Quality Engineer - Onsite - Ametek, Inc.

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This is a professional position with responsibilities for elements of the quality program. The Quality Engineer is experienced in multiple areas of medical device quality management and can apply that experience and knowledge to proactively drive continuous improvement initiatives and work independently with minimal guidance from management. The quality engineer also 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:

1.      Qualification

2.      Audits / Schedule

3.      Scorecards and Performance Improvement via Key Metrics

4.      Supplier Corrective & Preventive Action (SCAR) Process

5.      Quality Business Reviews

6.      Supplier Quality Agreements

7.      Supplier Records Maintenance

8.      Supplier Quality Manual/Procedure Development and Maintenance

9.      Certification Process

10.  Recognition Program

Incoming Inspection Management

11.  Review Inspection Records 

12.  Inspection Records Maintenance 

13.  Ability to read and interpret assembly and component prints 

14.  Part inspection, including layout, in process, final, and receiving, using all types of mechanical inspection 

15.  Basic knowledge of operating measurement equipment 

16.  Training of Inspectors

Non-Conformance Reports (NCR) and Material Review Board (MRB)

17.  Quality Key Metrics Reporting Internal/External/Supplier

18.  Develop Work Instructions

19.  Coordinate review, support investigation, impact, and corrective and preventative actions

20.  Support and develop IQ, OQ, PQ protocols, documentation, validation

21.  Support Calibration Program

22.  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).

23.  Utilize knowledge and expertise to identify, solve, and document problems and risks within the Quality Program.

24.  Support training (i.e., Supplier Quality Management, GMPs, Internal Auditing, FDA inspections, Quality Reporting, etc.).

25.  Serve as a Subject Matter Expert (SME) for colleagues. 

26.  Conduct Internal Audits and support External Audits (i.e. FDA, UL, etc.) 

27.  Support QARA Management in conducting Management Reviews. 

28.  Support Customer Complaint Management, Internal Audit, Risk Assessment, Document Control, CAPA processes, and Field Corrective Action (FCA). 

29.  Support data collection, quality report preparation and metric creation/deployment and performance process capability studies

30.  Support Engineering design review for regulatory compliance, verification/ validation, and manufacturing activities to ensure a robust product compared to customer requirements.

31.  Support Engineering and Purchasing with historical supplier performance data for evaluation/selection of new products. 

32.  Good oral and written communication skills, ability to communicate effectively with all levels of staff and management, both internal and external 

33.  Capacity to work independently from general supervision (must be self-motivated once given direction/guidance) 

34.  Excellent organization skills with the ability to perform multiple tasks and obtain results working within strict time frames 

35.  Strong attention to detail 

Education & Previous Experience:

• Bachelor’s degree in science or technical field
• 2-5 years in a manufacturing environment, of which 2+ years were in the Medical Device Industry
• Experience working with a Supplier Quality Program and its elements.
• Experience working in a Class I and Class II Medical Device environment.
• 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).

Preferred

• 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.