Abbott Supplier Development Quality Engineer II in Plymouth, Minnesota
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
A Supplier Quality Engineer drives improvement in the quality of components and services sourced from external suppliers. Provides technical support in the selection and evaluation of suppliers, monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures.
Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet SJM and regulatory requirements.
Contributes to the development, maintenance and improvement of SJM 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 SJM 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 judgement 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.
Performs other related duties and responsibilities, on occasion, as assigned
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
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 preferred
ASQ CQE or other certifications preferred
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 firstname.lastname@example.org