The Supplier Quality Engineer plays a pivotal role in ensuring quality and compliance of materials used across the organization.
Key Responsibilities
1. Supplier Onboarding and Monitoring:
* Manage supplier qualification and monitoring processes in compliance with company standards.
* Maintain supplier documentation, including qualifications, certifications, and performance records.
* Evaluate supplier criticality in collaboration with engineering teams for sourced components.
2. Quality Assurance and Improvement:
* Generate and analyze quality metrics for supplier performance reviews and management reporting.
* Collaborate with suppliers to resolve quality issues using NC and SCAR processes.
* Drive quality improvement initiatives with suppliers to enhance material performance.
3. Auditing and Compliance:
* Conduct supplier audits to ensure compliance with ISO 13485, EU GMP, and other regulatory standards.
* Prepare and maintain supplier quality agreements and oversee technical evaluations of new suppliers and materials.
* Monitor adherence to Change Request processes and Good Manufacturing Practices (GMP).
4. Material Management:
* Oversee incoming inspection processes and manage inventory of materials under review.
* Lead the Material Review Board (MRB) to ensure timely resolution of non-conforming products.
* Ensure the approved supplier list remains current and accurate.
5. Cross-Functional Collaboration:
* Work with internal teams (Manufacturing, Engineering, and Quality) to address material quality issues.
* Foster effective communication and positive relationships with suppliers and internal stakeholders.
* Lead or support supplier and internal projects aimed at improving quality and operational efficiency.
To be successful in this role, you will need a Bachelor's degree in Engineering, Quality, or Science, along with at least 2 years' experience in a regulated Medical Device or Pharmaceutical environment.
You should have strong knowledge of ISO 13485; familiarity with 21 CFR Part 820, EU GMP, or Eudralex Volume 4 is an advantage. Proficiency in Statistical Process Control (SPC) and statistical analysis techniques is essential.
Additional Requirements
* Ability to travel up to 5% of the time.
* Physical capability to manage light lifting (up to 10lbs/4kg) and perform tasks requiring minimal exertion.
* Mental acuity to interpret technical data, make informed decisions, and communicate effectively with cross-functional teams.