Senior Supplier Development Quality Engineer
Company: Abbott Laboratories
Location: Saint Paul
Posted on: May 14, 2022
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 113,000 colleagues
serve people in more than 160 countries.Structural Heart Business
Mission: why we existOur business purpose is to restore health and
improve quality of life through the design and provision of device
and management solutions for the treatment of structural heart
disease. We aim to lead the markets we serve by requiring the
solutions we offer customers provide an improved benefit/risk
profile as compared to existing standards of care; a performance
threshold that by definition, guides and ensures the productive
output of our engineering, business development, and clinical
research efforts result in outcomes that advance the standard of
careOur team in St Paul, MN has an opening for Supplier Development
Quality Engineer to be 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 will do:
- Contributes to the development, maintenance and improvement of
division supplier development quality program policies, procedures
- May provide coaching, and mentoring for technical team
- Provides guidance and training to Purchasing, R&D,
Manufacturing and Quality engineers in applying program
- 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
- Evaluates and develops Supplied Data Agreement partnerships
- 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
- Design and conduct experiments for process optimization and/or
- 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
- Bachelors Degree in Engineering or Technical Field or
equivalent combination of education and work experience
- Masters Degree preferred
- Min 5 years of Related experience Prior medical device
- Demonstrated supervisory experience preferred. Engineering
experience and demonstrated use of Quality
- Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971. Solid
communication and interpersonal skills.
- Strong project management and leadership skills, including the
demonstrated ability to lead multi-departmental project teams and
resolve quality-related issues in a timely and effective
- Advanced computer skills, including statistical/data analysis
and report writing skills.
- Experience implementing various product and process improvement
methodologies (e.g., Six Sigma and Lean Manufacturing).
- ASQ CQE or other certifications preferred.
- Experience working in a broader enterprise/cross-division
business unit model preferred.
- Strong verbal and written communications with ability to
effectively communicate at multiple levels in the
- Ability to travel approximately 10-40%, including
internationally.WHAT WE OFFERAt Abbott, you can have a good job
that can grow into a great career. We offer: - A fast-paced work
environment where your safety is our priority (Manufacturing roles
only) - Production areas that are clean, well-lit and
temperature-controlled (Manufacturing roles only) - Training and
career development, with onboarding programs for new employees and
tuition assistance - Financial security through competitive
compensation, incentives and retirement plans - Health care and
well-being programs including medical, dental, vision, wellness and
occupational health programs - Paid time off - 401(k) retirement
savings with a generous company match - The stability of a company
with a record of strong financial performance and history of being
actively involved in local communitiesLearn more about our benefits
that add real value to your life to help you live fully:
career aspirations to Abbott for diverse opportunities with a
company that provides the growth and strength to build your future.
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 and
Keywords: Abbott Laboratories, St. Paul , Senior Supplier Development Quality Engineer, Engineering , Saint Paul, Minnesota
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