Quality Engineer

Quality Assurance EngineerActs as the primary advocate for compliance and Quality Assurance Engineering of medical devices and medical device components for the development of Validation programs and program compliance requirements such as Quality Plans, pFMEAs, and process control plans with the goal of facilitating product safety and compliance, of consistently meeting/exceeding customer's expectations and following and upholding TriMas Life Sciences principles thru-out the product life cycle.Top accountabilities (no more than 3): Development of IQ/OQ and PQ protocols and summary reports Strong Risk Assessment support to the client, groups within the organization and supplier-base Perform Risk Analysis in accordance with ISO-14971 and FMEA principles Quality Plans - layouts, sampling plan, and control dimensions for release per VoC-requirements Help the organization discern client pharma or device phase of development and assess device application Coordinate quality efforts with client for customer specific quality requirements Share best practices concerning the quality control of the productAuthority: Validation protocol approval Completion and approval of risk assessments support NCRs, CCRs and SCCs Performance of internal audits and citing nonconformancesSpecific Responsibilities:Uphold and communicate the purpose, principles, and vision of TriMas Life SciencesFacilitates Validation activities such client negotiations and technical writing of:Validation PlansValidation Protocol Issue Resolution Reports- initiates appropriate corrective actionValidation Reports for submission to clientsStrong Risk Assessment support to the client, groups within the organization and supplier-basePerform Risk Analysis in accordance with ISO-14971 and FMEA principles.Quality Plans - layouts, sampling plan, and control dimensions for release per VoC-requirementsHelp the organization discern client pharma or device phase of development and assess device applicationAccess FDA pharma and medical device web site for up-to-date requirementsCoordinate quality efforts with client for customer specific quality requirementsShare best practices concerning the quality control of the productPerformance of internal audits which includes performing assessments for compliance to 21 CFR 820 and ISO 13485:2016 standardsSupport controlled quality runs for IQ, OQ and PQ activitiesEnsures all documentation is managed properly - forms are filled out and records properly storedProduct is properly identified while updating - includes change management back thru client approvalsManages process changes to quality plan, metrology methods and other related documentsSupport the Corrective/Preventive action system through the identification, containment, investigation and resolution of NCRs.Participates and support third party and client site audits as neededContinually seeks out new ways to improve Omega Plastics quality processes to support our operationsOther tasks as assigned by immediate supervisor and/or manager.TriMas Life Sciences is a global provider of precision injection-molded components and assemblies for the medical device, diagnostic, pharmaceutical and surgical markets. The company serves key industries, including medical, packaging, industrial and consumer goods, and through our trusted brands, we deliver innovative, high-quality solutions that support our customers from prototype to full-scale production.Our work enables life-saving technologies and products that improve people's lives, and we take pride in being part of that purpose every day.At TriMas Life Sciences, we believe our success begins with our people. We are committed to creating an environment where every employee feels valued, supported and inspired to contribute their best work.When you join our team, you become part of a collaborative and purpose-driven organization committed to: Supporting Our People – Our employees are the heart of our success. We embrace diversity, encourage collaboration and foster an inclusive workplace built on safety, respect and continuous learning. Driving Innovation – We invest in technology, automation and process excellence to deliver "part perfect" solutions. Our teams are empowered to develop new ideas while ensuring the highest standards of quality and compliance. Advancing Healthcare – We partner with our customers to design and manufacture precision-engineered solutions that enable medical innovation, enhance patient care and support better health outcomes worldwide. Building a Sustainable Future – We are committed to responsible manufacturing, minimizing environmental impact and helping customers bring safer, more sustainable products to market.We offer competitive benefits, a culture that supports and empowers our people, and opportunities to make a meaningful difference.If you're looking for a place where you can grow your career, be challenged and contribute to life-changing innovations, TriMas Life Sciences is the place for you.