DePuy Synthes part of the Johnson & Johnson Family of Companies is recruiting for a Site Staff Source Quality Engineer located in Horseheads, NY.
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.
The Site Senior Quality Source Engineer serves as the on-site Johnson & Johnson Medical Devices (JJMD) quality engineering representative for the Strategic Collaborator (SC). In collaboration with the SC, he/she utilizes quality engineering principles and problem-solving skills to improve and maintain JJMD products and processes. He/she supports the SC quality engineering team on initiatives impacting JJMD products and processes, including validation, risk management, product quality issue resolution and escalation, and quality systems performance monitoring. The Senior Quality Source Engineer is responsible for ensuring that the SC has a clear understanding and ability to execute to the JJMD/SC Quality Agreement requirements, J&J Policies, and applicable regulations and standards.
The Senior Quality Source Engineer will serve as the site liaison's deputy review and approve key quality records as they related to JJMD products report to the Site Senior Quality Source Manager
* Site Validation Master Plan Validation protocols and reports per Change Control Processes. High-risk CAPAs (i.e., Field Action, External Observations) * Conduct new or revised inspection plans and associated sampling strategies * Where necessary, collaborate with PSC in failure investigation and corrective action planning for High-Risk CAPAs (i.e. Field Action, External Observations) involving JJMD products. * Coordinates JJMD review and approval of Non-routine rework in collaboration with other required JJMD functions such as Design Quality, Product Management, and Sustaining Engineering * Use-as-Is Nonconformance Disposition in collaboration with other required JJMD functions such as Regulatory Affairs and Medical Affairs * Support Technical Assessments in collaboration with SC site compliance, JJMD Supplier Quality Compliance, and JJMD Product Management. * Partners with SC Quality Engineering, JJMD Medical Affairs, and JJMD R&D/PM in the development of Process Failure Mode Effects Analyses (pFMEAs) and corresponding Control Plans. * Supports SC Quality and Manufacturing Engineering on the resolution of quality issues impacting JJMD products and coordinates additional subject matter expert support needed from JJMD. * Supports improvement plans to address below-target metrics and negative trends. * Partners with SC on Recall Prevention and External Audit Readiness initiatives.
* A minimum of a Bachelor's Degree, preferably in Engineering or related technical field is required. * A minimum of 4 years related experience is required. * Experience working in both an FDA and European regulatory environment is preferred. * Experience with a proven track record of implementing appropriate risk mitigation. * Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making. * Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred. * A thorough understanding of GMP/ISO regulations and validation regulations is preferred. * Advanced knowledge and proven leadership in the areas listed in the Major Responsibilities and Duties with the position. * Quality Engineering Certifications are a plus (e.g. ASQ CQE, PMI PMP, 6-Sigma, etc.).
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability.
United States-New York-Horseheads-
Depuy Orthopaedics. Inc. (6029)
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.