Senior Quality Engineer - Medical Devices | QMS & CAPA Lead

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, 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%