Senior Supplier Quality Engineer at Abbott Pediatrics

Irvine, California, United States -

Full Time

Start Date

Immediate

Expiry Date

16 Feb, 26

Salary

173300.0

Posted On

18 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Supplier Quality Engineering, FDA Regulations, GMP, ISO 13485, ISO 14971, SAP, Data Analysis, Project Management, Six Sigma, Lean Manufacturing, Statistical Analysis, Problem Solving, Coaching, Mentoring, Communication, Interpersonal Skills

Industry

Hospitals and Health Care

Description

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works out of our Irvine, CA location on our EP (Electrophysiology) Quality team. Supplier Development Quality Engineer responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection. Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet company and regulatory requirements. What You’ll Work On • Contributes to the development, maintenance and improvement of division supplier development quality program policies, procedures and forms. • May provide coaching and mentoring for technical team personnel. • Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements. • Reviews and approves all supplied product drawings and component quality plans. • Manages development of supplied product inspection procedures and first article requirements. • Provides engineering guidance to division Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies and inspection procedures. • Assesses supplier capabilities through direct visits, technical discussions, directed testing and quality system audits. • Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests and technical discussions. • Participates and provides engineering ownership for all supplied product Non-Conforming Material Reviews. • Contributes and participates in supplier performance reviews. • Evaluates and develops Supplied Data Agreement partnerships with suppliers. • Applies sound engineering analysis and judgment to reduce the need for inspection in accordance to program policies. • Works with Manufacturing engineering to assess and address purchased product issues. • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues • Design and conduct experiments for process optimization and/or improvement • Participate in or lead teams in supporting Supplier Development Quality program requirements (e.g., represent the Supplier Development Quality function as a Core Team Member) • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Required Qualifications Minimum 5 years of related experience in supply chain, planning, or operations. Medical device industry experience preferred. Demonstrated supervisory or leadership experience. Background in engineering and use of quality tools/methodologies. Strong knowledge of FDA regulations, GMP, ISO 13485, and ISO 14971. Experience with SAP and maintaining master data integrity. Solid communication and interpersonal skills. Proven project management and leadership capabilities. Advanced computer skills including data analysis and report writing. Experience with Six Sigma, Lean Manufacturing, or other improvement methodologies. Preferred Qualifications ASQ CQE or other relevant certifications preferred. ISO 13485 auditing experience preferred. Experience working in a cross-divisional or enterprise-level business model. Ability to thrive in a matrixed and geographically diverse environment. Strong team collaboration and individual contributor skills. Ability to engage and influence others to accomplish goals. Effective communication across multiple organizational levels. Willingness to potentially travel 10%, including internationally. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews. The base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted.

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Responsibilities

The Senior Supplier Quality Engineer is responsible for supplier selection, evaluation, and performance management. This role also involves developing and maintaining supplier quality engineering methodologies and systems to meet regulatory requirements.