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Sr. Quality Engineer

PRINCIPAL RESPONSIBILITIES: 1.) Manage Nonconformance process including: - Facilitate daily Material Review Board meetings - Coach and drive NC investigation, containment and corrections while tracking progress; performing follow-up; and ensuring timely and effective completion. - Identify & create trend analysis for Nonconformance quality indicators to initiate CAPA and improvement efforts.  2.) Key contributor in the CAPA process and system by: - Leading monthly CAPA QSRB meetings; - Supporting and coaching CAPA leaders through the CAPA process - Reviewing and/or participating in root cause analysis, corrective action identification and verification of effectiveness planning.  3.) Participate in product complaint investigations with failure mode assessment and root cause analysis.  4.) Support product and/or process qualification utilizing validation process. design and process FMEA's. - Participate in design and phase reviews - Incorporate Design of Experiments (DOE) and other statistical tools within the validation process.  5.) Lead Perpetual Audit readiness activities and conduct internal or process quality audits as needed.  6.) Participate or drive any assigned Quality Improvement project or initiative.  7.) Assist, as needed, Supplier Quality management process, including supplier evaluations, SCARs and evaluation of supplier change notification requests. Conduct supplier audits, as necessary.  8.) Support risk management policies and procedures.  9.) Interface with various internal and external resources such as Manufacturing Product Development, Marketing, and Regulatory Affairs to assist with Post Market Surveillance, Product Complaint or Regulatory submissions. Adhere to and ensure the compliance of Teleflex's Code of Ethics, all Company policies, rules, procedures and housekeeping standards. This position requires direct contact with an implantable device. ? Yes ? No   Division InformationThe Corporate division is the central operating unit of the company setting strategy and policy and providing business development, finance, human resources, information technology, investor relations and legal support to the businesses. Company headquarters are located just outside of Philadelphia in Wayne, PA.LocationChelmsfordRemote LocationJob TitleSr. Quality EngineerOpportunity POSITION SUMMARY: The Senior Quality Engineer's primary responsibilities are leading, managing and driving improvement in 4 main areas of the Quality Management System, in support of Corporate Quality Objectives: CAPA & Nonconformance (NC) Process, including Material Review Board; Product Complaint Process; Design Control & Validation Process; Quality Improvement efforts related to Global or Local initiatives, such as ProActive Quality. The Senior QE position will lead a group of Quality Engineers and work within that team to ensure Quality System requirements are met. Additionally, this position will also support the Operational, Engineering and Post Market Surveillance team activities to ensure that product quality and services are achieved, maintained, and improved. Requirements EDUCATION / EXPERIENCE REQUIREMENTS: Bachelor Degree ASQ Certified Quality Engineer or Certified Quality Auditor preferred. 7-10+ years of Quality and/or related Manufacturing/Engineering experience with the following skills: CAPA, Nonconformance and MRB lead or management role Planning, controlling and assuring product and process quality QSR/ISO/CFR regulation knowledge and experience Medical Device Complaint Handling Quality system management and deployment experience. Reliability and risk management Problem solving and quality improvement, including quantitative methods Design Control and validation   SPECIALIZED SKILLS & OTHER REQUIREMENTS: MDSAP experience TRAVEL REQUIRED: As needed < 10%Company Information Teleflex is a global provider of specialty medical devices used for a range of procedures in critical care and surgery. We serve hospitals and clinicians in more than 130 countries with well known, trusted brands in vascular access, general and regional anesthesia, urology, respiratory care, cardiac care, and surgery. We also provide products and services for device manufacturers. Our products are designed to cost effectively provide clinical benefits and enable healthcare providers to improve outcomes and enhance patient and provider safety. Sr. Quality Engineer #18-6825
Salary Range: NA
Minimum Qualification
8 - 10 years

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