R&D Quality Engineer: Drive Regulated Medical Device Quality

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 experienced R&D Quality Engineer to support product development and engineering teams, ensuring products meet quality, regulatory, and design requirements.

You will collaborate with R&D, Manufacturing, Regulatory, and Quality to drive design controls, risk management, and design verification/validation throughout the product lifecycle, leveraging QMS tools such as Veeva, TrackWise, MasterControl, and SAP.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related field.
• 3-5 years of experience in R&D Quality, Design Quality, Product Development Quality, or a similar role.
• Experience working 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.
• Experience with Design History File (DHF), Device Master Record (DMR), and Design Verification/Validation.
• Knowledge of 21 CFR Part 820 / QMSR requirements.
• Familiarity with systems such as Veeva, TrackWise, MasterControl, SAP, or similar QMS platforms.
• Strong documentation, analytical, problem-solving, and communication skills.

Responsibilities

• Support NPD and design/development activities from a quality perspective.
• Review and approve design documentation, specifications, drawings, and technical requirements.
• Support DV and PV activities.
• Develop and review risk management documentation, including FMEA and risk assessments.
• Support CAPA, NCR, deviations, and change control processes.
• Ensure FDA, ISO 13485, GMP, and QMSR compliance.
• Participate in design reviews and provide quality input to R&D projects.
• Support process validation and equipment qualification activities when required.
• Conduct root-cause analysis using 5 Why, Fishbone, and FMEA, plus Lean/Six Sigma tools.
• Prepare and maintain quality documentation (DHF, DMR) per procedures.
• Work with cross-functional teams to identify and resolve quality issues.
• Support internal and external audits and regulatory inspections.
• Support design control activities throughout product lifecycle.
• Work with DV/Verification documentation and activities.
• Utilize or support quality management systems and platforms.

Skills

Strong documentation

Analytical skills

Problem-solving

Communication skills

Education

Bachelor's degree in Engineering, Quality, Life Sciences, or related field

Tools

Veeva

TrackWise

MasterControl

SAP

Job description

Stark Pharma Solutions Inc in Minnesota is seeking an experienced R&D Quality Engineer to support product development and engineering teams, ensuring products meet quality, regulatory, and design requirements.

You will collaborate with R&D, Manufacturing, Regulatory, and Quality to drive design controls, risk management, and design verification/validation throughout the product lifecycle, leveraging QMS tools such as Veeva, TrackWise, MasterControl, and SAP.