Quality Engineer

Build a Career at SpiTrex CTEAt SpiTrex CTE, we invest in our people. You'll find opportunities to grow, real flexibility, and a culture that values balance, development, and teamwork.Why join CTE?Career Growth: Ongoing training and development through Bamboo Path Track & WorkForgeFlexibility: Flextime options that support real lifeCulture: Team events, Donut Fridays, food trucks, and moreRewards: Referral bonuses, quarterly bonuses, and a 401(k) with 50% company match (up to 10%)Benefits: No-cost vision, life, and short-term disability; dental & medical with HSA or PPO optionsReady to grow with a company that values you? Join SpiTrex CTE.1st Shift: Monday to Thursday, 6AM - 3PM; Friday, 6AM - 10AMEssential Functions:Assisting with Customer Audits, Internal Audits, Notified Body Audits, and FDA InspectionsAssisting with Supplier Management (including but not limited to supplier performance review, and supplier audits)Managing Direct ReportsDeveloping and implementing quality control procedures and guidelinesMonitoring and analyzing data to identify areas for improvementInitiate quality improvement projectsCollaborate with cross-functional teams to resolve quality issuesConducting audits on products and processesProviding guidance to other team membersInvestigating and resolving customer complaintsConform to ISO13485, 21 CFR Part 820, and medical device industry requirementsReviewing and approving product and process changesDeveloping procedures and work instructions as neededOther work-related tasks as assignedCompetency:Strong background in quality control and quality engineering functionsUnderstanding GD&TExperience with Statistical SoftwareExperience with Gage Repeatability and ReproducibilityExcellent communication skillsExcellent leadership skillsDetail-orientedStrong analytical and problem-solving skillsAbility to manage multiple projects simultaneouslyStrong understanding of medical device regulationsEducational Requirements:B.S. in Engineering field preferred or minimum of 5 years in Quality Engineering roleExperience:5-7 years of Medical Device experience in Quality setting preferredBenefits Include:Medical, Vision and Dental InsuranceShort-Term DisabilityLife Insurance401(k) - 50% company match (up to 10% contribution)Paid vacation daysPaid holidays