Quality Engineer II

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.

We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Supply Chain Engineering

Job Sub Function:
Quality Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Santa Clara, California, United States of America

Job Description:

Employer: Shockwave Medical Inc.

Job Title: Quality Engineer II

Job Code: A011.10374

Job Location: Santa Clara, CA

Job Type: Full-Time

Rate of Pay: $105,000 - $115,000 per year

Job Duties: Develop, apply, 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 by working in conjunction with a multidisciplinary team.

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.

Requirements: Employer will accept a 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.

Position requires experience in:

1.

Medical device industry;

2.

Performing failure/ Product Non-conformance investigations;

3.

Production line support including non-conformance investigation and product disposition, supporting process changes and process validation activities including IQ, OQ, and PQ;

4.

Technical writing skills ...