Senior Quality Engineer

Recruiting Director at Surf Search – Biotechnology, Medical Device, Pharma, Healthcare

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.

• 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

• 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

Seniority level:
Mid‑Senior level

Employment type:

Full‑time

Industry: Medical Equipment Manufacturing

Occupational Category: 17‑2199.02 Validation Engineers