Design Quality Assurance Engineer

The next Design Quality Assurance Engineer is needed by a cutting-edge medical device firm that specialises in coagulation and hemostasis testing.

RESPONSIBILITIES:

• Provide data for quality metrics, as required to support the Management Reviews.
• Conduct audits of design history files and ensure adherence to design control procedures.
• Participate in design reviews at all phases of the product lifecycle process.
• Serve as Quality team member and work with staff to answer common Quality inquiries or aid in addressing complaints from customers and regulatory agencies.
• Partner with R&D to perform risk management activities including hazard identification, hazard analysis, FMEA, and risk mitigation consistent with ISO 14971.
• Work closely with the R&D and Operations teams to transfer design changes into manufacturing standard operating procedures.
• Review verification and validation design documentation, specifications, and test reports to ensure accuracy and completeness.

KNOWLEDGE AND SKILLS:

• Must have a “hands-on” approach and work effectively on cross-functional teams to establish and maintain appropriate processes pertaining to Quality.
• Knowledge of IEC 60601-1, IEC 62304 and IEC 62366
• Knowledge of CAPA, non-conforming product investigations, deviations, change control, training and document control, complaint investigation, field actions and risk assessments.
• ISO 13485:2016 and 21 CRF Part 820 experience
• Initiate, review and approve Document Change Orders and Engineering Change Orders.

EDUCATION AND EXPERIENCE:

• Minimum of 2 years’ experience in quality engineering role, and BA/BS degree in science, engineering or related technical field;
• Or 1 years’ experience in quality engineering role, and MA/MS or PhD degree in science, engineering or related technical field;
• Or 4 years’ experience in quality engineering role, and Associates degree in science, engineering or related technical field,
• Or Minimum of 6 years’ experience in quality engineering role.