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Quality Engineer

  • Location: Hopkinton, MA, United States
  • Salary: 40.0-45.0$ per hour +
  • Job Type:Contract

Posted 23 days ago

  • Sector: Professional
  • Contact: Daniella Adinolfi
  • Contact Email:
  • Contact Phone: 6466520984
  • Start Date: 03/22/2021
  • Job Ref: 21-04888
Duration extensions are possible but not guaranteed this is a project based position

Schedule 40 hourweek Monday Friday standard day schedule

Title ndash Supplier Quality Engineer

We are seeking an Engineering professional who works well in a crossfunctional team environment The individual will support our efforts to improve the quality of supplied parts through inspection support supplier audits and operations support for purchased parts The incumbent will be able to work with minimal supervision and resolve supplierrelated issues in a creative high quality timely and costeffective manner Core values must include commitment to customer and operations excellence with demonstrated ethics and integrity

bull Work with Operations Manufacturing Engineering Purchasing and Suppliers to resolve quality issues for purchased parts
bull Perform and support first article inspection FAI of new parts review FAI reports from vendors and support incoming inspection
bull Review and approve inspection plans and testing working with Engineering to inspect appropriate parameters
bull Investigate nonconforming parts to determine root cause and support the production floor for supplierrelated issues
bull Follow up with suppliers for supplierrelated nonconformances evaluate risk and initiate Supplier Corrective Action PlansReports SCARs with suppliers for issues of higher risk
bull Work with Purchasing to identify nonconforming part trends and supplier issue trends support Purchasing with supplier quality issues
bull Support Purchasing and Manufacturing Engineering with replacement of obsolete or discontinued parts
bull Monitor suppliers39 processes and performance through onsite audits and data review
bull Track and trend supplier performance and produce metrics and reports for Management Review
bull Review and approve deviations and change orders for engineering changes
bull Ensure compliance with applicable regulatory and statutory requirements in an ISO 9001 and medical device ISO 13485 and 21 CFR820 environment
bull Communicate effectively with stakeholders through meeting minutes and status reports
bull Recommend process improvements and actively stay involved in the global development of processes and tools
bull Provide support in general quality program issues to support Quality Department effectiveness

bull Requires a BS in Engineering Mechanical or Manufacturing preferred with a minimum of 12 years related experience andor training or equivalent combination of education and experience

Knowledge Skills amp Abilities
bull Working knowledge of ISO 9001 or Medical Device Regulations and Standards eg ISO 13485 ISO 14971 21 CFR 820
bull Ability to read drawings and use manual inspection measuring equipment
bull ASQ American Society of Quality certification or auditing certification a plus
bull Geometric Dimensioning amp Tolerancing knowledge or certification a plus
bull Operational ExcellenceSix SigmaLEANProject Management training or certifications a plus
bull Energetic resultsdriven with excellent organization prioritization and time management skills
bull Excellent written and verbal communication skills
bull Ability to operate independently and as part of a team with excellent collaboration and leadership skills
bull Computer proficiency with background in Agile and SAP business information systems a plus