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Sr Quality Engineer.US-LAF.001

Integra LifeSciences
Lafayette, IN
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

Position SummaryIn collaboration with other Quality team members, the Sr. Quality Engineer will control, implement, and maintain the Medical Device Quality System and Quality Procedures in accordance with ISO 13485, FDA QSR, MDSAP, MDD, MDR, CE, FQS, and cGMP.Essential FunctionsDevelop, execute, and analyze quality-reporting measuresReport to management on quality issues, trends, and lossesServe as a resource to internal departments for problem identification and resolutionRepresent Quality in design development and manufacturing projectsDesign and implement methods for process control, process improvement, testing, and inspectionFacilitate and/or support a variety of validation efforts (design, equipment, software, process, TMV, CSV, etc.)Author, review, and approve Quality documents (SOPs, work instructions, protocols, reports, etc.)Additional ResponsibilitiesSupport Corrective and Preventive Actions (CAPA) systemParticipate in internal and external quality auditsConduct trend analysis of non-conformances and other quality indicators as needed

Required Education and ExperienceB.S. degree in a scientific discipline (Chemistry, Biology, Physics, Bio-Medical Engineering/Chemical Engineering, etc.)Minimum of 5-7 years of quality engineering experience in the biomedical industry, preferably in medical devicesMaster's degree, CQE, CQA, Six Sigma Black/Green belt are highly preferredWell-versed in 21 CFR part 820, EU MDD, MDR, and ISO 13485; understanding of ISO 14971, ISO 10993, 21 CFR part 11, and EU Annex 11 are highly preferred.Experience in applying statistical methods for quality sampling plans, and improvementsExperience in design control and process or software validation, root cause analysis, corrective and preventive action (CAPA) Required Knowledge, Skills, and AbilitiesComputer literacy-experience with Microsoft Teams, Excel, PowerPoint, Word, and Project. Minitab or other analytics software.Management and/or interaction with multilevel staffExcellent organizational skills; organized file managementStrong communication skills, both written and verbalProfessional, assertive demeanorKnowledge in supplier quality engineering and project management is beneficialTravel Requirement15% or lessPhysical RequirementsAble to communicate by phoneAble to use computer (use keyboard and mouse, view monitor) for most of work dayAbility to commute to work locationIn an effort to minimize the spread of the coronavirus and to protect our employees, all new hires in the US and Puerto Rico will need to be fully vaccinated for COVID-19 in order to be considered for employment with Integra LifeSciences, unless eligible for an accommodation as provided by law.
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