Job Description
Qualifications
Education Level Major/Field of Study
Bachelor's degree in engineering or Technical Field
Minimum 5 years Related experience
Engineering experience and demonstrated use of Quality tools/methodologies
Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14+71
Solid communication and interpersonal skills
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
Advanced computer
skills, including statistical/data analysis and report writing skills
Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
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 travel approximately 10-40%, including internationally
ISO Audit Certifications for performing Supplier Auditing (ISO 13485 and +001)
Benefits
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
Responsibilities
Supplier Development Quality Engineer responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection
Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet company and regulatory requirements
Contributes 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 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 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 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
Job description
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, material qualification, supplier performance and receiving inspection. Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet company and regulatory requirements.
MAIN RESPONSIBILITIES
• Contributes 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 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 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 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.
QUALIFICATIONS
Education
Education Level Major/Field of Study
Bachelor's degree in engineering or Technical Field
Advanced degree preferred
Experience/Background
• Minimum 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 14+71.
• Solid communication and interpersonal skills.
• 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. Advanced computer
• skills, including statistical/data analysis and report writing skills.
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and 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, changing
• 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 travel approximately 10-40%, including internationally.
Preferred Skills:
ISO Audit Certifications for performing Supplier Auditing (ISO 13485 and +001)
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.
Education Level Major/Field of Study
Bachelor's degree in engineering or Technical Field
Minimum 5 years Related experience
Engineering experience and demonstrated use of Quality tools/methodologies
Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14+71
Solid communication and interpersonal skills
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
Advanced computer
skills, including statistical/data analysis and report writing skills
Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
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 travel approximately 10-40%, including internationally
ISO Audit Certifications for performing Supplier Auditing (ISO 13485 and +001)
Benefits
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
Responsibilities
Supplier Development Quality Engineer responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection
Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet company and regulatory requirements
Contributes 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 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 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 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
Job description
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, material qualification, supplier performance and receiving inspection. Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet company and regulatory requirements.
MAIN RESPONSIBILITIES
• Contributes 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 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 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 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.
QUALIFICATIONS
Education
Education Level Major/Field of Study
Bachelor's degree in engineering or Technical Field
Advanced degree preferred
Experience/Background
• Minimum 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 14+71.
• Solid communication and interpersonal skills.
• 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. Advanced computer
• skills, including statistical/data analysis and report writing skills.
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and 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, changing
• 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 travel approximately 10-40%, including internationally.
Preferred Skills:
ISO Audit Certifications for performing Supplier Auditing (ISO 13485 and +001)
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.
💡 Quick Summary
Seeking a career-building opportunity? The Senior Supplier Development Quality Engineer position is now open for candidates interested in the Labour/Helper Jobs sector. This role in Pleasanton offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Labour/Helper Jobs is a plus.
