Quality Specialist 2

Job Description

Job Description

Location : This is a hybrid role based in West Lafayette, IN.

RTI Surgical is now Evergen!

This rebranding reflects our strategic evolution as a leading CDMO in regenerative medicine and comes at the end of a significant year for the business, including the successful acquisitions of Cook Biotech in IN. and Collagen Solutions, MN. Our new brand identity emphasizes our unique positioning as the only CDMO offering a comprehensive portfolio of allograft and xenograft biomaterials at scale.

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

• Supports quality system compliance with the appropriate internal and external regulatory requirements and maintain awareness of the overall regulatory landscape.
• Collects, analyzes, and reports data elements to demonstrate conformity and maintains effectiveness of the quality management system with a high degree of accuracy.
• Leads audit and inspection preparation, resolution of audit and inspection findings, and coordinates with auditing groups and inspectors through all stages of the audits.
• Applies for and maintains the company’s quality management system licensure including registration and recertification to ensure all licenses stay current.
• Acts as a subject matter expert during internal and third-party audits for responsible processes.
• Plans all elements of audit planning, execution, closeout, and follow-up with a high level of customer service.
• Works closely with other functional areas with the use of investigational tools to determine the root cause of any audit-related nonconformity, ensures that audit responses address root causes, and ensures that corrective actions and preventative actions are implemented to facilitate the rapid, compliant introduction of new and improved products, processes, and systems.
• Facilitates the investigation process to ensure that root and potential causes are appropriate and implement effective actions to reduce the occurrence or recurrence of the nonconforming audit finding.
• Uses risk-based sampling plans to verify the effectiveness of corrective and preventive actions in audit files.
• Supports other organizations in the management of their audit findings and provide additional confidence that investigations are initiated and completed in a complete, concise, and timely manner; and that viable corrective actions are identified and implemented to address any non-conformances discovered during audit.
• Support NC / CAPA for the medical device quality system.
• Complete and contribute to change control activities including, create, process, monitor, and ensure accuracy in both format and content for all documents, change requests, technical documents, letters, and internal correspondence while ensuring all regulatory and compliance guidelines are met.
• Serve as a point of contact for end user support with questions related to the change control process and other Document Control functions.
• Report deviations and other potential problems to QA management in a timely manner.
• Contributes to the company process improvement initiatives that impact quality systems and works collaboratively with cross-functional stakeholders to ensure compliance of processes and procedures within the quality management system.
• Apply the understanding of job specific quality system processes to meet FDA Quality System Requirements and ISO 13485 in carrying out duties.
• Other duties as assigned.

REQUIREMENTS : Education

Experience

Skills

Travel

Safety : Physical Requirement

75%) stationary position (standing or sitting) while utilizing digital displays

75% fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)

Working Environment

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 :

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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