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Sr Supplier Quality Engineer.US-MAN.003

Employer
Integra LifeSciences
Location
Mansfield, MA
Closing date
Sep 19, 2021

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Sector
Other
Organization Type
Corporate
Overview:
Integra LifeSciencesis 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, weve evolved into one of the worlds leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.But thats just the beginning.Integra is growing at an unprecedented rate. Were at a moment in time where the experience youll gain is more robust than the experience you bring. And were out to invest in your future because its 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 Integras ongoing commitment to our values and our shared success.Integras 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 employees short-term and long-term needsClick HERE for more information regarding our benefits and total rewards program

Responsibilities:
Provides quality assurance leadership to select contract manufacturing sites and raw material suppliers engaged in the production of Integra productsEstablishes and ensures the Approved Supplier List is up to dateEstablishes timely planning and execution of supplier auditsConducts Supplier Audits according to good manufacturing practices, ISO Standards, and applicable regulatory requirementsEnsures comprehensive measurement systems in place to monitor supplier quality/reliability, and to identify, correct and prevent defectsEstablish and ensure Supplier Quality Agreements are up to date for applicable suppliers engaged in the production of Integra productsReport on contract manufacturer performance metricsEnsure technical support to QC, purchasing and production departmentsProvide Quality Engineering Support to suppliers including audits/assessments, inspection technique support, verification /validation activities, CAPA and change management. FDA CFR part 820 and ISO 13485 regulations/standards will be the focus.Addresses Supplier Change Requests in compliance with procedures and regulatory requirementsEnsures that activities for validation of outsourced processes/products are performed and documented according to procedures and within the defined timelineEnsures that Supplier Non-conformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirementsEscalate supplier quality issues to management as appropriate, develop and propose robust and compliant solutionsParticipates and supports internal and third party audits / inspectionsConducts internal audit as requiredManages or participates in quality projects as requiredProvides support with complaint investigations as required

Qualifications:
A minimum of a Bachelors 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 preferred.Operations supplier quality experience, with a strong understanding of process validation (IQ, OQ, PQ) highly desiredMinimum 3 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 820Strong communication, teamwork, and organizational skills are a mustStrong analytical problem solving and root cause analysis skillsAuditing background is preferredUse of ERP, PLM systemsUse of Microsoft office toolsKnowledge of statistical techniquesExperience or knowledge with the machining processes, injection molding, and/or electro-mechanical components/assembly is preferred

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