Sr. Quality Engineer

Salary: $100,000 to $120,000

Annual Bonus eligibility: $10,000

Relocation 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.  

Read more about this change and Evergen’s commitment to advancing regenerative medicine here: https://lnkd.in/eMSfVJkM ;      

RESPONSIBILITIES

• Develops 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 deliverables
• Leads 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 solutions
• Participates in risk assessment, review, and disposition of nonconforming products including complaints
• Performs CAPA activities inclusive of root cause analysis, investigations, product and process disposition, risk management, and effectiveness check
• Supports supplier qualification activities inclusive of completing and maintaining supplier qualifications, working with suppliers to address corrective actions, performing supplier audits, and assessing supplier risk
• Supports validation activities inclusive of reviewing and approving validation protocols and reports
• Interprets and applies appropriate sampling plans and statistical techniques
• Ensures proper change control including initiating change plans, updating Work Instructions and Standard Operating Procedures, and documentation approvals
• Directly supports the quality systems and process improvement initiatives
• Supports and performs internal and external audits
• Other duties as assigned

REQUIREMENTS

Education

Experience

Skills 

• Excellent verbal and written communication
• Technical writing
• Problem solving methodologies
• Microsoft Office Suite
• Quality Management System software
• Investigations

Travel 

SAFETY

Physical Requirement

• Move or lift objects up to 25 pounds
• Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
• Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)

Working Environment

• Onsite: Office environment with assigned workstation
• Remote positions only: Home office environment with minimum distractions

More 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.

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