Sr Quality Engineer (Hardware/Software) - Shockwave Medical Job at J&J Family of

J&J Family of Companies - Sr Quality Engineer (Hardware/Software) - Shockwave Medical Cheyenne, Wyoming

Johnson & Johnson is recruiting for a Sr Quality Engineer (Hardware/Software) for Shockwave Medical Inc. located in United States.

Position Overview:

The Sr. Quality Engineer will support manufacturing and work cross-functionally to resolve technical problems. Participates in decisions on scope of work, risk management, design changes, process improvements, material disposition, and implementation of revised specifications. Provides and develops solutions to broad problems, accomplishes complex assignments, develops protocols for design, and/or process activities, (including those related to verification or validation activities), determines criteria and subsequently generates summary (or final) reports.

Essential Job Functions:

1. Responsible for developing, applying, revising and maintaining quality standards for processing materials/products into partially or finished products.
2. Designs and implements methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products, components, sub-assemblies and/or production equipment.
3. Prepares documentation for inspection/testing procedures, development studies, validation protocols and reports, quality plans, and product defect investigations.
4. Provides guidance to manufacturing and development engineers regarding documentation, process controls, data feedback systems, and best quality practices.
5. Independently performs most assignments with an understanding of the overall expectations.
6. Plans, schedules, conducts, and coordinates detailed phases of engineering work in part of a major project.
7. Independently assesses if components, sub-assemblies, products meet specification and can initiate, investigate and resolve non-conformances by working in conjunction with a multidisciplinary team.
8. Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
9. May participate in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
10. May conduct internal and supplier audits. Certified as a lead auditor in ISO13485:2016 would be an asset.
11. Processing, investigating, and completing customer complaints, which could require direct email responses to customers.
12. Responsible for developing and maintaining calibration requirements for tools and equipment in the R&D, Manufacturing, and Quality areas.
13. Knowledge of statistics and Minitab, including process capability and data normality assessments, analysis of variance, 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 would be a great asset.
14. Other duties as assigned.

Qualifications

Requirements:

• BS in a related engineering discipline and 5+ years of related experience; or MS in a related engineering discipline and 3+ years of related experience
• Experience in the medical device industry is highly preferred
• Strong technical writing skills are required
• Must be proactive, self-motivated, and work independently with minimal supervision
• Must be willing to travel up to 10% of the time
• Effective communication skills with all levels of management and organizations
• Ability to work in a fast-paced environment, managing multiple priorities

The anticipated base pay range for this position is $89,000 to $142,600. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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