Supplier Quality Engineer

Varite Acton , MA 01720

Posted 2 months ago

Supplier Quality Engineer Req I D

HR-01164

Rate

Primary Skills

Description

ESSENTIAL DUTIES AND RESPONSIBILITIES: Other duties may be assigned

  • Conducts Component Qualifications of new or changed supplier parts

  • Performs FAI for new product and product changes

  • Supports suppliers with the validation of their manufacturing processes

  • Conducts supplier audits and manages audit corrections

  • Performs root cause analysis and implements effective corrective action for supplier nonconformances

  • Establishes relationships with suppliers and actively drives continuous improvement

  • Develops and implements test methods and procedures for inspecting, testing and evaluating product and processes at supplier locations

  • Develops gauging methodology for products

  • Performs capability studies and gage R&R

  • Analyzes improvement opportunities through MRB monitoring

  • Ensures products and processes comply with regulatory and QSM requirements

Skill/Experience/Education

Mandatory:

EDUCATION, EXPERIENCE, QUALIFICATIONS AND SKILLS: -

  • Bachelor's degree in Engineering or a technical field is preferred

  • 5 years' experience in a regulated industry that includes FDA and ISO requirements

  • ASQ certification a plus

  • Displays developed communication and interpersonal skills: leadership, team orientation, ability to communicate at all levels

  • Teamwork, communication, positive attitude required to support the manufacturing environment

  • Ability to read and analyze technical prints and drawings

  • Problem Solving ability to perform root cause analysis and implement effective corrective actions

  • Ability to effectively manage and complete multiple projects simultaneously

  • Ability to conduct Process Failure Mode and Effect Analysis (PFMEA)

  • Excellent computer skills including but not limited to Microsoft Office Suite

QUALITY AND REGULATORY REQUIREMENTS: -

  • Knowledge of quality system including the quality manual, quality policy and applicable procedures and work instructions

  • Establish, implement, and maintain the quality system in accordance to FDA Quality System Regulation, ISO 13485, European Union Medical Device Directives, and Canadian Medical Device Regulations

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Supplier Quality Engineer

Varite