Job Summary:
Reporting to the Senior Supplier Quality Engineer, the Supplier Quality Engineer will play a pivotal role in ensuring the quality and compliance of materials used across the organization. This includes managing the Supplier Quality Management (SQM) program, conducting supplier audits, overseeing incoming inspections, resolving non-conformance issues, and maintaining supplier performance. The role supports the quality standards for combination medicinal and device products assembled and packaged on-site, ensuring alignment with regulatory and organizational requirements.
Key Responsibilities:
- 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.
- 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.
- 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).
- 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.
- 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.
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
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
