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Senior Quality Assurance Engineer for Suppliers

2 months ago

Chelmsford, Massachusetts, United States Teleflex Full time

Position Title: Senior Quality Assurance Engineer for Suppliers

Company Overview:

Teleflex is a worldwide leader in providing clinically effective medical technologies aimed at enhancing the health and quality of life for individuals. Our commitment to innovation is driven by a focus on identifying unmet clinical needs, benefiting both patients and healthcare professionals. Our extensive portfolio encompasses solutions across various fields including vascular access, interventional cardiology, surgical procedures, anesthesia, cardiac care, interventional urology, emergency medicine, and respiratory care.

Department Overview:

The Global Operations division is a multifaceted organization dedicated to ensuring product fulfillment for our customers from start to finish. We emphasize a customer-centric approach, focusing on enhancing quality, service, and value as perceived by our clients. Our team is committed to the journey of enterprise excellence within Global Operations.

Role Summary:

The Senior Quality Assurance Engineer for Suppliers will serve as the primary liaison to Global Procurement, Site Buyers, and Site Quality, executing supplier quality functions for the procurement of commodities, purchased finished goods, and critical services. Key responsibilities include:

  • Leading initiatives to enhance supplier quality.
  • Fostering the development of suppliers to establish reliable and productive partnerships.
  • Acting as the main point of contact for assigned business units and manufacturing sites to address supplier-related issues and new projects.
  • Providing expertise in Purchasing Controls.
  • Drafting, coordinating, and reviewing supplier quality agreements.
  • Conducting supplier audits.
  • Mentoring team members.
  • Building strong collaborative relationships with Global Procurement, Supply Chain, Quality Assurance/Regulatory Affairs, Design, and Manufacturing teams.

Key Responsibilities:

  • Collaborate with Global Procurement and Site Quality to deliver appropriate supplier quality support.
  • Conduct compliance and qualification assessments for new suppliers.
  • Work alongside Strategic Sourcing and Site Buyers to enhance supplier performance in terms of quality, cost, and responsiveness.
  • Implement supplier development strategies for suppliers with quality issues, including executing quality plans and conducting audits.
  • Drive quality improvements for suppliers involved in product development or manufacturing.
  • Resolve ineffective corrective action plans with suppliers.
  • Coordinate quality testing for components and products.
  • Manage supplier-initiated change requests.
  • Analyze quality data to identify trends and implement proactive measures for continuous improvement.
  • Lead supplier-related initiatives aligned with business objectives.
  • Support business units in integrating new suppliers into the Teleflex quality system.
  • Participate in project teams focused on problem-solving methodologies.
  • Provide additional departmental support as required.

Qualifications:

  • Bachelor's degree in a scientific or technical discipline is preferred.
  • 5-10 years of experience in an FDA-regulated environment, preferably in the medical device sector.
  • Strong problem-solving and root cause analysis skills.
  • In-depth knowledge of regulatory standards such as 21 CFR 820, ISO 13485, and ISO 9001, particularly regarding purchasing controls.
  • Familiarity with statistical analysis techniques.
  • Minimum of 3 years of auditing experience (third-party certification is preferred).
  • Engineering degree or third-party engineering certification (e.g., ASQ CQE) is preferred.

Additional Skills:

  • Experience in manufacturing environments.
  • Proficiency in Microsoft Office Suite and statistical applications.
  • Exceptional verbal and written communication skills in English.
  • Strong presentation and team facilitation abilities.
  • Experience with Minitab is a plus.

Teleflex is an equal opportunity employer. We welcome applications from all qualified individuals without regard to age, race, gender, disability, or veteran status.