Supplier Quality Engineer II at Abbott Laboratories
Plymouth, MN 55447
About the Job
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 114,000 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 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.
- Free medical coverage for employees* via the Health Investment Plan (HIP) PPO.
- An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our Plymouth, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
As the Supplier Quality Engineer II, you’ll be responsible for activities related to new product development, supplier selection, evaluation, material qualification, supplier performance and receiving inspection. This position contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet Abbott and regulatory requirements.
What You’ll Work On
- Core team supplier quality lead for EP new product development projects
- Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements
- Identifies supplier contacts and solicits required documents from suppliers
- Tracks supplier responses and conducts follow-up and escalation as necessary
- Conduct phone calls with supplier as needed to expedite responses or answer questions
- Reviews current Quality Agreements and determines need to revise
- Solicits revised Quality Agreements as determined
- Obtains and analyzes performance and quality indications information from internal sources for each supplier
- Prepares and submits required quality records and documents for closure and filing
- Reviews and approves all supplied product drawings and component quality plans
- Manages the development of supplied product inspection procedures and first article requirements
- Provides engineering guidance to Abbott 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
- Evaluates and develops Supplied Data Agreement, Skip Lot, Dock-to-Stock, CoC, and CoA partnerships with suppliers
- Applies sound engineering analysis and judgment to reduce the need for inspection in accordance with 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)
- Mitigates risk by working with the Suppliers to document Process Flow Charts, PFMEAs, and Control Plans
- 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
- Contributes to the development, maintenance, and improvement of Abbott supplier development quality program policies, procedures, and forms
- Performs other related duties and responsibilities, on occasion, as assigned
Required Qualifications
- BS degree in Engineering or Technical Field or equivalent experience
- 2-5 years Medical Device and/or Engineering experience
- Ability to work in a highly matrixed and geographically diverse business environment
- Ability to leverage and/or engage others to accomplish projects
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
- 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 projects
- Strong technical writing skills
- Experience with root cause identification and problem solving
- Multitasks, prioritizes and meets deadlines in timely manner
- Strong organizational and follow-up skills, as well as attention to detail
Preferred Qualifications
- Advanced degree preferred
- Engineering experience and demonstrated use of Quality tools/methodologies
- Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
- 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 manner
- Prior medical device experience
- ASQ CQE or other certifications
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
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 and @AbbottGlobal.
The base pay for this position is $57,300.00 – $114,700.00. In specific locations, the pay range may vary from the range posted.
