Senior Quality Engineer

Reprotech; Indianapolis (IN); Hybrid; USD 110,000 - 140,000; Full time

Job summary

TMRW, part of the Reprotech family, is seeking a Senior Quality Engineer to lead quality-system processes across the product lifecycle. You will administer document control, CAPA, change control, supplier quality, and eQMS/PLM workflows, supporting audits, risk assessments, and product development.

The role requires a Bachelor's in science/engineering and at least five years in medical device quality, familiarity with FDA QSR and ISO 13485, with hybrid Indianapolis onsite work and up to 20%

Qualifications

• Bachelor's degree in science/engineering or related field.
• 5+ years quality engineering or quality systems experience in medical device industry.
• Experience managing quality system processes: CAPA, complaints, change control, audits.

Responsibilities

• Administer document control, including review, approval, release, obsolescence, and retention.
• Coordinate QMS training, track completion and overdue training.
• Facilitate FMEA and hazard analyses with Engineering/Tech.
• Provide quality engineering support for product development, design reviews, and validation.
• Support ECOs and manage change-control activities with risk assessment and approvals.
• Oversee product complaint handling, investigations, trend analysis, escalation, closure.
• Coordinate CAPA activities and effectiveness verification.
• Lead SCAR investigations with Supply Chain and Engineering.
• Maintain Propel eQMS/PLM workflows and user support.
• Review and approve TSBs within quality authority.
• Support MRB activities with risk assessments and corrective actions.
• Assist internal and external audits and regulatory inspections.

Skills

CAPA management

FMEA

Document control

Audits

eQMS knowledge

Regulatory awareness

Education

B.S. in science/engineering

Tools

Propel eQMS

Job description

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.

Requirements

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.