Supplier Quality Engineer
The Supplier Quality Engineer plays a critical role in ensuring the quality and compliance of materials used across the organization.
Key Responsibilities:
* Supplier Onboarding and Monitoring:
o Manage supplier qualification and monitoring processes in compliance with company standards.
o Maintain supplier documentation, including qualifications, certifications, and performance records.
o Evaluate supplier criticality in collaboration with engineering teams for sourced components.
* Quality Assurance and Improvement:
o Generate and analyze quality metrics for supplier performance reviews and management reporting.
o Collaborate with suppliers to resolve quality issues using NC and SCAR processes.
o Drive quality improvement initiatives with suppliers to enhance material performance.
* Auditing and Compliance:
o Conduct supplier audits to ensure compliance with ISO 13485, EU GMP, and other regulatory standards.
o Prepare and maintain supplier quality agreements and oversee technical evaluations of new suppliers and materials.
o Monitor adherence to Change Request processes and Good Manufacturing Practices (GMP).
* Material Management:
o Oversee incoming inspection processes and manage inventory of materials under review.
o Lead the Material Review Board (MRB) to ensure timely resolution of non-conforming products.
o Ensure the approved supplier list remains current and accurate.
* Cross-Functional Collaboration:
o Work with internal teams (Manufacturing, Engineering, and Quality) to address material quality issues.
o Foster effective communication and positive relationships with suppliers and internal stakeholders.
o Lead or support supplier and internal projects aimed at improving quality and operational efficiency.
Qualifications and Experience:
* Bachelor's degree in Engineering, Quality, or Science is required.
* Minimum 2 years' experience in a regulated Medical Device or Pharmaceutical environment.
* Strong knowledge of ISO 13485; familiarity with 21 CFR Part 820, EU GMP, or Eudralex Volume 4 is an advantage.
* Experience in injection molding processes and validations is preferred.
* Proficiency in Statistical Process Control (SPC) and statistical analysis techniques is essential.
* Excellent verbal and written communication skills.
* Auditing experience to ISO 13485 or similar regulatory standards is highly desirable.
* Knowledge of Lean or Six Sigma methodologies is a plus.
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.