Job Description

Responsibilities:

• Coordinate suppliers, verify supplier quality standards are in accordance with Bio-Rad’s requirements and maintain accurate quality records, certifications and database records.
• Performs regular and routine quality audits to established and qualified suppliers in addition to auditing potential new suppliers’ processes and capabilities to ensure they meet the relevant regulatory standards and needs of the organization.
• Monitors supplier quality performance by tracking product defects, delivery failures and other recorded incidents involving supplier’s failure to meet requirements.
• Partners with problem suppliers to identify technical problems, root cause of quality issues and recommend/ensure timely corrective action is taken to secure continuity of supply.
• Track and qualify or disqualify suppliers according to Bio-Rad standards.
• Compiles Supplier Quality Reports for Management.
• Works closely with materials sourcing group to establish and maintain a Supplier Quality Scorecard.
• Maintain successful relationships with procurement, engineering, manufacturing and regulatory departments; including aiding manufacturing in the evaluation and qualification of new supplier materials following a defined NPI process.
• Develop long-term supplier relationships including implementing cost reduction ideas and leading supplier performance improvement projects.
• Assist in the development and implementation of supplier management programs.

• Bachelor’s degree or equivalent in engineering (Mechanical, Electrical or Chemical).
• 7+ years’ in an engineering, quality assurance and/or manufacturing supplier quality environment including audits and long term corrective action implementation.
• Experience with Six Sigma and/or Lean Manufacturing.
• Advanced knowledge of quality tools; i.e. supplier assessments, First Article Inspections (FAI), Failure Modes Effects Analysis (FMEA), 8D Problem Solving, Root-Cause Analysis, Corrective Action, Mistake Proofing and Process Control.
• Ability to perform complex statistical reporting, including skill in composing logical, detailed, and analytical reports.
• Good command of Microsoft Excel and/or Google sheets.
• Ability to work autonomously or under minimal supervision.
• Ability to create and deliver presentations to technical and non-technical audiences.
• Advanced verbal/written communication, interpersonal, organizational, analytical, problem solving, and time management skills.
• ASQ CQE, ASQ CQA, or ISO 13485 Lead Auditor Certification preferred.