Supplier Development Quality Engineer_Medical Device Software Engineer II

Abbott   •  

Westford, MA

Industry: Healthcare

  •  

5 - 7 years

Posted Yesterday

  by    MH Veeresh

Software Engineer II – Westford,MA

· 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 SJM and regulatory requirements. Core Team member of New Product Development team.

· Job Description

Job Description

· Contributes to the development, maintenance and improvement of SJM supplier development quality program policies, procedures and forms.

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

o Reviews and approves all supplied product drawings and component quality plans.

o Manages development of supplied product inspection procedures and first article requirements.

o Provides engineering guidance to SJM Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies and inspection procedures.

o Assesses supplier capabilities through direct visits, technical discussions, directed testing and quality system audits.

o Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests and technical discussions.

o Participates and provides engineering ownership for all supplied product Non-Conforming Material Reviews.

o Contributes and participates in supplier performance reviews.

o Evaluates and develops Supplied Data Agreement, Skip Lot, Dock-to-Stock, CoC, and CoA partnerships with suppliers.

o Applies sound engineering analysis and judgement to reduce the need for inspection in accordance to program policies.

o Works with Manufacturing engineering to assess and address purchased product issues.

o Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues

o Design and conduct experiments for process optimization and/or improvement

o 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)

o Mitigates SJM risk by working with the Suppliers to document Process Flow Charts, PFMEAs, and Control Plans.

o 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.

Salary

$80K - $160K