R&D Quality Engineer - Medical Devices & Pharma

Stark Pharma Solutions Inc; Minneapolis (MN); On-site; USD 85,000 - 110,000; Full time

Job summary

Stark Pharma Solutions Inc in Minnesota is seeking an R&D Quality Engineer to support product development and ensure compliance with quality and regulatory requirements across R&D, manufacturing, and QA teams.

The role involves reviewing design docs, supporting DV/PV, risk management, CAPA, and audits, with emphasis on FDA, ISO 13485, GMP, and QMS alignment. Collaborative cross-functional work to drive product excellence.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or related field.
• 3–5 years in R&D Quality, Design Quality, Product Development Quality, or a similar role.
• Experience in Medical Device, Pharmaceutical, or Life Sciences industries.
• Knowledge of FDA regulations, ISO 13485, GMP, and Quality Management Systems (QMS).
• Experience with Risk Management, CAPA, NCR, Change Control, and Design Controls.

Responsibilities

• Support new product development (NPD) and design/development activities from a quality perspective.
• Review and approve design documentation, specifications, drawings, and technical requirements.
• Support Design Verification (DV) and Design Validation (PV) activities.
• Develop and review risk management documentation, including FMEA and risk assessments.
• Support CAPA, NCR, deviations, and change control processes.
• Ensure compliance with FDA, ISO 13485, and applicable GMP/quality standards, including 21 CFR Part 820 / QMSR requirements.
• Participate in design reviews and provide quality input to R&D projects.

Skills

FDA regulations

ISO 13485

Quality systems

Risk management

Document control

CAPA

Education

Bachelor's degree in Engineering

Job description

Stark Pharma Solutions Inc in Minnesota is seeking an R&D Quality Engineer to support product development and ensure compliance with quality and regulatory requirements across R&D, manufacturing, and QA teams.

The role involves reviewing design docs, supporting DV/PV, risk management, CAPA, and audits, with emphasis on FDA, ISO 13485, GMP, and QMS alignment. Collaborative cross-functional work to drive product excellence.