Senior Quality Engineer

TMRW, part of the Reprotech family of companies, develops technology and systems that support the safe identification, management, storage, and handling of reproductive cells. TMRW's mission is centered on reducing risk and improving quality within fertility care.

Position Summary

The Senior Quality Engineer is a high-level individual contributor responsible for administering and improving TMRW quality-system processes and providing quality engineering support throughout the product lifecycle. The role manages controlled documents, QMS training, complaints, CAPA, change control, supplier corrective actions, and Propel eQMS/PLM workflows; facilitates product and process risk assessments; and supports product development, engineering changes, audits, and management review. This position works cross-functionally with Engineering, Technology, Supply Chain, Field Service, the Technical Operations Center (TOC), and other departments.

Key Duties & Responsibilities

• Administer document control process, including review, approval, revision, release, obsolescence, and record retention.
• Coordinate QMS training, including assignments, completion tracking, training records, and overdue training follow-up.
• Facilitate FMEAs, hazard analyses, and associated risk-management documentation with Engineering and Technology.
• Provide quality engineering support for product development, design reviews, verification and validation, and product or process changes.
• Support Engineering Change Orders (ECOs) and coordinate change-control activities, including assessment of quality system and product risk impacts, documentation, approvals, and implementation.
• Coordinate product complaint handling, including investigations, documentation, trend analysis, escalation, and closure.
• Coordinate CAPA activities, including root cause investigations, corrective actions, implementation, and effectiveness verification.
• Coordinate Supplier Corrective Action Request (SCAR) investigations, corrective action follow-up, and effectiveness verification in collaboration with Supply Chain and Engineering.
• Administer and maintain Propel eQMS/PLM workflows, records, user support, and system improvements.
• Review and approve Technical Service Bulletins (TSBs) within assigned quality authority.
• Provide quality engineering support for Material Review Board (MRB) activities, including risk assessments, investigations, and corrective actions as needed.
• Conduct internal audits and support external audits and regulatory inspections, including preparation, responses, and corrective action follow-up.
• Develop and maintain quality plans for products, projects, and process improvements.
• Prepare and coordinate management review activities, including quality metrics, trend analysis, meeting materials, and action-item follow-up.
• Provide additional quality support and participate in cross-functional initiatives as assigned.

Education/Experience

• Bachelor's degree in science, engineering, quality, or a related technical field, or an equivalent combination of education and relevant experience.
• Minimum of five years of progressively responsible quality engineering or quality systems experience in the medical device industry.
• Demonstrated experience independently managing quality system processes, including CAPA, complaint handling, change control, document control, and audits.
• Experience with electronic Quality Management Systems (eQMS) and cross-functional quality activities.
• Knowledge of applicable FDA quality system requirements and ISO 13485.
• Experience with product risk management, FMEA, hazard analysis, design controls, engineering change management, and product development support is preferred.
• Familiarity with ISO 14971 and experience with Propel eQMS/PLM are preferred.

Work Environment and Physical Requirements

• Hybrid position based in Indianapolis, with regular onsite presence as required for collaboration and quality activities.
• Occasional travel of up to 20%.
• Work is primarily performed in an office environment, with occasional presence in product development, inspection, warehouse, or controlled storage areas.
• Appropriate personal protective equipment and adherence to applicable safety procedures are required in designated operational areas.

Reasonable accommodation may be given to qualified individuals with disabilities to perform the essential functions of the job.