JOB DETAILS

JOB DETAIL

Non-conformance related to Supplier (NC supplier):
- Manage all non-conformance of raw materials from quality issue.
- Communicate with supplier on quality issue to solve the problem and request root cause investigation including corrective and preventive action from supplier.
- Ensures the supplier executes failure investigation in an acceptable manner.
- Prevent the quality issue from supplier on raw materials.
Supplier quality management and control:
- Manage and maintain the list of approved suppliers (Approve Vender List) and their related documents in accordance with the group procedure.
- Manage supplier selection and qualification based on requirements of supplier quality procedure.
- Manage new/modify and disengagement suppliers activities following criticality level of supplier.
- Responsible for the quality and compliance oversight of supplier evaluations during selection and approval for the Selection and Qualification process.
- Manage and maintain Supplier Quality Agreements.
- Manage and maintain Supplier Quality Certifications.
- Evaluate and monitors supplier performance, and takes action with suppliers based on poor or unacceptable performance. Reporting supplier performance to management level and related stakeholders.
- Manages/supports supplier change control processes as applicable.
- Leads event-based Supplier product/process risk assessments.
- Manage and maintain Material Supply List.
- Manage supplier audit in the implementation requirements following supplier audit procedure.
- Establish annual supplier audit Schedule.
- Perform onsite audit supplier and documentation audit based on criticality level of suppliers.
- Participates in the development of the supplier audit and coordinate the audits at the group level (Thailand, France, India).
- Participates in the development of the supplier audit and coordinate the audits at the group level (Thailand, France, India).
- Control external auditor qualification.
- Control and maintain supplier quality management procedure.
- Supports the harmonization of supplier management across Peters Surgical Group.
- Manage data customization for all supplier quality management documents.
Supplier quality management for R&D:
- Manage and maintain all information required for R&D department such as Technical information, Hazard substance declaration and all related information.
- Manage and support information on KRM (Key raw material) specification as required by coordinate with supplier and Quality, Industrialization, R&D Peters Surgical.
- Communicate with supplier on all request information.
Supplier quality management for Validation:
- Communicate with supplier on all request information required for Validation such as manufacturing environment, manufacturing and process validation.
- Coordinate with supplier to requestion information on specific process from supplier manufacturing for Validation.
- Customer complaint management: Supplier Quality Supervisor authorized to manage customer complaints based on role and responsibility in Job Description of Quality Engineer.

REQUIRED WORK EXPERIENCE

- Bachelor’s degree or higher in Science or Engineering, management skill is advantage.
- Minimum 3-8 years in QA/QC especially in Medical Devices manufacturing with Quality system audit.
- Experience in supplier quality management.
- Specific skill/knowledge: ISO 9001 or ISO 13485 and regulatory requirements for medical devices or other quality systems.
- Higher education in quality desired. Knowledge of ISO quality standards.
- Proficiency in office: Excel, Word.
- Fluent in English