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Compensation Not Specified
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Required Education None
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Required Experience Less than 1 year
Job Details
Requisition ID 2312BR Job Title Associate Quality Engineer Group Orthopaedics Division Orthobiologics Business Function Quality Assurance Country United States State/Province PA City Malvern Employment Category Full Time Percent Travel Required Up to 10% Shift 1st About Stryker Stryker is one of the world’s leading medical technology companies and together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. Stryker products and services are available in over 100 countries. Job Description / Information The Associate Quality Engineer is responsible for leading 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. The Associate Quality Engineer will also support the development and introduction of new Orthobiologics products and support changes to existing product packaging and labeling. Specific responsibilities of the Associate Quality Engineer include, but are not limited to, the following: * 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, and Distribution) to resolve in-house and supplier quality problems using established problem-solving methodologies (Root Cause Analysis, Mistake-proofing, etc.) * 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 * 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 * Operate within Stryker’s quality system to produce/revise procedures and protocols related to the validation of packaging and/or labeling, and product stability * Execute product, package and/or label verification/stability testing per created protocols * Manage lower level projects and team initiatives Minimum Qualifications A Bachelors of Science Degree in Engineering and 0-2 years of experience as a Quality Engineer in a regulated manufacturing environment is required for this position. CQE certification and Six Sigma Green or Black Belt are preferred. Ideal candidates will also possess the following skills/experiences: * Experience with process validation is preferred * Applied knowledge of FDA and international medical device regulations * Demonstrated applied knowledge of 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 Product Development, Operations and Marketing * Demonstrated ability to advocate for product excellence and quality * Demonstrated problem solving and troubleshooting skills * Demonstrated results orientation, multi-tasking skills and the ability to learn quickly and work well in a team environment * Demonstrated ability to exhibit a positive, energetic approach to teamwork* Demonstrated ability to respond to urgent needs of the team and deliver expected results within expected deadlines * Strong interpersonal and communication skills (verbal & written) * Proficiency with Minitab or similar analysis program, Visio and MS Project * Demonstrated PC proficiency, including MS Office and MS Outlook