Medical Device Quality Assurance Engineer - 58386 - PRIMUS Global Services, Inc

We have an immediate opportunity with one of our key clients for a position of Medical Device Quality Assurance Engineer, to work in Pleasanton, CA.

Pay Rate: $30 - $35/hr on C2C

Responsibilities:

• Accountable for decision-making and oversight of quality systems, including CAPA, ICS, and product RFA.
• Develop and maintain procedures and forms for CAPA, product RFA, and ICS systems in collaboration with key stakeholders.
• Review and approve validation protocols/reports (IQ, OQ, PQ), Test Method Validation, and Inspection Method Validation protocols/reports.
• Ensure that all quality assurance processes comply with industry regulations and company standards.
• Lead detailed data analysis, trending, and reporting for CAPA, ICS, and RFA.
• Publish and communicate weekly, monthly, and quarterly metrics to relevant stakeholders.
• Participate in or lead the completion of risk assessments, including Process Failure Modes and Effects Analysis (PFMEA).
• Identify and mitigate potential risks to ensure the safety and efficacy of medical devices.
• Track manufacturing-related complaints in alignment with company goals and ensure timely resolution.
• Support the Global CAPA team with training, oversight, and deliverables to maintain a robust CAPA system.

Required Skills & Qualifications:

• 4 to 6 years of experience in quality assurance within the medical device industry, with a strong manufacturing background.
• Experience in reviewing and approving validation protocols/reports (IQ, OQ, PQ), Test Method Validation, and Inspection Method Validation.
• Strong understanding of quality systems, including CAPA, ICS, and RFA.
• Proficiency in data analysis, trending, and reporting for quality systems.
• Ability to lead and participate in risk assessments and other quality assurance activities.
• Strong problem-solving skills to identify and resolve quality issues in a timely manner.

For immediate consideration, please contact:

Suryansh
PRIMUS Global Services
Phone No: 972-753-6500 Ext: 261
Desk: 972-829-4883
Email: jobs@primusglobal.com