Join our cardiovascular EP client’s rapidly growing team and help as they embark on an exciting phase of their development! The company is eager to find a talented Quality Engineer to facilitate quality activities. This person will provide engineering support to new product development teams and/or sustaining manufacturing/operation teams. This role ensures products are developed per regulatory requirements, customer expectations, and industry standards.
Requirements of the Senior Quality Engineer:
- Bachelor’s degree in Engineering or scientific field with 3+ years of Quality Engineering, Manufacturing, or R&D experience
- Medical Device experience required
- Hands-on experience with Design Assurance, Design Controls, Design Verification & Validation, and Test Method Development
- Experience working in the medical device industry
- Strong working knowledge of risk management and hazard analysis (ISO 14971)
- Familiarity with IEC 62304 and IEC 62366 (highly preferred)
- Strong technical writing skills with ability to create protocols, reports, and procedures
Responsibilities of the Senior Quality Engineer:
- Provide Quality Engineering support across design controls, risk management (ISO 14971), and statistical techniques for medical device products
- Lead design assurance activities including feasibility testing, verification & validation, process validation, and design transfer
- Develop, review, and maintain QMS documentation including SOPs, work instructions, risk files, DHF, DMR, labeling, and change control
- Manage CAPA, nonconformance investigations, supplier qualification, component qualification, and environmental monitoring activities
- Support manufacturing operations through yield improvement, cost reduction initiatives, equipment qualification, and site transfers
- Support internal and external audits, regulatory inspections, and corrective action resolution
- Provide day-to-day quality support and training to cross-functional teams
- Track and report key quality metrics aligned with business and compliance objectives
Occupational Category: 17-2199.02 Validation Engineers
Application Instructions: Please apply using the form or send your resume to
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