Sr. Quality Engineer

Build Your Career. Make an Impact. Join Evergen!

Are you passionate about quality, innovation, and making a difference? At Evergen, we're looking for an experienced quality professional who thrives on solving challenges, collaborating with talented teams, and driving meaningful improvements.

If you're someone who enjoys taking ownership, finding solutions, and ensuring the highest standards of quality, this could be the opportunity you've been looking for!

Who We Are

Evergen is a global, industry-leading Contract Development and Manufacturing Organization (CDMO) specializing in regenerative medicine. As the only regenerative medicine company offering a differentiated portfolio of allograft and xenograft biomaterials at scale, we are committed to advancing innovative solutions that make a meaningful difference.

Headquartered in Alachua, Florida, Evergen operates manufacturing facilities in West Lafayette, Indiana; Eden Prairie and Glencoe, Minnesota; Neunkirchen, Germany; and Marton, New Zealand.

We are also proud to be Great Place to Work® Certified in 2026! This recognition reflects our commitment to building a workplace where employees feel valued, supported, and empowered to grow.

Why You'll Love Working at Evergen

We believe great people deserve great opportunities. When you join Evergen, you're joining a collaborative, innovative organization where your contributions matter.

Our comprehensive benefits package includes:

• Generous Paid Time Off (PTO)

• 401(k) with company match

• Paid holidays

• Medical, dental, and vision insurance

• Short-term and long-term disability coverage

• Paid parental leave

• And much more!

Beyond our benefits, you'll have the opportunity to work alongside talented professionals, contribute to meaningful projects, and grow your career in an organization committed to quality, innovation, and continuous improvement.

About the Opportunity

We're looking for a quality professional who brings technical expertise, a collaborative mindset, and a passion for continuous improvement. In this role, you'll be an important partner to our cross-functional teams, helping ensure our products, processes, and quality systems meet the highest standards. From supporting product development and leading investigations to partnering with suppliers and driving process improvements, your work will play a critical role in supporting our commitment to quality and patient safety. If you enjoy variety in your work, tackling complex challenges, and seeing the impact of your contributions, you'll feel right at home on our team!

What You'll Do

Champion Quality & Continuous Improvement

• Build strong relationships with cross-functional partners to support business objectives, align priorities, and strengthen quality processes.

• Identify opportunities to improve quality systems, enhance operational efficiency, and support continuous improvement initiatives.

• Serve as a trusted quality partner, providing technical expertise and supporting effective decision-making.

Support Product Development & Risk Management

• Collaborate with product development teams to review and approve design deliverables, ensuring quality is incorporated throughout the development process.

• Participate in risk assessments, product evaluations, and the review and disposition of nonconforming products, including customer complaints.

• Support validation activities through the review and approval of validation protocols and reports.

• Apply appropriate sampling plans and statistical techniques to support data-driven quality decisions.

Lead Investigations & Drive Solutions

• Lead investigations into product nonconformances and process compliance issues, identifying root causes and developing effective corrective and preventive actions (CAPA).

• Apply sound judgment and proven problem-solving techniques to resolve complex quality challenges.

• Manage CAPA activities, including investigations, product and process disposition, risk management, and effectiveness checks.

• Help implement sustainable solutions that strengthen product quality and process reliability.

Partner with Suppliers & Support Compliance

• Support supplier qualification activities, including supplier assessments, audits, corrective actions, and ongoing risk evaluations.

• Collaborate with suppliers and internal stakeholders to address quality concerns and drive improvements.

• Participate in internal and external audits to support regulatory compliance and quality system effectiveness.

• Ensure effective change control by initiating change plans, updating procedures and work instructions, and reviewing and approving documentation.

• Perform other duties as assigned.

What You'll Bring to the Team

Education & Experience

• Bachelor's degree in Engineering or a related technical discipline.

• Minimum of 6 years of experience in quality or engineering.

• Relevant experience may be considered in place of educational requirements.

Skills & Qualifications

• Strong written and verbal communication skills, with the ability to build relationships and collaborate across departments.

• Excellent problem-solving skills and experience conducting investigations and root cause analysis.

• Strong technical writing skills with exceptional attention to detail.

• Experience working with Quality Management Systems (QMS) and related software.

• Proficiency in Microsoft Office Suite.

• Ability to prioritize multiple projects, exercise sound judgment, and work effectively in a team-oriented environment.

Work Environment & Physical Requirements

Work Environment

• Onsite positions: Professional office environment with an assigned workstation.

• Remote positions, where applicable: Home office environment with minimal distractions.

• Travel: Not required.

Physical Requirements

• Ability to move or lift objects weighing up to 25 pounds.

• Frequent (greater than 75%) stationary positioning, including standing or sitting while utilizing digital displays.

• Frequent (greater than 75%) fine motor activities, including typing, writing, clicking, and handling documents.

Our Culture: Built on Values That Matter

At Evergen, our values guide how we work, collaborate, and grow together.

• Accountable: We take ownership of our actions and decisions.

• Agile: We embrace change, innovation, and new opportunities.

• Growth Mindset: We view challenges as opportunities to learn, improve, and grow.

• Customer-Centric: We put our customers at the center of everything we do.

• Inclusive: We celebrate diverse perspectives and create an environment where everyone feels respected and valued.

We're committed to fostering a workplace where employees can bring their authentic selves to work, share ideas, and contribute to something bigger.

More About Evergen

Evergen partners with customers across diverse market segments, providing expertise, scale, and flexibility through end-to-end services, including design, development, regulatory support, verification and validation, manufacturing, and supply chain management.

Our commitment to quality, integrity, and patient safety drives everything we do as we work toward becoming the CDMO of Choice in regenerative medicine.

Evergen's continued growth and transformation have been supported by Montagu Private Equity, a leading European private equity firm that acquired RTI in 2020.

Learn more about Evergen and follow our journey on LinkedIn:

https://www.linkedin.com/company/evergenbio