Manager Quality Compliance - Wayne, NJ

Getinge•Wayne, NJ

About The Position

The Manager, Quality Compliance is responsible for leading the Cardiac Surgery/Vascular Intervention Quality Compliance group. This position will have a responsibility for providing support for maintenance of quality systems, Internal audit program, CAPA process, management of 3rd party audits (FDA, ISO, other), FDA inspection response to 483 observations and periodic updates. This position partners with Quality leaders as well as representatives/leaders from the other cross functional groups on Quality Management System improvements. Develops and manages the department to assess and ensure compliance to the FDA QMSR (Quality Management System Regulations Part 820), ISO 13485 Quality System Standard, MDD, CMDR, WHLW, ANVISA, JPAL and other applicable regulations. The position will lead the quality compliance team and coordinates efforts to effectively maintain quality system to the applicable regulations and standards.

Requirements

A Bachelor’s Degree in Engineering, Science, or other related field or equivalent combination of education and related work experience is required.
A minimum of ten years of experience in quality assurance, quality compliance, or related functions in an FDA regulated industry or ISO certified organization is required.
A minimum of ten years related experience managing quality systems and implementing Quality Management systems in the medical device or pharmaceutical or related industry is preferred.

Nice To Haves

A Master’s of Science (or related field) or MBA is a plus. ASQ, CQE, greenbelt or other applicable certifications are a plus.

Responsibilities

Build and lead an accountable Quality Systems organization
Develop a competent and accountable team to deliver quality systems excellence and business objectives while maintaining compliance with applicable standards, laws, and guidance.
Coach and develop direct reports; ensure clear goals, role clarity, training, succession planning, and performance management.
Promote a Quality culture that reinforces personal accountability for compliance, accuracy, consistency, and completeness across functions.
Ensure QMS processes are effectively established, implemented, and maintained in alignment with FDA QMSR (Part 820), ISO 13485, and applicable global regulations.
Serve as site leader for QMS governance, including procedure standards, process performance, escalation pathways, and continuous improvement.
Drive audit readiness as an “operating state,” ensuring QMS evidence quality, consistent execution, and timely remediation of gaps.
Responsible for directing the day-to-day operations of key quality system processes such as:
CAPA Excellence (governance + effectiveness):
Ensure CAPA processes drive high-quality root cause analysis, robust containment, meaningful corrective/preventive actions, and effective effectiveness checks.
Lead or chair routine CAPA triage/aging reviews with clear SLAs, escalation, and cross-functional accountability.
Risk Management:
Ensure risk management standards and execution are robust, including linkages between risk files, controls, verification evidence, and post-market signals.
Establish routine risk review cadence incorporating complaint/PMS trends and CAPA learnings.
Audit:
Manage internal audit program planning, execution quality, and follow-up; ensure independence and strong corrective action closure.
Assists with third party quality systems inspections and audits (i.e. FDA, ISO, corporate, etc.)
Coordinate responses to External Audits (i.e. FDA Inspection, Corporate Audits, Notified Body, etc.)
Quality Planning, Data, Metrics, and Management Review:
Own KPI definitions and dashboards for the pillars; ensure management review inputs are accurate, risk-based, and action-oriented.
Manage the process for Quality Planning to ensure implementation.
Ensure that the conformity of the devices is appropriately checked, in accordance with the Quality Management System under which the devices are manufactured, before a device is released.(To comply with Article 15 of European Union Medical Device Regulation (EU MDR) (Regulation (EU) 2017/745 of the European Parliament and of the council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC).