Job Description / Information : Lead Quality Engineering activities for design, development, manufacturing and/or distribution of orthopedic implants and instruments to ensure a high level of process and product quality. Minimum Qualifications : Bachelors Degree in Engineering or related field of study or equivalent work experience. Prefer CQE certification and Six Sigma Green or Black Belt. 3+ years experience as a Quality Engineer (QE) in a regulated manufacturing environment. Prefer experience with validation responsibilities. Demonstrated applied knowledge of: FDA and international medical device regulations. Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, SPC, Root Cause Analysis, Mistake Proofing/Poka Yoke. Demonstrated ability to effectively work cross functionally with other departments including Operations, Product Development and Marketing. Demonstrated problem-solving and troubleshooting skills. Demonstrated interpersonal and communication skills. Demonstrated ability to exhibit a positive, energetic approach to teamwork. Demonstrated ability to advocate product excellence and quality. Demonstrate results orientation, ability to multi-task, and ability to learn quickly. Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines. Computer proficiency with Mini-tab or similar analysis program, Visio, MS-Project highly desirable. Group Global Quality and Ops Division SGS Quality Assurance Business Function Quality Assurance