Principal Engineer, Supplier Quality
Lead Supplier Quality Engineering projects to improve supplier performance, support product launch, supplier qualification, supplier change notifications, process validations and product transfer. Organize and report key supplier performance metrics to the Quality organization and other departments. Perform supplier audits to evaluate quality systems, process, services, and supplier capabilities. Assist with Material Review Board (MRB) process to resolve issues with supplier related components and services. Drive supplier root cause analysis and corrective action process to prevent recurrence of quality issues. Job duties:
- Perform supplier risk assessment and participate in supplier selection to evaluate quality systems, processes, and services of suppliers.
- Oversee supplier monitoring, Supplier Corrective Action Request (SCARs), supplier related Non-Conformance Reports (NCRs), and purchased part assessment, and evaluate impact of supplier change requests.
- Assist with management of approved suppliers via the Approved Supplier List (ASL).
- Participate in the MRB process to drive supplier quality improvement as required.
- Execute (SCAR); review supplier quality performance and escalate based on risk, where needed.
- Work with R&D, Operations, and Procurement to ensure compliance for materials/components and services.
- Support regulatory compliance gaps at suppliers (e.g., supplier quality system and process development activities).
- Support supplier improvement programs, where needed.
- Travel domestically and internationally.
- Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
- Perform additional duties as assigned.
- Bachelor’s degree in Engineering or a related science discipline.
- Minimum ten (10) to twelve (12) years of total supplier quality experience in a medical device or a pharmaceuticals manufacturing environment.
- Six Sigma Greenbelt certified.
- Excellent written and verbal communication skills.
- Working knowledge of appropriate global medical device regulations, requirements, and standards such as ISO 9001, ISO13485, ISO14971, QSR, and MDD.
- Expertise/experience in root cause analysis, corrective/preventive action methods, and problem solving with quality tools such as: DMAIC / CAPA/ FMEA, 5 WHYs, MSA, SPC, etc.
- Audit experience in quality assurance activities for medical device and drug products.
- Experience with process validations.
- Proficient with MS Word, Excel, Outlook, and Teams.
- PMP Certification
- Six Sigma Black Belt Certified
- ISO13485 Certified Lead Auditor
- Certified Quality Engineer
- Advanced understanding of verification & validation, statistical techniques, and risk management.