Quality Engineer, Internal Audits

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Date:
Sep 29, 2026

Location:

Wayne, NJ, US

Company:
Datascope Corp.

Remote Work: 1-2 days at home (site based)

Salary Range: $ - $ +10%
STIP

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

The Staff Quality Engineer, Internal Audits, is responsible for providing advanced technical leadership in the planning, execution, reporting, and improvement of regulated Quality Assurance activities for internal and external audits within the Cardiac Assist business. The position independently leads all, including complex, risk-based audits; evaluates systemic compliance and remediation effectiveness; coaches other auditors; and influences cross-functional quality-system improvements. The role assesses compliance with applicable FDA QMSR and related requirements, ISO standards, EU MDR requirements, MDSAP, other worldwide health-authority regulations and guidance, site procedures, protocols, and industry standards.

This position works from the Wayne, NJ office four days a week.

Job Responsibilities and Essential Duties

• Independently plans, leads, conducts, documents, and follows up on complex, risk-based internal audits and re-audits across Cardiac Assist functions, sites, and quality-system processes in accordance with the approved audit procedure and schedule.
• Serves as lead auditor for high-complexity or cross-functional audits; defines audit scope, criteria, sampling strategy, agenda, resources, and reporting approach based on product, process, compliance, and business risk.
• Prepares and issues timely, clear, evidence-based audit reports, including well-supported observations and nonconformities, classification or significance assessment as defined by site procedures, and an overall assessment of quality-system compliance.
• Ensures audit observations and nonconformities are appropriately contained, investigated, documented, corrected, and closed on time; evaluates root-cause adequacy, corrective and preventive action plans, implementation evidence, and effectiveness checks.
• Performs audit-program trend analysis to identify recurring, systemic, or emerging compliance risks and translates findings into prioritized improvement recommendations for Quality Compliance and Remediation leadership.
• Provides technical guidance and coaching to internal auditors and cross-functional subject-matter experts; supports auditor qualification, calibration, and development activities.
• Partners with Manufacturing, Quality Assurance, R&D, Engineering, Regulatory Affairs, Supplier Quality, and management to drive sustainable remediation and strengthen inspection readiness.
• Supports external audits and inspections by preparing objective evidence, conducting readiness assessments or mock audits, coordinating responses, and verifying commitments within the assigned scope.
• Leads or supports quality plans, gap assessments, corrective and preventive actions, management review inputs, and compliance remediation projects, ensuring deliverables are risk-based, documented, effective, and completed on time.
• Provides audit and compliance expertise for supplier controls, nonconforming material, incoming inspection, component qualification, validation, change control, complaints, product investigations, and post-market processes as applicable to assigned audits.
• Identifies and leads…