The Sr. Supplier Quality Engineer who will serve as Abiomed’s Quality technical contact with all US-based suppliers, participate in all product/process improvement team’s supplier initiatives, supplier risk mitigation plans, second source critical suppliers and establish “Quality at the Source” programs with key partners.
Principle Duties and Responsibilities:
Attend all product/process improvement project meetings and serve as primary Quality liaison for all actions associated with new/existing supplier requirements including risk mitigation efforts
Oversee outside supplier activity as appropriate, ensuring all Quality issues are resolved in order to meet production demand
Lead the "Quality at the Source" program with the objective of increasing yields at the supplier and qualifying quality inspections at the supplier facility
Lead Auditor for all external audits and ensure audit schedule is developed and adhered to
Continuously monitor risk of the existing suppliers/components as well defining plans to mitigate risks including obsolete part management
Assist in qualifying new suppliers and defining necessary technical tests/documentation
Lead analysis of defective components found in Incoming Inspection and work with vendors to resolve (MRR Issue Resolution)
Lead/support the supplier evaluation process when selecting new vendors; Help maintain the ASL and supporting documentation required per SOPs
Participate in the investigation of failures and formulation and implementation of action plans for all internal corrective actions and audit findings; Address Incoming MRB in a timely manner
Use Lean and Six Sigma tools to analyze process trend data or communicate issues based upon data driven approach; Identify opportunities for vendor process and yield improvement projects
Resolve incoming inspection yield issues by driving tighter vendor process capabilities and ensuring appropriate internal drawing tolerances
Work to develop/maintain "Scorecard" for all suppliers on ASL
Skills/Requirements
Job Qualifications:
BS in Mechanical or Manufacturing Engineering required; MBA or MS desired
4 years of experience with detailed technical exchange with vendors; Medical device experience preferred
Knowledge of polymer, machining and/or metal cutting processes
Knowledge of Process Capability and data analysis using statistical tools
Strong Knowledge of lean, six sigma, kaizen and continuous improvement initiatives; Black Belt preferred
Ability to gain cooperation of others and lead team members
Demonstrated critical thinking in fast paced environment
Ability to exercise judgment in selecting, methods, techniques and evaluation criteria for obtaining results
Ability to communicate ideas and information clearly, effectively and frequently (oral and written)
Highly proficient in Microsoft Office Suite
Working knowledge of SAP desired
Willingness to travel, particularly to visit suppliers (20% required)
ABIOMED is an Equal Employment Opportunity/Affirmative Action employer. We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, veteran status, disability or national origin.
