Supplier Quality Assurance Specialist

2 weeks ago


Zelienople, Pennsylvania, United States MILLENNIUMSOFT Full time

Job Title: Supplier Quality Engineer

Job Summary:

The Supplier Quality Engineer is responsible for ensuring the quality of suppliers and vendors, as well as monitoring and improving supplier processes. This role requires strong communication and project management skills to effectively coordinate activities and deliver results.

Key Responsibilities:

  • Provides focused supplier quality engineering support and assumes responsibility for timely and effective coordination and/or execution of assigned project activities
  • Acts as an effective team member in supporting quality discipline, decisions, and practices
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving supplier quality issues
  • Trends, analyzes, and reports on quality data to improve products and processes

Requirements:

  • BS in Electronics, Electrical, Mechanical, Bio-Medical, etc. required
  • 2+ years' experience in Medical Device manufacturing or similarly regulated industry required
  • Proven ability to develop and/or approve supplier PFMEAs, Control Plans, Measurement System Analysis, Special Process Validation, FAI, Routine Lot Acceptance activities is required
  • Experience with MS Office Products (Word, Excel, Visio, Project, PowerPoint, Outlook, etc.) required

Preferred Qualifications:

  • ASQ Certified Supplier Quality Engineer, ASQ Certified Quality Auditor, or equivalent preferred
  • Familiarity with ISO14971 and associated Risk Management Processes preferred
  • Three to five years of experience in a medical device quality assurance environment preferred
  • One to two years of auditing experience preferred


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