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, BiomedicalEngineering, 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://tinyurl.com/2mstyu3f

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.