Senior Quality Engineer (Pittsburgh, PA)
Smith & Nephew
- Pittsburgh, PA
- Permanent
- Full-time
- 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.
- Bachelor of Science Degree in Mechanical, Manufacturing, Electrical, Biomedical or 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.
- 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!