Quality Engineer II (Medical Devices)

Location: Santa Clara, California, United States of America

Salary: $105,000–$115,000 per year

Company

Johnson & Johnson MedTech, with hirify.global as the stated employer, develops healthcare and medical device solutions.

What you will do

• Develop, apply, revise, and maintain quality standards for materials, components, sub-assemblies, and finished products.
• Design and implement inspection, testing, and evaluation methods for products and production equipment.
• Support manufacturing and work cross-functionally to resolve technical problems, process issues, and non-conformances.
• Participate in risk management, design changes, process improvements, material disposition, and specification revisions.
• Investigate customer complaints, product defects, and non-conformances, and prepare related technical documentation.
• Support internal and external audits and maintain inspection, validation, quality plan, and investigation records.

Requirements

• Bachelor’s degree in Bioengineering, Biomedical Engineering, or a related field.
• At least 2 years of experience in the offered role or a related Quality Engineer II position.
• Experience in the medical device industry and failure or product non-conformance investigations.
• Experience supporting production lines, product disposition, process changes, and IQ, OQ, and PQ validation activities.
• Experience developing technical writing, risk management documentation, hazard assessments, design trace matrices, DV&V testing, and FMEA.
• Knowledge of Minitab or equivalent statistical tools, ISO and ASTM standards, and FDA quality requirements for medical devices.

Culture & Benefits

• Full-time employment with medical, dental, and vision benefits.
• Eligibility for pension, 401(k), and long-term incentive programs.
• Vacation, sick time, holiday pay, personal and family time, parental leave, caregiver leave, bereavement leave, volunteer leave, and military spouse time off.
• Inclusive workplace and interview accommodations for applicants with disabilities.