Sr. Quality Engineer

Job Description Location: Alachua, FL You could be just the right applicant for this job Read all associated information and make sure to apply.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. Read more about this change and Evergen’s commitment to advancing regenerative medicine here: RESPONSIBILITIESServes as a lead core team member of cross functional project teams whose responsibilities include coordinating deliverables for the improvement of processes across the manufacturing facilitySupervises the Quality Assurance Engineering team including performance management, corrective action, hiring and selection, and allocation of engineering support as it relates to quality assurance initiativesReviews quality Key Performance Indicator (KPI) data and actions to ensure continuous improvement in collaboration with various operations value streamsReviews validations and risk management activities to support regulatory submissions, sustaining activities, and product launches are on time and have a high level of customer and patient focusLeads and conducts problem solving through change management, nonconformance workflows, and continuous improvement or new product development initiativesReviews and edits nonconformance investigation and disposition phases for team members and assists in the preparation and presentation of materials for quality initiativesOther duties as assignedREQUIREMENTSEducationBachelor’s degree in relevant technical disciplineExperience6+ years of relevant medical device, pharmaceutical, or other regulated industry experience.*Combination of advanced degree and experience may be considered. CertificationAATB or CTBS Certification, preferred Lead Auditor Certification, preferredASQ – CQE, CBA, or CQA, preferredSkills Excellent verbal and written communicationTechnical writingProblem solving methodologiesMicrosoft Office SuiteQuality Management System softwareInvestigationsStatistical techniquesTravel N/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. xaygatp 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.#LI-Onsite