Sr. Quality Engineer

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
• Led 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

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
• Statistical techniques

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, Agile, Growth Mindset, Customer-Centric, and Inclusive. 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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