Project Coordinator - Katalyst Healthcares & Life Sciences
Santa Rosa, CA 95401
About the Job
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.
- Audit Training (ISO 13485 and FDA 21CFR820Training).
- PLM Tools: Agile Map, Windchill, SAP.
- Power BI.
- ASQ CSQP and/or CQE Certificate.
- CAPA Training.
- Must have- SQE, Project management, communication skills, MFG process understanding.
- PLM.
Source : Katalyst Healthcares & Life Sciences
