Quality Engineer II, Medical Devices — Impact & Compliance

Johnson & Johnson Innovation; Santa Clara (CA); On-site; USD 105,000 - 115,000; Full time

Job summary

Johnson & Johnson is seeking a Quality Engineer II in Santa Clara, CA to develop, apply, and maintain quality standards for processing materials into finished products. You will design and implement inspection, testing, and evaluation procedures and support cross-functional teams to resolve technical problems.

The role requires a Bachelor's degree in Bioengineering or Biomedical Engineering and 2 years of related experience, plus experience with non-conformance investigations, risk management,

Qualifications

• Bachelor's degree in Bioengineering, Biomedical Engineering or related field and 2 years of experience in the job offered or in a Quality Engineer II-related occupation.
• Experience in: Medical device industry; Performing failure/ non-conformance investigations; Production line support including non-conformance investigation and product disposition, supporting process changes and process validation activities including IQ, OQ, and PQ; Technical writing for investigations, design and process verification and validation protocols and reports; Developing risk management documentation including plans, hazard assessment, design trace matrix development, DV&V testing, and FMEA; Conducting statistical analysis using Minitab or equivalent tools; ISO, ASTM, and FDA standards for quality within the medical device industry.

Responsibilities

• Develop, revise, and maintain quality standards for processing materials/products into partially or finished products.
• Design and implement methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products, components, sub-assemblies and/or production equipment.
• Support manufacturing and work cross-functionally to resolve technical problems.
• Participate in decisions on scope of work, risk management, design changes, process improvements, material disposition, and implementation of revised specifications.
• Process, investigate, and complete customer complaints.
• Prepare documentation for inspection/testing procedures, development studies, validation protocols and reports, quality plans, product defect investigations and inspection plans.
• Assess if components, sub-assemblies, and products meet specification and can initiate, investigate, and resolve non-conformances.
• Participate in developing the risk management documentation including (Hazard assessment, design trace matrix development, DV&V testing, and FMEA).
• Practice company safety, quality policies and procedures and participate in internal/external audits.

Skills

Quality Engineering

Medical device industry

Non-conformance investigations

Process validation

Statistical analysis

Technical writing

Risk management

Education

Bachelor's degree in Bioengineering / Biomedical Engineering

Tools

Minitab

Job description

Johnson & Johnson is seeking a Quality Engineer II in Santa Clara, CA to develop, apply, and maintain quality standards for processing materials into finished products. You will design and implement inspection, testing, and evaluation procedures and support cross-functional teams to resolve technical problems.

The role requires a Bachelor's degree in Bioengineering or Biomedical Engineering and 2 years of related experience, plus experience with non-conformance investigations, risk management,