Maintain detailed reports related to contract manufacturers quality performance
Provide technical guidance and advice to suppliers and decision-maker
Communicate between contract manufacturers and senior management to identify issues in contract manufactured quality and provide guidance and lead process enhancements and improvements projects
Function as part of a supplier assessment team performing on-site inspections of quality system audits at suppliers and evaluate partner suitability and to drive process standardization, waste elimination and continuous improvement.
Perform on-site and internal supplier development activities and continuous improvement initiatives with key partners
Facilitate problem solving and root cause analysis to eliminate recurrence of non-conformance
Help establish, monitor, and improve key performance indicators at contract manufacturers
Work to resolve contract manufacturing technical issues in a timely manner to ensure continuity of supply
Performs Document Control processes to ensure all Procedures are properly documented, updated as needed and in compliance with regulatory requirements.
Coordinate chemical and microbial testing of finished products
Prepare data for quarterly supplier reviews
Lead Supplier Corrective Action Requests (CAPA)
Work with contract manufacturers and internal teams to resolve quality issues
Participate in pilot and/or first product runs performed by contract manufacturers

BS/BA in related discipline, or advanced degree, preferred or equivalent combination of education and experience.
Typically, 3-5 years of experience in a Quality role
ASQ Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA), Six Sigma Green or Black belt is a plus
Knowledge of applicable Quality System requirements (GMP and ISO 9001) is strongly desired
Ability to manage multiple projects/activities; results driven
Excellent communication and interpersonal skills.
Proficiency with MS Office Products (Word, Excel, PowerPoint, etc.)

Supplier Quality Engineer

Key skills