Senior Medical Device Quality Assurance Engineer | Hybrid

Radiant Systems Inc; Portage (MI); Híbrido; USD 48.000 - 58.000; Jornada completa

Descripción de la vacante

Major Medical Device Client in Portage, Michigan is seeking a Senior Manufacturing Quality Assurance Engineer for a 5-month hybrid engagement. The role requires supporting change control approvals, NC/CAPA guidance, and QE tasks with 3 days on-site minimum.

Ideal candidates have 2+ years in quality investigations, documentation reviews, and strong communication skills. Bachelor’s degree in Engineering is required. This position is W2 with pay rate $35.00-$42.00 per hour.

Formación

• 2+ years of good communication skills
• 2+ years documentation and print review experience
• 2+ years quality investigation experience

Responsabilidades

• Investigate product failures by reviewing design history, manufacturing records, and field performance data to identify root causes and improvement opportunities.
• Analyze and trend post-market product complaint data, delivering regular, data-driven insights to divisional quality leadership.
• Update risk management documentation to reflect post-market findings and product changes, ensuring continued product safety and effectiveness.
• Participate in cross-functional product improvement teams to define, prioritize, and execute corrective and preventive actions.
• Initiate, track, and document commercial product holds, ensuring timely resolution and accurate records.
• Support business units and commercial teams by providing post-market quality expertise and technical guidance.
• Facilitate and coordinate subject matter experts to develop technical documentation for product field action assessments and present findings to governance boards and senior leadership.
• Guide research and development teams through quality system requirements to ensure product changes comply with regulatory and quality standards.

Conocimientos

Communication skills

Documentation review

Quality investigation

Educación

Bachelor’s Degree in Engineering

Herramientas

TrackWise

Descripción del empleo

Major Medical Device Client in Portage, Michigan is seeking a Senior Manufacturing Quality Assurance Engineer for a 5-month hybrid engagement. The role requires supporting change control approvals, NC/CAPA guidance, and QE tasks with 3 days on-site minimum.

Ideal candidates have 2+ years in quality investigations, documentation reviews, and strong communication skills. Bachelor’s degree in Engineering is required. This position is W2 with pay rate $35.00-$42.00 per hour.