Senior Quality Engineer

Evergen; Town of Florida (NY); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

PTO

401(k) match

Holiday pay

Health insurance

Disability insurance

Parental leave

Job summary

Evergen, a global CDMO in regenerative medicine, seeks a senior QA leader to drive quality across manufacturing. You will supervise the QA Engineering team, coordinate cross-functional projects, and ensure timely regulatory submissions and product launches with a patient-centered focus.

The role requires a Bachelor’s degree in a technical field, 6+ years in a regulated industry, and certifications such as AATB/CTBS; Lead Auditor or ASQ credentials preferred.

Qualifications

• Bachelor’s degree in relevant technical discipline.
• 6+ years of relevant medical device, pharmaceutical, or other regulated industry experience.
• AATB or CTBS Certification preferred; Lead Auditor Certification, preferred; ASQ CQE/CBA/CQA preferred.
• Combination of advanced degree and experience may be considered.

Responsibilities

• Serves as a lead core team member of cross functional project teams coordinating deliverables for process improvements across the manufacturing facility.
• Supervises the QA Engineering team including performance management and allocation of engineering support for quality initiatives.
• Reviews KPI data and actions to ensure continuous improvement with operations value streams.
• Reviews validations and risk management activities to support regulatory submissions, sustaining activities, and product launches.
• Leads problem solving through change management, nonconformance workflows, and improvement initiatives.
• Reviews and edits nonconformance investigations and dispositions and aids in materials preparation for quality initiatives.

Skills

Communication

Technical writing

Problem solving

MS Office

Investigations

Cross-functional leadership

Education

Bachelor’s degree in relevant technical discipline

Tools

Quality Management Software

Job description

Annual Bonus Opportunity up to $10,000.00

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, Germany; Glasgow, UK; and Marton, New Zealand.

We are proud to be Great Place to Work® Certified in 2026, reflecting our commitment to creating an exceptional employee experience and workplace culture. Evergen currently has full-time career opportunities available across multiple locations.

• Paid Time Off (PTO)
• 401(k) with up to a 6% company match
• Holiday pay
• Medical, dental, and vision insurance
• Short-term and long-term disability coverage
• Paid parental leave and much more!

Read more about this change and Evergen’s commitment to advancing regenerative medicine here: https://www.linkedin.com/company/evergenbio

RESPONSIBILITIES

• Serves as a lead core team member of cross functional project teams whose responsibilities include coordinating deliverables for the improvement of processes across the manufacturing facility
• Supervises the Quality Assurance Engineering team including performance management, corrective action, hiring and selection, and allocation of engineering support as it relates to quality assurance initiatives
• Reviews quality Key Performance Indicator (KPI) data and actions to ensure continuous improvement in collaboration with various operations value streams
• Reviews 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 focus
• Leads and conducts problem solving through change management, nonconformance workflows, and continuous improvement or new product development initiatives
• Reviews and edits nonconformance investigation and disposition phases for team members and assists in the preparation and presentation of materials for quality initiatives
• Other duties as assigned

REQUIREMENTS

Education

• Bachelor’s degree in relevant technical discipline

Experience

• 6+ years of relevant medical device, pharmaceutical, or other regulated industry experience.
• *Combination of advanced degree and experience may be considered.

Certification

• AATB or CTBS Certification, preferred
• Lead Auditor Certification, preferred
• ASQ – CQE, CBA, or CQA, preferred

Skills

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

Travel

• N/A

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.)
• 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.