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For your reference, we have included the original job posting below.
Quality Engineer
Job Number:
42019417
Company Name:
Stryker Corporation
Job Location:
Mahwah, NJ US
Job Categories:
Manufacturing & Production Engineering & Architecture
Quality Engineer
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.
• Ensure high level of compliance to FDA QSR/cGMPs and ISO 13485 in all assigned areas. • Work closely with internal departments (Operations, Advanced Operations, R&D, Distribution) to resolve in-house and supplier quality problems using established problem-solving methodologies (Root Cause Analysis, Mistake-proofing, etc.). • QEs in Operations will also: • Lead the resolution of quality issues related to non-conformance reports, cell shutdowns, customer complaints, regulatory actions, etc. • Lead and/or support CAPA investigations and related corrective and preventive actions. • Lead continuous improvement activities such as Quality Circles, Process Capability. Support Lean environment and re-work/scrap reduction. • Participate in the development and improvement of manufacturing, distribution and/or other processes for existing and new products. • Participate on project teams with internal departments to support product and/or process design and development activities. • Develop, review and improve inspection plans, routers and product drawings. • Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ). • Interface with suppliers for new processes, quality issues and process improvements for assigned projects. • Support product transfers to other plants/facilities. • Lead or participate in implementation of Process Management activities (pFMEA and control plans) within assigned client groups. • Review/approve product and/or process change control documentation and specifications. • Participate in continuous (breakthrough) improvement activity and process re-engineering projects.
Qualifications/Work Experience
• 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.
Education and/or Special Training
Bachelor's Degree in Engineering or related field of study. Prefer CQE certification and Six Sigma Green or Black Belt.
