Quality Supplier Engineer
Company: Abbott Laboratories
Location: saint paul
Posted on: May 3, 2021
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 109,000 colleagues
serve people in more than 160 countries.
S tructural Heart Business Mission: why we exist
Our 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 care.
Our location in St. Paul, MN, currently has an opportunity for a
Supplier Quality Engineer II. This position will manage suppliers
for Structural Heart, ensuring purchased materials meet
WHAT YOULL DO
- Execute and support on-time completion of Design Control
- Support on-time execution of Quality Plans for internal
development, OEM-based, Clinical Product Development (CPDP), and
design change projects
- Accountable for Design Verification and Validation planning &
execution, including active cross-functional root-cause analysis
investigation & resolution activities
- Lead or support Risk Management activities from product Concept
- Support design test and inspection method development, and lead
method validation activities
- Ensure DHF content completion, integrity, and regulatory &
standards compliance; collaboratively communicating & resolving
- Support manufacturing process development & qualification for
new product commercialization and product changes
- Support internal & external audit responses
- Support product re-certifications
- Support the establishment of objective, measurable, discrete,
and verifiable customer and product requirements
- Support objective component specification definitions, supplied
component sampling plan development, and vendor qualifications
- Support execution of biocompatibility and sterilization
- Complete Document Change Request Reviews in a timely and
- Manage Supplier Corrective Action Requests (SCARs)
- Manage Supplier Change Notifications (SCNs/SCRs)
- Manage Nonconforming Material reports (NCMRs)
- Additional duties may be identified by functional management
based on the current project/business objectives.
- Support all Company initiatives as identified by management and
in support of Quality Management Systems (QMS), Environmental
Management Systems (EMS), and other regulatory requirements.
- 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.
EDUCATION AND EXPERIENCE YOULL BRING
- Bachelors Degree in Engineering or Technical Field or an
equivalent combination of education and work experience
- 2+ years Previous Quality engineering experience and
demonstrated use of Quality tools/methodologies
- Experience working in a broader enterprise/cross-division
business unit model preferred. Ability to work in a highly matrixed
and geographically diverse business environment.
- Ability to work within a team and as an individual contributor
in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish
- Strong verbal and written communications with ability to
effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as
attention to detail.
WHAT WE OFFER
At 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
- Production areas that are clean, well-lit and
- 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
Learn more about our benefits that add real value to your life
to help you live fully: your 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 , Quality Supplier Engineer, Other , saint paul, Minnesota
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