Supplier Quality Engineer

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Job Details & Benefits

 

Every member of our worldwide team is integral in improving treatment and helping providers deliver exceptional care to their patients. From newborns to centenarians, more than 60 million people benefit yearly from the advancements we make in patient monitoring and management, care coordination, and clinical decision support.

 

Driven by the belief that anyone who seeks care could be a member of our own family, our team is dedicated to solving the greatest challenges the healthcare system currently faces, including the need to enhance the patient experience, improve population health, reduce costs, support care team well-being, and advance health equity. As part of our mission, we take pride in creating services and technologies that are personalized and tailored to support the needs of healthcare providers anywhere in the world.

 

While we may not be at a patient’s bedside, their health is still in our hands.

 

The Supplier Quality Engineer is responsible for supporting and maintaining Spacelabs quality programs across the supply chain (suppliers, service providers, contractors, etc.). This role will support execution for supplier quality to ensure supply base meets regulatory and industry standards according to Spacelab requirements and expectations.

 

This is a high-impact role that will support activities related to supplier quality and compliance (including qualification, approval, risk analysis, issue resolution, verification and validation efforts, etc.) associated with Spacelabs products. The individual will ensure compliant and effective execution of all quality processes and zealously drive and contribute to the safety and efficacy of company products.

 

The Supplier Quality Engineer will establish relationships across the supply chain in order to support supplier needs to support resolution of product issues and assist in identification of process improvement opportunities and to ensure safe and effective products and services.

Responsibilities

  • Collects and analyzes supplier performance to drive improvement and corrective action in the quality of materials / components sourced from suppliers; identify trends, drive corrective improvements, and report findings to management with quantified objectives.
  • Evaluates supplier caused manufacturing yield issues, incoming quality issues, and field failures.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving the issues.
  • Works cross-functionally in identifying and resolving technical issues.
  • Executes audits of suppliers to assess compliance with regulatory and Spacelabs requirements, including audit scheduling, investigation and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
  • Assess suppliers for technical, quality and manufacturing capabilities through direct on-site visits and technical discussions. Assists in the evaluation of proposed changes at suppliers.
  • Reviews and approves supplier corrective action plans and verification of effectiveness documentation.
  • Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. Interacts with suppliers. Participates in determining goals and objectives for projects. May lead projects within the department.
  • Facilitate and partner with suppliers to develop strong business and quality relationships ensuring strong communication and collaboration.

Qualifications

  • Bachelor degree in Science or Engineering required.
  • 5 + years of experience in manufacturing quality, engineering quality, or supplier quality (a combination of experience is acceptable).
  • 5+ years of medical device industry experience.
  • Working knowledge of quality process management and tools e.g. APQP, PPAP, SPC, process validation and verification, Statistics Tools and Analysis in development and revision of Quality Sampling Plans based on potential product and patient risk.
  • Applied experience with ISO 13485 (Quality Management Systems), FDA medical device regulations, cGMP, and Risk Management (ISO 14971) to instil a culture dedicated to ensuring patient safety and sustained regulatory compliance.
  • Additional applied knowledge of international standards and regulations preferred.
  • Proficiency in data analysis, trending tools, and KPI/dashboard development; professional knowledge of statistical methods.
  • Strong technical written and verbal communication skills; ability to work effectively across all levels of a global organization and remain composed in urgent circumstances.
  • Proficiency in multi-tasking and working in a high-paced, matrixed environment with an awareness of continued impact on compliance and operational performance.
  • Ability to lead and influence cross-functional teams, including Procurement / Supply Chain, Regulatory Affairs, Service and Research & Development to drive reduction in patient safety risk and greater levels of regulatory compliance.
  • Available for domestic and international travel up to 30%.

 

Contact Information

If you’re interested in submitting an application, please use the contact information below for more about how to apply.

Employer: Spacelabs Healthcare
Location: Snoqualmie

Contact: Tina Cooley
Email: tcooley@osi-systems.com
Phone: 425-281-7443
Website: https://www.osi-systems.jobs/careers-home/jobs/36161?lang=en-us