Job OverviewThe Staff Quality Engineer - CAPA & Compliance provides advanced technical leadership for Quality Management System compliance, with integrated responsibility for the CAPA process, QMS procedures and documentation, management controls, audits, metrics, and remediation. The position independently leads complex cross-functional CAPAs and compliance assessments, challenges the adequacy of investigations and controls, drives QMS harmonization and sustainable improvement, and coaches CAPA owners, investigators, and process owners.
This position works at the Wayne, NJ headquarters 4 days a week.
Job Responsibilities and Essential DutiesCAPA Management
- Independently leads and provides advanced technical oversight for complex, cross-functional, high-risk, recurring, or compliance-driven CAPAs from initiation through effectiveness verification and closure.
- Facilitates rigorous problem definition, containment, investigation, root-cause analysis, correction, corrective action, preventive action where applicable, implementation, and effectiveness-check planning using appropriate quality and statistical methods.
- Independently challenges investigation logic, objective evidence, risk assessment, root-cause conclusions, action plans, implementation evidence, and effectiveness criteria to ensure the CAPA is complete, scientifically sound, proportionate to risk, and audit ready.
- Assesses CAPA scope for systemic impact, affected products and processes, historical signals, related quality records, and potential need for escalation, expansion, field action, or regulatory evaluation by the appropriate functions.
- Leads CAPA Review Board meetings or designated governance reviews and communicates status, aging, extensions, recurrence, risk, barriers, decision needs, and recommended actions to management.
- Monitors CAPA performance and performs trend analysis across timeliness, recurrence, overdue actions, effectiveness, investigation quality, and closure quality; recommends targeted improvements.
- Coaches CAPA owners and investigators in the CAPA process and the electronic CAPA system, including phase transitions, traceability, approvals, objective evidence, and defensible record presentation.
Quality Compliance and QMS
- Independently assesses and improves Quality Management System processes and documentation for compliance with applicable regulations, standards, corporate requirements, and business procedures.
- Reviews the Quality Manual, procedures, work instructions, records, outsourced-process controls, document hierarchy, retention practices, and process interfaces to identify gaps, redundancies, inconsistencies, and simplification opportunities.
- Leads the creation, revision, combination, alignment, or obsolescence of QMS documentation to improve compliance, clarity, efficiency, and consistency across the Cardiac Assist business.
- Compares similar processes and procedures across applicable Cardiac Assist product and business areas and leads practical harmonization while preserving justified product-, site-, or process-specific controls.
- Collaborates with Corporate Quality and business stakeholders to translate enterprise QMS expectations into implementable local requirements and plans.
- Conducts focused compliance assessments, gap analyses, internal audits, and inspection-readiness reviews and supports external audits and regulatory responses.
- Develops and monitors quality metrics and management-review inputs for QMS performance, CAPA health, documentation effectiveness, remediation progress, and emerging compliance risk.
Integrated CAPA and Compliance Leadership
- Connects CAPA outputs to QMS improvement by ensuring systemic corrective actions are translated into controlled procedures, training, governance, records, systems, and sustainable process controls.
- Evaluates whether compliance gaps require correction, CAPA, broader remediation, document change, training, audit, or management escalation and ensures the selected pathway is justified and traceable.
- Leads cross-functional remediation plans arising from CAPAs, audits, inspections, gap assessments, or QMS harmonization activities and verifies implementation and effectiveness.
- Serves as an advanced subject-matter expert during internal audits, notified body audits, health-authority inspections, and corporate assessments for assigned CAPA and compliance topics.
- Coaches quality professionals, CAPA owners, investigators, and document owners and supports calibration, training, and consistent application of CAPA and compliance expectations.
Minimum Requirements- Bachelor's degree in Engineering, Science, Quality, or a related technical discipline is required; a master's degree is preferred.
- A minimum of eight years of progressive experience in quality assurance, quality engineering, CAPA, compliance, or related regulated-industry functions is required, including substantial hands-on experience managing complex CAPAs and creating or sustaining a medical-device QMS; a relevant master's degree may substitute for up to two years of experience, subject to company policy.
- Demonstrated experience with complex investigations, root-cause analysis, CAPA effectiveness, QMS procedures, document controls, gap assessments, audits, and cross-functional remediation is required.
- Advanced working knowledge of applicable medical-device quality-system requirements and standards, including FDA quality-system requirements, ISO 13485, ISO 14971, MDSAP, EU requirements, and other worldwide health-authority requirements applicable to the role.
- ASQ Certified Quality Engineer, Certified Quality Auditor, Six Sigma certification, ISO 13485 lead-auditor qualification, or comparable quality credential is strongly preferred.
Required Knowledge, Skills, and Abilities- Advanced investigation, root-cause analysis, problem-solving, risk assessment, action planning, effectiveness verification, QMS process assessment, and controlled-document development skills.
- Ability to integrate CAPA, complaints, nonconforming product, audit, supplier, validation, change-control, and post-market information to identify systemic contributors and emerging compliance risk.
- Ability to independently assess CAPA and QMS adequacy and constructively challenge unsupported conclusions, weak evidence, ineffective controls, or unclear procedural requirements.
- Strong project leadership, facilitation, prioritization, conflict-management, influencing, and change-management skills with the ability to lead without direct authority.
- Excellent oral presentation, technical writing, procedure-writing, and executive-summary skills.
- Proficiency with electronic quality management or CAPA systems such as TrackWise, Microsoft Office or equivalent tools, and analytical software such as Minitab or equivalent.
Decision-Making and Scope- Operates with limited day-to-day direction and is accountable for the quality, timeliness, consistency, compliance, and audit readiness of assigned CAPAs, QMS documents, assessments, and remediation deliverables.
- Makes independent decisions within approved procedures and escalates matters that may represent significant patient, product, regulatory, compliance, or business risk.
- Influences functional and site-level CAPA and compliance performance and contributes to program priorities, metrics, training strategy, document harmonization, and process improvement.
Internal and External Contacts/Relationships- Interacts with all levels across Cardiac Assist and relevant corporate or shared-service functions, including Manufacturing, Quality Assurance, R&D, Engineering, Regulatory Affairs, Supplier Quality, and management.
- May interact with health authorities, notified bodies, customers, corporate auditors, suppliers, and consultants within assigned responsibilities.
Base salary for this position is a minimum of $125,000 and a maximum of $148,000 plus annual bonus of 10%.
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