Supplier Quality Engineer
Job ID :
US - Maryland - Frederick
- Leads and manages the execution of objectives for the control of suppliers, contract manufacturers and service providers in alignment with corporate goals and objectives; including assuring the supply of on-time, acceptable product and services. Including leading and performing supplier audits and evaluations.
- Supports continuous improvement with procedures, policies and quality assurance methodologies including but not exclusive to: new material qualification, end of life materials/components, product development process, supplier requests for material changes and sustaining engineering
- Collaborates with Procurement, R&D and Operations to effectively define roles and responsibilities and supply priorities and actions
- Ensures the Supplier Quality function operates according to procedures and provides direction to other departments related to supplier quality. Is a champion of problem solving and root cause analysis activities with suppliers and customers to eliminate recurrence of non conformance and complaints.
- Collaborates with the Procurement team assigned to support supplied products and materials. Develops long‐term supplier relationships, generates and implements cost reduction ideas. Aligns with Purchasing to report supplier performance while monitoring ratings and uncooperative suppliers
- Review and approves supplier records including but not exclusive to: contracts, quality plans, change requests, SCARs/CAPAs, NCRs, verification and validation protocols and reports.
- Supports and leads Supplier Quality meetings and other critical decision-making meetings as required to define Suppliers roles, responsibilities and effectiveness.
- Participate in the Supply Chain Risk Management Program.
- B.S. Engineering/Operations Management, Biological Sciences or equivalent
- Experience in Supplier Quality
- Solid experience with IS0 13485 or IS0 90001 and/or 21 CFR Part 820
- Excellent oral and written communication skills
- Fluent in English required.
- Lead auditor training and certification preferred
- Lean Six Sigma Green or Black Belt certified highly preferred
- International travel/foreign business exposure a Plus