at Ametek Inc. in Mount Prospect, Illinois, United States
Job Description
This is a professional position with responsibilities for elements of the supplier quality program. The Supplier Quality Engineer (SQE) is experienced in multiple areas of medical device supplier quality management and is capable of applying that experience and knowledge to proactively drive continuous improvement initiatives and work independently with minimal guidance from management. Serves as a technical reference and subject matter expert for colleagues with less experience. This position will provide leadership for improvement projects and will have the ability to solve problems affecting the quality system.
Key Responsibilities:
- Responsible for planning, organizing and conducting duties related to elements of the supplier quality program including:
- Supplier Qualification
- Supplier Audits
- Supplier Corrective & Preventive Action (SCAR) Process
- Supplier Audit Schedule
- Supplier Scorecards and Performance Improvement via Key Metrics
- Supplier Quality Agreements
- Training
- Non-Conformances
- Incoming Inspection Management
- Material Review Board (MRB)
- Supplier Quality Business Reviews
- Supplier Records Maintenance
- Supplier Certification Process
- Supplier Quality Manual/Procedure Development and Maintenance
- Supplier Recognition Program
- Comply with the Quality Management System (QMS) and all applicable requirements for medical devices (i.e., 21 CFR 820 Quality System Regulation; ISO 13485:2016; ISO 14971:2019).
- Utilize knowledge and expertise to identify, solve and document problems and risks within the Supplier Quality Program.
- Provide leadership for supplier related improvement projects.
- Support training (i.e. Supplier Quality Management, GMP's, Internal Auditing, FDA Inspections, Quality Reporting, etc.).
- Serve as a Subject Matter Expert (SME) for colleagues.
- Conduct Internal Audits and support External Audits (i.e., FDA, UL, etc.)
- Support QARA Management in conducting Management Reviews.
- Support Customer Complaint Management, Internal Audit, Risk Assessment, Document Control and CAPA processes.
- Support data collection, quality report preparation and metric creation/deployment.
- Support Engineering and Purchasing with historic supplier Performance data for evaluation and selection on new product.
Education & Previous Experience:
- Bachelor's degree in science or technical field and 3+ years' experience in the Medical Device Industry.
- Strong experience working with a Supplier Quality Program and its elements.
- Solid experience working in a Class I and Class II Medical Device environment.
- Extensive knowledge of medical device regulations/standards including 21 CFR 820 (QSR) and ISO - 13485:2016.
- Knowledge of ISO 14971:2019 (Risk Management for Medical Devices).
- Experience in conducting supplier audits.
- Experience supporting external audits (i.e., FDA Audits, Customer Audits, Corporate Audits, UL, etc.).
- Certifications preferred - i.e., Internal Quality Auditor, Certified QE, Risk Management, Certified Six-Sigma Black Belt.
- Knowledge of Lean/Six Sigma process improvement approaches and techniques.
Compensation
Salary Minimum: Market
Salary Maximum: Market
Incentive: No
Disclaimer: Where a specific pay range is noted,...
Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity
