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JOB TITLE: Quality Engineer
LOCATION:
Mahwah, New Jersey
Company Name:
Stryker
Stryker is an exceptional company with exceptional people who deliver exceptional results. We have differentiated ourselves by advancing meaningful innovations, creating cost-effective solutions for and improving the lives of our global customers and patients. As a winner of the 2007 and 2008 Gallup Great Workplace Award, we have demonstrated that Stryker has one of the most productive and engaged workforces in the world.
Our exceptional results fuel ongoing opportunities for Stryker employees to build outstanding careers and to develop and grow both personally and professionally. Our work environment attracts many different kinds of talented and driven people who love to win and serve others. We always put quality first. We hold ourselves accountable to reach or exceed our goals and continually improve everything we do. These attributes are shared by the employees that make up Stryker. They are the things that bring us together and serve as the foundation of all we do. And they are the enablers of both our past and future success.
Stryker is one of the worlds leading medical technology companies with the most broadly based range of products in orthopaedics and a significant presence in other medical specialties. The Company''s products include implants used in joint replacement, trauma, craniomaxillofacial and spinal surgeries; biologics; surgical, neurologic, ear, nose & throat and interventional pain equipment; endoscopic, surgical navigation, communications and digital imaging systems; as well as patient handling and emergency medical equipment. For more information about Stryker, please visit the company web site at: http://www.stryker.com.
JOB DESCRIPTION:
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.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
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: o Lead the resolution of quality issues related to non-conformance reports, cell shutdowns, customer complaints, regulatory actions, etc. o Lead and/or support CAPA investigations and related corrective and preventive actions. o 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
Participate in continuous (breakthrough) improvement activity and process re-engineering projects
Qualifications:
3+ years experience as a Quality Engineer in a regulated manufacturing environment.
Experience with validation responsibilities is strongly preferred.
Demonstrated applied knowledge of: o FDA and international medical device regulations. o 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:
B. S. degree in Engineering or related field of study. CQE certification and Six Sigma Green or Black Belt preferred.
Stryker is an equal employment opportunity/affirmative action employer committed to hiring a diverse workforce. To read more about Stryker, please visit our website at www.stryker.jobs. Additional Information Reference Code:9464BR. Contact Information: Stryker www.stryker.com Salary: Commensurate - Commensurate Job Code: 9464BR
Date this job was posted: November 6, 2009
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