Quality Engineer II

Johnson & Johnson•Santa Clara, CA

13d•Onsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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.

Requirements

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.
Medical device industry experience.
Performing failure/ Product 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 skills 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 for process capability and data normality assessments, analysis of variance, and hypothesis testing, determining appropriate sample sizes, tolerance interval assessments for variable and attribute data, design of experiment (DOE), and variable and attribute sampling plan applications.
Knowledge of ISO, ASTM, and FDA standards for quality within the medical device industry.

Responsibilities

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.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year (varies by state)
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Medical insurance
Dental insurance
Vision insurance
Time off benefits