Quality Engineer

Quality Assurance ManagerLocation: West Lafayette, INSalary: $100,000 to $120,000Annual Bonus eligibility: $10,000Relocation bonus offered!Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN, Eden Prairie and Glencoe, MN, Neunkirchen, DE, Glasgow, UK, and Marton, NZ.RESPONSIBILITIESDevelops strong network of cross-functional colleagues, a deep understanding of business goals, project prioritization, and strong communication and facilitation skills to support the Quality Assurance function.Supports product development processes inclusive of review and approval of design project deliverables, collaboration with core teams, and review and approval of risk management deliverablesLeads investigations for product nonconformances, process noncompliance issues, documents these appropriately in the Corrective Action / Preventive Action (CAPA) system, and demonstrates good judgment in selecting methods and techniques for obtaining solutionsParticipates in risk assessment, review, and disposition of nonconforming products including complaintsPerforms CAPA activities inclusive of root cause analysis, investigations, product and process disposition, risk management, and effectiveness checkSupports supplier qualification activities inclusive of completing and maintaining supplier qualifications, working with suppliers to address corrective actions, performing supplier audits, and assessing supplier riskSupports validation activities inclusive of reviewing and approving validation protocols and reportsInterprets and applies appropriate sampling plans and statistical techniquesEnsures proper change control including initiating change plans, updating Work Instructions and Standard Operating Procedures, and documentation approvalsDirectly supports the quality systems and process improvement initiativesSupports and performs internal and external auditsOther duties as assignedREQUIREMENTSEducationBachelor's degree in Engineering or relevant technical disciplineExperienceMinimum of 6 years of quality or engineering experience required. Experience may be substituted for education requirements.SkillsExcellent verbal and written communicationTechnical writingProblem solving methodologiesMicrosoft Office SuiteQuality Management System softwareInvestigationsTravelN/ASAFETYPhysical RequirementMove or lift objects up to 25 poundsFrequent (>75%) stationary position (standing or sitting) while utilizing digital displaysFrequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)Working EnvironmentOnsite: Office environment with assigned workstationRemote positions only: Home office environment with minimum distractionsMore about Evergen:Evergen provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management.Evergen is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values:Accountable: We own our actions and decisions.Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth.Growth Mindset: We embrace challenges as opportunities for continuous learning.Customer-Centric: We prioritize customers at every touch point.Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated.At Evergen, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success.Montagu Private Equity ("Montagu"), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential.