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Sr. Supplier Quality Engineer

Abbott

New Brighton, MNJob$78–156K/yrTracked 3w agoSeen in employer's feed 1w ago

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At a glance

Compensation
$78–156K/yr
Location
New Brighton, MN
Work Authorization
Not specified

Job overview

Abbott is hiring a Sr. Supplier Quality Engineer. Abbott seeks a Sr. Supplier Quality Engineer for its Structural Heart team in New Brighton, MN, to lead supplier selection, evaluation, and quality program development, ensuring compliance with FDA, GMP, and ISO standards while mentoring technical staff and collaborating across functions.

Key focus areas include Contribute to development and improvement of supplier quality program policies and procedures, Provide coaching and mentoring for technical team personnel, and Guide and train purchasing, R&D, manufacturing and quality engineers on program requirements.

Important skills include FDA Regulations, GMP, ISO 13485, ISO 14971, SAP, and Master Data Integrity. Preferred (not required): Supplier Selection And Evaluation, Material Qualification, Supplier Performance, and Receiving Inspection.

Skills & qualifications

RequiredNice to have

Skills

FDA RegulationsGMPISO 13485ISO 14971SAPMaster Data IntegrityCommunicationInterpersonal SkillsProject ManagementLeadership CapabilitiesData AnalysisReport WritingSix SigmaLean ManufacturingSupplier Selection and EvaluationMaterial QualificationSupplier PerformanceReceiving InspectionSupplier Quality Engineering MethodologiesCoachingGuidance and TrainingReview and Approval of Supplied Product DrawingsComponent Quality PlansDevelopment of Supplied Product Inspection ProceduresFirst Article RequirementsStatisticsMeasurement TechniquesGage R&R StudiesSupplier Capabilities AssessmentQuality System AuditsSupplier Corrective Action RequestsTechnical DiscussionsNon-Conforming Material ReviewsSupplied Data Agreement PartnershipsEngineering AnalysisProblem-Solving MethodologiesProcess OptimizationProcess ImprovementTeam CollaborationIndividual ContributorEngage and Influence

Qualifications

5+ Years Supply Chain Experience5+ Years Planning Experience5+ Years Operations ExperienceSupervisory ExperienceLeadership ExperienceEngineering BackgroundMedical Device Industry ExperienceASQ CQE CertificationCross-Divisional or Enterprise-Level Business Model ExperienceAbility to Travel 10%

Benefits

Medical Insurance
Tuition Assistance

Full job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

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:

The Opportunity

This position works out of our New Brighton, MN location on our Structural Heart 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 (https://www.jobs.abbott/us/en)

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

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 $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email [email protected]

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