Job Overview
We are seeking a highly skilled and experienced Supplier Quality Engineer to join our organization. In this role, you will be responsible for ensuring compliance with various regulations and standards, leading supplier quality compliance projects, developing partner quality agreements, managing high visibility SCARs, and conducting key supplier audits.
Key Responsibilities
1. Lead Projects as a Project Manager to improve supplier quality processes, resulting in improved efficiency and address compliance gaps.
2. Compile key quality agreements for business expansion with partners, ensuring alignment with company requirements.
3. Own supplier quality processes, including supplier selection, evaluation, and re-evaluation, SCAR process, and supplier monitoring as a global business process owner.
4. Run supplier monitoring boards with cross-functional stakeholders, presenting the status of supplier quality health with metrics on audits, SCARs, supplier nonconformances, and ASL.
5. Work closely with regulatory affairs/quality systems teams to periodically analyze and review supplier quality processes to ensure compliance with latest applicable regulations and standards.
6. Lead internal CAPAs related to supplier quality.
7. Lead high-visibility SCARs and key supplier audits (evaluations and re-evaluations) as a lead auditor.
8. Guide procurement on ASL maintenance and supplier qualifications and inactivation's.
9. Support internal and external audits representing supplier quality in audit front rooms.
10. Be a technical custodian of supplier data monitoring and analysis, analyzing and preparing data for supplier monitoring boards and monitor tools and dashboards for accuracy.
11. Review and approve product SCARs, supplier change requests, and quality agreements.
12. Provide guidance to international sites on local/regional supplier quality execution and maintenance.
13. Offer guidance to R&D project teams on supplier selection and onboarding.
Qualifications
* BS degree in engineering, pharma, biomedical, or health sciences or equivalent.
* 4+ years of related experience in supplier quality and/or product quality or related field.
* Knowledge of 21 CFR part 820, ISO 13485:2016, IVDR, MDSAP regulations (experience in auditing suppliers to these standards).
* Certified ISO 13485:2016 lead auditor credentials preferred or completion of a third-party certification training for lead auditor.
* Ability to travel to suppliers/sites on an as-needed basis.
* Proficient with Windows, Word, Excel, Agile, and SAP.
* Ability to read and interpret detailed product specifications and communicate technical information effectively.
* Strong organizational, written, and verbal communication skills.
* Leadership and project management skills.