Associate R&D Quality Engineer

Associate R&D Quality Assurance Engineer

The Associate R&D Quality Assurance Engineer works within the Quality Department to support development project deliverables and contribute to R&D efforts from concept through production for disposable medical devices—including catheters, catheter-based delivery systems, and other disposable devices used across disciplines such as cardiology, neurology, and urology.
This position partners closely with cross-functional teams to ensure that new product designs, processes, and documentation meet the company’s objectives for quality, regulatory compliance, and customer satisfaction.

• Follow and enforce the Quality Management System, including applicable SOPs.

• Represent Quality on development teams to ensure compliance with internal and external quality and regulatory standards.

• Partner with R&D to establish and implement design controls based on risk management, customer requirements, and manufacturability.

• Develop and maintain Design History Files and Quality Plans for development projects.

• Contribute to risk management activities in accordance with ISO 14971.

• Review and provide input on design and manufacturing documentation—including specifications, drawings, and procedures—to ensure manufacturability and compliance.

• Develop and optimize inspection documentation, including inspection procedures, forms, and sampling plans.

• Perform inspections on manufactured products and support verification and validation testing activities.

• Assist with creation and execution of test protocols and documentation of results (design verification, validation, lot release, test method validation, etc.).

• Train technicians and inspectors as needed.

• Review and approve lot history records and quality documentation for accuracy and compliance.

• Participate in investigations, nonconformance reports, and corrective/preventive actions (CAPA).

• Support customer complaint investigations and returned product evaluations.

• Participate in supplier qualification and monitoring activities, including defining incoming inspection criteria.

• Assist in internal and external audits of the quality system.

• Apply systematic problem-solving and root cause analysis methods to resolve quality issues.

• Support the Quality Department as needed to achieve departmental and company goals.

• Maintain direct billing above 70%.

• Demonstrate understanding of design and development processes by leading and executing full project deliverables to meet customer expectations.

• Education:

  • Bachelor’s or Master’s degree in Engineering or a related technical field, or equivalent experience.

• Experience:

  • 0–2 years of experience in Quality or R&D Engineering within the medical device industry.

  • Familiarity with ISO and FDA Quality Systems preferred.

  • Experience with design controls and Design History File development desired.

• Certifications:

  • Green Belt Certification preferred.

• Understanding of ISO 13485, ISO 14971, and FDA 21 CFR Part 820 cGMP standards.

• Proficient in medical device testing, protocol development, and report writing.

• Knowledge of statistics and data analysis tools (e.g., SPC).

• Strong computer skills, including Microsoft Office Suite.

• Excellent analytical, organizational, and problem-solving abilities.

• Effective verbal and written communication skills.

• Strong attention to detail and ability to manage multiple priorities in a fast-paced environment.

Join a team dedicated to advancing innovative medical device solutions that improve patient outcomes. You’ll collaborate with experts across multiple disciplines, contribute to cutting-edge product development, and be part of a company that values quality, teamwork, and continuous improvement.

Medical Murray is an equal opportunity employer