What are the responsibilities and job description for the R&D Quality Engineer position at United Pharma?
About the job:
We are seeking an experienced R&D Quality Engineer to support the development of next-generation implantable medical devices in a fast-paced and highly regulated environment. This role will work closely with R&D, Quality, and Manufacturing teams to ensure products meet design, quality, and regulatory requirements throughout the development lifecycle.
Key Responsibilities:
• Develop, review, and execute Design Verification and Validation (DV&V) activities
• Author verification protocols, test plans, technical reports, and quality documentation
• Support design control activities and ensure compliance with regulatory requirements
• Collaborate with cross-functional teams to support product development and FDA submission activities
• Participate in risk management, issue resolution, and product quality assessments
• Review test data and ensure traceability between requirements, testing, and deliverables
• Support continuous improvement initiatives and quality system compliance.
Qualifications:
• Bachelor's degree in Mechanical, Biomedical, Electrical Engineering, or related discipline
• 4–5 years of experience in Medical Device Quality, R&D, Design Assurance, or Product Development
• Strong experience with Design Verification & Validation (DV&V)
• Experience writing and executing verification protocols and reports
• Knowledge of Design Controls, product development processes, and technical documentation
• Experience working within FDA and ISO-regulated environments
• Familiarity with ISO 13485, FDA 21 CFR Part 820, and Risk Management (ISO 14971)
• Strong communication, analytical, and problem-solving skills