R&D Quality Engineer

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

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Job Title: R&D Quality Engineer

Location: Minnesota

Duration: Long Term

Job Summary

We are looking for an R&D Quality Engineer to support product development and engineering teams in ensuring products meet quality, regulatory, and design requirements. The role will work closely with R&D, Manufacturing, Regulatory, and Quality teams throughout the product development lifecycle.

Key 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.
• Support process validation and equipment qualification activities when required.
• Conduct root-cause analysis using tools such as 5 Why, Fishbone, and FMEA, along with Lean/Six Sigma and statistical quality tools when applicable.
• Prepare and maintain quality documentation in accordance with company procedures, including Design History File (DHF) and Device Master Record (DMR) documentation.
• Work with cross-functional teams to identify and resolve quality issues.
• Support internal and external audits and regulatory inspections.
• Support design control activities throughout the product development lifecycle.
• Work with Design Verification and Design Validation documentation and activities.
• Utilize or support quality management systems and platforms such as Veeva, TrackWise, MasterControl, SAP, or similar QMS platforms.

Basic 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.
• Experience with Lean/Six Sigma or statistical quality tools is beneficial.
• Familiarity with systems such as Veeva, TrackWise, MasterControl, SAP, or similar QMS platforms.
• Strong documentation, analytical, problem-solving, and communication skills.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.