Waters Corporation is seeking a Supplier Quality Engineer I to resolve supplier quality issues, analyze and measure supplier performance, implement corrective actions, and ensure adherence to quality standards, thereby impacting production schedules and overall business needs.
Requirements
- Working knowledge of ISO quality management systems 13485 and 21 CFR Part 820.
- Working knowledge of electrical and/or mechanical drawings (Geometric Dimensioning and Tolerancing-GD&T), and/or electrical and fluidic schematics.
- FDA 21 CFR 820 / ISO13485 / ISO 9001 / cGMP knowledge base
- Knowledge of various sampling plans
- Knowledge of Inspection Methods
Responsibilities
- Perform investigations into supplier issues to identify root causes and implement appropriate corrective actions to prevent recurrence of non-conformances.
- Carry out effective Supplier Corrective Action and Preventive Action (CAPA) investigations.
- Assess the adequacy of part acceptance criteria and make necessary improvements.
- Verify that inspection criteria are appropriate and effective.
- Conduct supplier audits to evaluate the effectiveness of supplier process controls and their Quality Management Systems (QMS), including both qualification and ongoing maintenance audits.
- Assist in the qualification and disqualification of suppliers in coordination with the Global Sourcing team, and initiate improvement plans as necessary.
- Provide guidance and ensure compliance with ISO13485, ISO 9001, 21 CFR Part 820, and applicable good manufacturing practice regulations within the company.
Other
- Minimum 1-2 years of experience in Supplier Quality or related field.
- Experience within a regulated industry (21 CFR 820, 21 CFR 211, ISO13485:2003, ISO9001:2008, AS9100, or TS16949) is preferred.
- Superior facilitation and communication skills.
- Capable of working independently and making informed decisions.
- Project Management Skills.
