Title : Project Coordinator

Locations : Santa Rosa, CA- Onsite locals 

Must have- SQE, Project management, communication skills, MFG process understanding,

Nice to have - PLM

Key Responsibilities:

• Establish regular connects with supplier to evaluate Material changes to Parts/Components and decide the implementation actions.
• Collaborate with cross-functional teams to establish parameters for supplier assessment
• Able to understand Enterprise level data and understand supplier responses to survey campaigns
• Work with R&D, Bio-comp and other stakeholders to understand the Business requirements
• Handle suppliers' change requests, including communication, project management via MAP Agile workflow, and regular reporting.
• Able to understand Enterprise level data and understand supplier responses to survey campaigns
• Work with R&D, Bio-comp and other stakeholders to understand the Business requirements
• Ensure suppliers deliver quality parts, materials, and services.
• Evaluate suppliers' internal functions to assess overall performance and provide feedback.
• Qualify materials through the Production Part Approval Process (PPAP), including process validation, test method validation, technical writing, and project management.
• Monitor parts from acquisition through the manufacturing cycle, promptly identifying and resolving supplier-related problems.
• Collaborate with cross-functional teams to establish quality and performance metrics for suppliers.
• Establish regular connects with supplier to evaluate Material changes to Parts/Components and decide the implementation actions.
• Develop and maintain strong relationships with suppliers to ensure effective communication and alignment on quality expectations.
• Ensure compliance with all applicable regulatory requirements and company quality standards.
• Represent the company in supplier quality-related meetings and discussions.
• Proactively identify potential risks and implement risk mitigation strategies.
• Act as a subject matter expert on supplier quality and provide guidance and support to other departments as needed.
• Manage Supplier Change Requests and changes relating to supplier improvement initiatives
• Support supplier quality teams, to establish the processes for: Delivering quality parts, materials, and services, preventing defects.
• Develop and maintain quality standards for suppliers in accordance with industry regulations and company policies.
• Excellent organization, Planning, Computer skills, technical writing, Communication skills. MS Office Suite and Outlook.

Must Have:

Refer above table

Nice to Have:

• Audit Training (ISO 13485 and FDA 21CFR820Training)
• PLM Tools: AgileMap, Windchill, SAP
• PowerBI
• ASQ CSQP and/or CQE Certificate

CAPA Training