Senior Engineer, Global Supplier Quality

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