engineering and quality practices and methodsLean Six Sigma training (desirable but not essential)Excellent communication skills and attention to detailStrong leadership and mentoring behavioursProficient in all Microsoft Office packagesWhat You'll GetCompetitive Salary in accordance with experience and capabilitiesPensionCompany performance bonus (paid annually)33 days Holiday per year (incl Bank Holidays) plus Holiday Trading SchemeBenefits 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