Quality Systems Manager in Alachua, Florida at RTI Surgical Inc

Experience

5+ years of experience in a Quality or Regulatory Affairs3+ years of leadership experience0-3 years of experience managing quality systems that require compliance with FDA Part 1271, FDA Part 820, ISO 13485 or AATB StandardsAdditional experience may be considered in lieu of education requirement

Certification

AATB Certified Tissue Bank Specialist (CTBS), preferredProcess Improvement Methodology certification, preferred

Skills

Excellent verbal and written communicationQuality Management System (QMS) softwareMicrosoft Office Suite, advanced ExcelRisk ManagementProcess Improvement MethodologiesSampling Plans and Statistical techniquesData Analysis

Travel

Minimal travel required, may occasionally travel for professional development or to support company initiatives, such as for audit support

Safety:

Physical Requirement

Move 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 Environment

Onsite: Office environment with assigned workstationRemote 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 Evergen in 2020 and has supported the transformation of the company to its next level of potential.

#LI-Onsite