Supplier Quality Engineer II - Cardiac Rhythm
Overview
Own supplier quality for Abbott's Cardiac Rhythm Management division in Minnetonka, MN. You will drive corrective actions and improve component quality from external suppliers, ensuring reliability in life-saving heart devices. Collaborate with design engineering on new component selection and FDA regulations. This role offers direct impact on product quality and career growth at a global healthcare leader.
What You'll Do9
- 1Assess potential new suppliers for technical, quality, and manufacturing capabilities, focusing on ISO 13485 compliance.
- 2Generate and maintain incoming inspection procedures, and train inspectors on AQL sampling and IPC standards.
- 3Develop or source inspection tools and equipment, including CMM and optical comparators.
- 4Generate test protocols, monitor testing, issue qualification test reports, and approve components for use in products.
- 5Analyze incoming material defects, communicate issues to suppliers, and drive corrective action using CAPA processes.
- 6Review new design specifications and provide input on component quality and manufacturability from a supplier perspective.
- 7Investigate field failures related to supplier materials and develop corrective action plans using FMEA.
- 8Lead a project team of moderate scope and mentor less experienced staff, fostering a culture of quality.
- 9Supervise inspectors and manage daily work routines to meet schedule and regulatory requirements.
Requirements10
- 1Bachelor's Degree in engineering, quality, or related field, or equivalent combination of education and experience.
- 22-5 years of related work experience in supplier quality, manufacturing, or quality engineering.
- 3Working technical knowledge of ISO 13485 and FDA quality system regulations.
- 4Experience developing and maintaining inspection procedures and using statistical process control (SPC).
- 5Proficiency in CAPA, FMEA, 8D, and root cause analysis tools.
- 6Familiarity with medical device components and materials, such as plastics, metals, and electronics.
- 7Experience with supplier auditing and qualification processes.
- 8Strong communication and interpersonal skills to interface with suppliers and internal teams.
- 9Ability to work in a quality system environment with attention to regulatory compliance.
- 10Travel availability 5% of the time for supplier visits and audits.
Salary Insight
$61 - $123k per year
Location
Required Skills
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