The Quality Engineer II will be responsible for cross-functional quality assurance, quality management/compliance, quality control, and activities associated with all Teleflex products and processes with a focus on manufacturing activities. In support of Corporate Quality Objectives, the incumbent will contribute, manage, and drive improvement in 5 main areas of the Quality Management System including CAPA & Nonconformance (NC) Processes; Incoming Inspection Improvements; Perpetual Audit readiness; Product Complaints identified as manufacturing related; and Quality Improvement efforts related to Global or Local initiatives, such as Cost Improvement Projects. Additionally, the Quality Engineer II will support the Operations, Engineering, R&D, and Post Market Surveillance team activities to ensure that product quality and services are achieved and maintained.
Principal Responsibilities
• Nonconformance (NC) and CAPA processing – lead quality activities such as inspection methods, NC containment, correction, closure and CAPAs; and drive improvement through analysis of trend data.
• Support Incoming & In-Process Inspection teams.
• Support the value stream with investigations required for field corrective actions including risk evaluation.
• Participate in internal audit activities and support supplier corrective actions as needed. Participate in vendor audits if necessary. Support the Back Room during regulatory and notified body audits.
• Production & Process Controls – review, change and approve manufacturing procedures; test method validations; Quality Inspection plans and process run sheets.
• Documentation Control – perform change controls (ADC/ECR/ECOs) as needed.
• Training – Perform QA training certifications on new production operators as needed.
• Support Engineering with new product development with quality planning, risk evaluation, and validation.
• Perform any additional QA tasks, as assigned by QA Manager.
• Maintain compliance with Teleflex Global & local procedures and policies.
• This position requires direct contact with an implantable device. ☐ Yes ☒ No
Education / Experience Requirements
• Minimum 4-year degree in an engineering discipline – Mechanical, Biomedical, Plastics, Industrial, etc.
• Minimum 2-3 years experience of quality and/or related manufacturing/engineering role, prefferably in a manufacturing site.
• Quality system management and deployment experience preferred.
• Problem-solving and quality improvement, including quantitative methods.
• Validations (product and process IQ/OQ/PQ).
Specialized Skills / Other Requirements
• Knowledgeable of ISO 13485, ISO 14971, and FDA QSR requirements.
• Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint is required.
• Working knowledge and/or experience with SAP and AGILE is strongly preferred.
• Good listening, verbal, and written communication skills
• Excellent interpersonal skills with a demonstrated ability to work in a team environment.
• Ability to prioritize and adapt to shifting priorities.
• Ability to work independently with limited supervision.
TRAVEL REQUIRED: 0-10 %
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At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front. Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com. Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.Quality Engineer II (Manufacturing) • Chelmsford, MA, US
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