Senior Quality Engineer (Pittsburgh, PA)

Senior Quality Engineer, Smith & Nephew, Inc., Pittsburgh, PA: Lead the development, implementation, and enhancement of production monitoring methods and systems for inspecting and testing all new products. Interaction with the project team is essential to ensure quality in design for medical devices and application software, maintaining compliance with domestic and international regulations, standards, and applicable guidance documents. Responsible for the evaluation of products, manufacturing processes, assembly processes, and support for quality control activities are facilitated through training, the preparation of inspection procedures, and the provision of technical support. Telecommuting permitted up to 40% within the Pittsburgh, PA area. Monday – Friday, 40 hours per week. MINIMUM REQUIREMENTS: Bachelor degree in Mechanical Engineering, Manufacturing Engineering, Electrical Engineering, Biomedical Engineering, Industrial Engineering or a related field plus 4 years of progressive post-baccalaureate work experience in the job offered or related role. Of the required experience, must have 3 years of experience in all of the following: Process Validation (IQ, OQ, and PQ); Statistical Analysis such as capability study, sampling size calculation, design of experiment, or ANOVA; and Software Validation. Of the required experience, must have 2 years of experience in all of the following: Medical Device Industry; ISO 13485 Quality System Regulation; 21 CFR Part 820 Quality System Regulation; Test Method Validation (TMV); Gauge R&R Study; Root Cause Analysis (RCA); Non-Conformance Material Record (NCMR) Management; Corrective Action and Preventative Action (CAPA) process; Failure Mode and Effect Analysis (FMEA); and, Software bug tracking tools such as Jira or Bugzilla. Must be willing to travel up to 10% of the time (90% Domestic and 10% International) to visit other Smith & Nephew sites, vendors and attend conferences. This position is eligible for our employee referral program. A copy of the company’s ERP is available for reference here: https://tinyurl.com/4aebs4dh To refer someone for this job, please please follow the candidate referral tutorial, in order to submit your referral through Workday: https://smithnephew.service-now.com/$viewer.do?sysparm_stack=no&sysparm_sys_id=592fa5dfc3302e1051e3db4c050131b4 #LI-DNI 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. Stay connected and receive alerts for jobs like this by joining our talent community. We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day. Check our Glassdoor page for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S N. Explore our new website and learn more about our mission, our team, and the opportunities we offer. Smith Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith Nephew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited. 165 years of pioneering innovation requires a relentless focus on what’s next. We’re focused on you. You’re what’s next...Ready to take your career to the next level? Join our talent community for access to new job opportunities. Sign up now!