Role Overview
This position is responsible for end-to-end supplier management, which includes oversight of supplier sourcing and selection process, as well as the qualification (audit), monitoring, development, re-evaluation and decommissioning.
Duties and Responsibilities
Audit/Supplier Management
- Develop the Annual Global Supplier Audit plan and perform periodic supplier re-evaluation based on supplier risk
- Manage and update Global Approved Vendor List (AVL)
- Provide oversight for supplier assessments, escalate issues and lead risk assessments and mitigations, as appropriate
- Develop and negotiate Quality Agreement with suppliers.
- Collaborate with molding supplier to ensure molding process are robustly validated and documented.
Audit
- Lead and audit suppliers of material and services onsite. (e.g., molding supplier, Packaging supplier, CROs, warehouse, contract testing laboratory, Software supplier)
- Issue audit report and follow up on audit results including any non-conformances and CAPA implementation
Supplier Issue Investigation/Resolution
- Identify, initiate, and drive Supplier Corrective Action Reports (SCAR) response to ensure effectiveness of corrective and/or preventive actions implemented
- Ensure that non-conforming product/s is/are properly investigated and dispositioned. Work with the suppliers to ensure no reccurrence of non-conformances.
Supplier Performance Monitoring
- Lead the monthly Global Supplier Quality Performance Review meeting and closely monitor supplier performance. Take appropriate action on supplier to improve quality performance
- Ensure supplier's quality systems are aligned with current regulatory requirements, HOYA Surgical Optics (HSO) requirements and applicable standards
- Prepare QA metrics and participate in Quarterly Business Review (QBR) and Annual Performance Vendor review with suppliers and vendor management team
Change management and projects
- Ensure timely evaluation of Supplier Change Notification and initiation of change control process where applicable
- Support Supplier Development initiatives and implement supplier quality related improvement program.
- Participate and represent supplier quality on key projects. (Molding Projects, packaging materials, Improvement projects etc)
- Develop and/or revise Global SOP, Work Instructions and other supplier related documentations
- Trend and monitor supplier's in process data and collaborate with supplier to ensure process is operating in nominal condition.
Requirements
Education
- Bachelor's degree or Diploma in Science or Engineering
Experience
- Minimum 5-7 years of experience in medical device, bio/pharmaceutical industry
- Experience in supplier quality management preferred
Skills
- Demonstrated working knowledge in ISO 9001 / ISO 13485, QSR Part 820, Medical Device Regulation (MDR)
- Knowledge of Supplier Quality Management principles
- Expert knowledge in molding process and tooling highly preferred
- Ability to interpret engineering drawing and GD&T.
- ISO 9001/ISO 13485 Lead Auditor certification preferred
- Demonstrated knowledge and experience of Statistical Process Control (SPC) and Risk Management tools such as FMEA, Process Mapping, Hazard Analysis, MSA
- Demonstrated knowledge and/or experience in supply chain management, supplier development, risk management and conducting training
- Basic knowledge of product inspection and test techniques
- Good interpersonal skills and ability to influence people without direct authority
- Proactive and flexible in adapting to changing environment
- Able to manage and prioritize work with tight timelines
- Able to effectively influence and negotiate with suppliers and successfully lead change initiatives
Travel Requirements
- Approximately 10-20% locally and regionally
