Staff Quality Engineer, Internal Audits

Financeroles; North Carolina; On-site; USD 123,000 - 137,000; Full time

Benefits offered by this job

Health, Dental, and Vision insurance

401k plan with company match

Paid Time Off

Wellness initiative & Health Resources

Life Insurance

Short and Long Term Disability

Flexible Spending Accounts

Commuter Benefits

Parental and Caregiver Leave

Tuition Reimbursement

Job summary

Getinge in Wayne, NJ seeks a Staff Quality Engineer, Internal Audits, to lead advanced audits under FDA QMSR, ISO, EU MDR, and MDSAP, coordinating with Manufacturing, QA, R&D, and Regulatory Affairs.

The role requires coaching auditors, driving quality-system improvements, and readiness for external inspections. The ideal candidate has 8+ years in medical-device auditing and certifications such as Lead Auditor or CQE.

Qualifications

• Bachelor’s degree in Engineering, Science, Quality, or equivalent.
• Master’s degree preferred; relevant certifications valued.
• ISO13485, EU MDR, MDSAP knowledge and lead auditor experience.

Responsibilities

• Plan, lead, conduct, document, and follow up on complex internal audits.
• Serve as lead auditor for high-complexity or cross-functional audits.
• Prepare clear audit reports with observations and nonconformities.
• Ensure containment, investigation, corrective actions, and timely closure.

Skills

Auditing

Regulatory compliance

Quality-assurance

Leadership

Cross-functional collaboration

Risk-based thinking

Documentation & reporting

Communication

Education

Bachelor's degree in Engineering/Science/Quality

Master's degree preferred

Lead Auditor Certifications (ISO13485, MDSAP)

Certified Quality Auditor or CQE preferred

Tools

Microsoft Office

Audit management software

Electronic quality management systems

Job description

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 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%

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

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

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.