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Sr Quality Engineer, Private Label.US-BOS.001

Integra LifeSciences
South Boston, MA
Closing date
May 15, 2022

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Integra LifeSciences is a global leader in regenerative technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care. Founded in 1989, Integra develops, manufactures, sells and supplies best-in-class products to regenerate tissue, remove brain tumors, prevent infection and much more. And over the last three decades, we've evolved into one of the world's leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.But that's just the beginning. Integra is growing at an unprecedented rate. We're at a moment in time where the experience you'll gain is more robust than the experience you bring. And we're out to invest in your future because it's the best way to maximize ours. At Integra, we firmly believe our people are our greatest asset and the foundation of our success. Our comprehensive Global Total Rewards program provides competitive compensation and benefits designed to keep our people healthy, motivated and engaged. Investing in our people through these programs is possible because of Integra's ongoing commitment to our values and our shared success. Integra's health as a company begins with the well-being of our people. Benefit programs vary by country, whether provided through company-sponsored insurance and programs, through statutory government programs, or a combination of both. Regardless of geographic location, our commitment is to offer the following, whenever possible:Benefit plans that meet all local statutory requirementsA range of programs that reflect typical local market practicesAn opportunity for employees to tailor benefits to their specific needsBenefits that balance employee's short-term and long-term needsClick HERE for more information regarding our benefits and total rewards program

Provide Quality Engineering Support for Integra Private Label products, including audits/assessments, inspection technique support, verification /validation activities, CAPA/SCAR and change management. FDA CFR part 820 and ISO 13485 regulations/standards will be the focus.Establish and ensure Supplier Quality Agreements are up to date for Integra Private Label partnershipsReport on Private Label related manufacturer performance metrics as neededDevelops and maintains procedures and work instruction related to manufacturing and handling private label product.Takes part in change control process at site level to assess potential impact to private label productAddresses Change Requests and Change Notifications in compliance with procedures and regulatory requirementsAct as facilitator for Private Label partner audits, representing the Integra manufacturing site and QMSEnsures that Private Label related Non-conformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirementsEnsure technical support to QC, purchasing and production departmentsEscalate quality issues to management as appropriate, develop and propose robust and compliant solutionsMay conduct Internal and/or Supplier Audits as neededManages or participates in quality projects as requiredProvides support with complaint investigations as required

A minimum of a Bachelor's Degree in an Engineering, Life Science, or a related technical discipline is required. Candidates with an equivalent combination of education and experience will also be considered for the position.Experience working in a Medical Device manufacturing environment is strongly preferred. Operations quality experience in a clean room environment, with a strong understanding of process validation (IQ, OQ, PQ) highly desiredMinimum 5 years of professional work experience in a GMP and /or ISO regulated industry is requiredKnowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC, 21 CFR part 820Auditor Certification to ISO 13485:2016 is strongly preferredStrong communication, teamwork, and organizational skills are essentialStrong analytical problem solving and root cause analysis skillsUse of ERP, PLM systemsUse of Microsoft office toolsKnowledge of statistical techniquesExperience or knowledge with the tissue based medical devices and experience with collagen based manufacturing processes is highly preferred
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