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Abbott Supplier Development Quality Engineer II in Plymouth, Minnesota

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 107,000 colleagues serve people in more than 160 countries

EPHF Electrophysiology & Heart Failure

Leading an active lifestyle is important to the many people we serve. In Abbott’s Heart Failure division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in electrophysiology and heart failure, allowing people to restore their health and get on with their lives.

We are seeking an experienced, high caliber Engineer II Supplier Quality Engineer. Supplier Quality Engineers are responsible for activities related to supplier selection, evaluation, re-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.

Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take actions and accomplish goals.

WHAT YOU’LL DO

• Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements

• Performs re-assessment of suppliers each year per a defined schedule

• 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

• 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, 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

EDUCATION AND EXPERIENCE YOU’LL BRING

• 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

YOUR PREFERRED QUALIFICATIONS AND EDUCATION:

• 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

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

  • 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 communities

*Learn more about our benefits that add real value to your life to help you live fully: * www.abbottbenefits.com at http://www.abbottbenefits.com/pages/candidate.aspx

Follow 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 at http://www.abbott.com/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

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 corpjat@abbott.com

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