Abbott Laboratories
Senior Supplier Development Quality Engineer
Abbott Laboratories, Pleasanton, California, United States, 94566
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.MAIN PURPOSE OF ROLE
Supplier Development Quality Engineer responsible for activities related to supplier selection and evaluation, materialqualification, supplier performance and receiving inspection. Contributes to the development, establishment andmaintenance of supplier quality engineering methodologies, systems and practices which meet company and regulatoryrequirements.
MAIN RESPONSIBILITIESContributes to the development, maintenance and improvement of division 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 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 correctiveaction 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 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 qualityissuesDesign and conduct experiments for process optimization and/or improvementParticipate in or lead teams in supporting Supplier Development Quality program requirements (e.g., represent theSupplier 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 andcollaboration with all levels of employees, customers, contractors, and vendors.
QUALIFICATIONSEducationEducation Level Major/Field of StudyBachelor's degree in engineering or Technical FieldAdvanced degree preferred
Experience/BackgroundMinimum 5 years Related experience. Prior medical device experience preferred.Demonstrated supervisory experience preferred. Engineering experience and demonstrated use of Quality tools/methodologies.Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.Solid communication and interpersonal skills.Strong project management and leadershipskills, including the demonstrated ability to lead multi-departmental project teams andresolve quality-related issues in a timely and effective manner. Advanced computerskills, including statistical/data analysis and report writing skills.Experienceimplementing various product and process improvement methodologies (e.g., Six Sigmaand Lean Manufacturing). ASQ CQE or other certifications preferred.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, changingenvironment. Ability to leverage and/or engage others to accomplish projects. Strongverbal and written communications with ability to effectively communicate at multiplelevels in the organization. Ability to travel approximately 10-40%, includinginternationally.Preferred Skills:ISO Audit Certifications for performing Supplier Auditing (ISO 13485 and 9001)
The base pay for this position is $83,600.00 – $167,200.00. In specific locations, the pay range may vary from the range posted.
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Supplier Development Quality Engineer responsible for activities related to supplier selection and evaluation, materialqualification, supplier performance and receiving inspection. Contributes to the development, establishment andmaintenance of supplier quality engineering methodologies, systems and practices which meet company and regulatoryrequirements.
MAIN RESPONSIBILITIESContributes to the development, maintenance and improvement of division 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 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 correctiveaction 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 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 qualityissuesDesign and conduct experiments for process optimization and/or improvementParticipate in or lead teams in supporting Supplier Development Quality program requirements (e.g., represent theSupplier 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 andcollaboration with all levels of employees, customers, contractors, and vendors.
QUALIFICATIONSEducationEducation Level Major/Field of StudyBachelor's degree in engineering or Technical FieldAdvanced degree preferred
Experience/BackgroundMinimum 5 years Related experience. Prior medical device experience preferred.Demonstrated supervisory experience preferred. Engineering experience and demonstrated use of Quality tools/methodologies.Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.Solid communication and interpersonal skills.Strong project management and leadershipskills, including the demonstrated ability to lead multi-departmental project teams andresolve quality-related issues in a timely and effective manner. Advanced computerskills, including statistical/data analysis and report writing skills.Experienceimplementing various product and process improvement methodologies (e.g., Six Sigmaand Lean Manufacturing). ASQ CQE or other certifications preferred.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, changingenvironment. Ability to leverage and/or engage others to accomplish projects. Strongverbal and written communications with ability to effectively communicate at multiplelevels in the organization. Ability to travel approximately 10-40%, includinginternationally.Preferred Skills:ISO Audit Certifications for performing Supplier Auditing (ISO 13485 and 9001)
The base pay for this position is $83,600.00 – $167,200.00. In specific locations, the pay range may vary from the range posted.
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