Job OverviewThe 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 implementation of improvements to audit methods, templates, metrics, data analysis, work processes, and quality-system controls.
- Escalates significant or systemic compliance concerns promptly and communicates risk, options, and recommended actions clearly to management.
- Coordinates and conducts Internal Audit Status Review and Reporting Meetings with required team members to ensure Internal Audit findings are addressed in a timely manner.
Minimum Requirements- Bachelor's degree in Engineering, Science, Quality, or an equivalent technical discipline is required; a master's degree is preferred.
- A minimum of eight years of progressive experience in auditing, quality compliance, quality assurance or a related regulated-industry function is required; a relevant master's degree may substitute for up to two years of experience, subject to company policy.
- Substantial medical-device quality-system auditing experience, including experience leading internal audits and participating in regulatory, notified body, customer, or corporate audits, is required.
- Demonstrated working knowledge of applicable medical-device regulations and standards, including FDA quality-system requirements QMSR, 21 CFR Parts 801, 803, and 806, ISO 13485, ISO 14971, EU MDR/MDD, MDSAP, and other worldwide health-authority requirements applicable to the role.
- ISO 13485:2016 Lead Auditor Certification, MDSAP Lead Auditor Certification, EU MDR Certification
- Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or comparable certification is strongly preferred.
Required Knowledge, Skills, and Abilities- Demonstrated ability to independently assess complex quality-system processes, integrate evidence from multiple sources, distinguish isolated from systemic issues, and make sound, risk-based compliance judgments.
- Advanced audit planning, interviewing, sampling, objective-evidence evaluation, report writing, root-cause evaluation, CAPA assessment, and effectiveness-verification skills.
- Proficiency in data and trend analysis, problem solving, and use of audit or quality metrics to identify emerging risks and improvement opportunities.
- Strong project leadership, prioritization, and execution skills with the ability to lead cross-functional work without direct authority.
- Effective influencing, conflict-management, facilitation, and change-management skills; able to communicate difficult findings constructively and maintain auditor independence.
- Clear written and verbal communication with the ability to present complex compliance issues to technical teams and management.
- Proficiency with Microsoft Office or equivalent applications; familiarity with electronic quality management, audit management, and analytical software is preferred.
- Decision-Making and Scope
- Operates with limited day-to-day direction and is accountable for the quality, timeliness, consistency, and defensibility of assigned audits and related remediation follow-up.
- Makes independent decisions within approved procedures and escalates matters that may represent significant patient, product, regulatory, or business risk.
- Influences site and functional improvements and contributes to annual audit planning, auditor allocation, risk prioritization, and audit-program performance reviews.
- Internal and External Contacts/Relationships
- Interfaces with all levels of management and staff across Cardiac Assist and relevant corporate or shared-service functions.
- Interfaces with FDA, notified bodies, other health authorities, customers, corporate auditors, suppliers, and consultants, as applicable to assigned responsibilities.
Base salary for this position is a minimum of $123,000 and a maximum of $137,000 plus annual bonus of 10%
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Benefits at Getinge:At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
