Senior Quality Engineer (Pittsburgh, PA)

Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.

The Senior Quality Engineer takes the lead in developing, implementing, and enhancing production monitoring methods and systems for inspecting and testing all new products. This person evaluates products, manufacturing processes, assembly processes, and supports quality control activities through training, inspection procedure preparation, and technical support.

What will you be doing?

• Coordinates design review meetings to review all quality aspects of new products. Works with Product Development Engineers to ensure quality considerations during the concept stage.
• Develop and implement methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed.
• Design and install sophisticated testing equipment and perform product testing and analysis to maintain quality levels and minimize defects and failure rates.
• Works with other Quality Engineers and the Metrology Lab personnel on the development of all product gaging.
• Collaborate with supplier representatives on quality problems, ensure that effective corrective actions are implemented, and contribute to supplier quality improvement programs.
• Works with suppliers, management, engineers, and manufacturing associates to resolve quality problems. Also, assists each of these groups with capability studies and the application of statistical quality control.
• Interfaces with Manufacturing Engineers to review processes for new products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.
• Validate manufacturing process, including activities associated with Installation Qualification (IQ), Operational Qualification (OQ),and Performance Qualification (PQ).
• Apply Lean Six Sigma concepts to eliminate waste, improve throughput, improve quality, and reduce cost.
• Assists with complaint investigation and documentation interfaces with Regulatory Affairs to support IEC, FDA and other applicable regulatory submissions.

What will you need to be successful?

• Bachelor of Science Degree in Mechanical, Manufacturing, Electrical, Biomedicalor Industrial Engineering required.
• BS and 5+ years within the medical device industry or electronic design in a regulated industry or
• MS and 3+ years within the medical device industry or electronic design in a regulated industry

• Working knowledge of statistical sampling, statistics, audit techniques, test method validation and the use of Minitab statistics software preferred.
• Experience using 3D modeling software to design gages/ fixtures and LabVIEW preferred.
• General knowledge of root cause analysis, process improvement and PPAP
• ASQ CQE preferred.

You Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

• Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/)
• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
• Flexibility: Hybrid Work Model (For most professional roles)
• Training: Hands-On, Team-Customized, Mentorship
• Extra Perks: Discounts on fitness clubs, travel and more!

Smith+Nephew is committed to the full inclusion of all qualified individuals. As part of this commitment, Smith+Nephew will ensure that persons with disabilities are provided reasonable accommodations. If reasonable accommodation is needed, please alert the recruiter if you are selected to move forward.

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.