Senior Supplier Quality Engineer

Date: Jul 17, 2021

Location: Wallingford, CT, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 3957


Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

Interfacing with Supply Chain, R&D, Design Assurance and Manufacturing Teams, this Wallingford, CT based Senior Supplier Quality Engineer is responsible for Supplier Quality Management for Teleflex’s Z-Medica portfolio of hemostatic medical devices. This position acts as a valuable resource for areas including qualification, issue resolution, change management, and performance monitoring of Suppliers within a highly regulated Medical Device manufacturing environment.

Principal Responsibilities

  • Create and maintain strong relationships and effective lines of communication with Suppliers.
  • Develop partnerships across multiple facilities with Supply Chain, R&D, Design Assurance, and Manufacturing groups.
  • Lead the investigation, resolution, and prevention of supplied component nonconformances.
  • Trend data, identify improvement projects, and implement improvements (increase capability, reduce scrap, improve/repair processes, etc.) at Teleflex and at Supplier to improve quality and supplier performance.
  • Initiate and follow-up Supplier Corrective Actions (SCARs) in partnership with impacted cross-functional groups to ensure complete and effective root cause analysis and corrective action implementation.
  • Perform periodic audits of Supplier quality systems to assure continued Supplier conformance to the quality system requirements.
  • Manage, review, and approve Supplier change requests and partner with Sustaining Engineering, Regulatory, and Supply Chain to develop and implement appropriate strategies to support qualification through the change approval process.
  • Recommend and drive continuous improvements in the Supplier Quality organization, to improve the related systems and processes at Teleflex.
  • Create and/or sustain Supplier Quality procedures.
  • Prepare and negotiate Quality Agreements with Suppliers.
  • Assess potential new Suppliers for technical, quality, and manufacturing capabilities.
  • Lead cross-functional projects with concise and clear plans that consistently hit project milestones, as well as develop strong contingency plans as part of the project planning process
  • Collaborate with Suppliers to develop comprehensive process-validation strategies.
  • Support/Execute Supplier and Contract Manufacturers Validation Efforts.
  • Lead/Execute Process Validations and Test Method Validations.
  • Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Initiate and lead change orders, deviations, and investigations to maintain compliance
  • Support Design Transfers Validation efforts.
  • Support Risk Management effort from Quality perspective.
  • Assist the business units with the acquisition of new companies and/or the integration of new suppliers into the Teleflex quality system.
  • Adhere to and ensure compliance to the Teleflex code of conduct, all company policies, rules, procedures, and housekeeping standards.
  • Other responsibilities assigned to support the Quality System as needed.

Education / Experience Requirements

  • BA/BS in Engineering or physical sciences
  • 5-10 years of experience working within an FDA regulated industry, Medical Device preferred.
  • Advanced knowledge of 21 CFR 820, ISO 13485, and relevant regulations (MDD, MDR etc.).
  • Minimum 3 years of auditing experience (3rd party certification preferred).
  • Certification preferred (ASQ CQE and/or CSQP).

Specialized Skills / Other Requirements

  • Ability to leverage, influence and/or engage others to accomplish projects
  • Self-starter with the ability to quickly learn about new processes, projects, and requirements
  • Strong verbal and written communication skills, including the ability to write technical reports / presentations and to negotiate Supplier Quality Agreements
  • Solid organizational and follow-up skills, as well as attention to detail
  • Advanced problem-solving skills and root cause analysis experience.
  • Critical thinker with analytical problem-solving skills, able to resolve quality-related issues in a timely and effective manner
  • Knowledge of quality-related tools including, but not limited to, SPC, DOE, TMV, and Quality Systems
  • Experience with various process-improvement methodologies, such as Six Sigma and Lean Manufacturing
  • Knowledge of advanced statistics and data analysis.
  • Working knowledge of US and international medical device regulations, standards, and guidance documents. Including:
  • 21 CFR 820 US FDA Quality System Regulations
  • ISO 13485:2016 Medical Devices – QMS – Requirements for Regulatory Purpose
  • MDD 93/42/EEC Medical Device Directive (European)
  • Regulation (EU) 2017/745 Medical Device Regulations
  • ISO 13485:2016 Lead Auditor Certified, or similar Lead Auditor certification (ASQ CQA, for example)
  • Experience with applications such as, Word, Excel, PowerPoint, SharePoint, Minitab, and statistical applications.

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, 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.

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Nearest Secondary Market: Hartford