Principal Quality Engineer; Wayne, NJ

Position: Principal Quality Engineer (Wayne, NJ)
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 primary purpose of this position is to lead, develop, establish, and maintain quality engineering policies, processes, procedures and controls ensuring that design, development, performance and quality of products conform to internal specifications and established standards. Coordinates with stakeholders in R&D and Manufacturing to assure design quality and accuracy in both new and sustaining product development.

Responsible to manage and maintain product Risk Files. Leads Health Hazard Evaluations (HHEs) to help assess product performance risk to enable appropriate Field Action decisions. Maintains oversight and upkeep of Field Action Plans.

Job Responsibilities and Essential Duties
* Define, maintain, and revise processes, and QMS procedures to ensure company and products comply with applicable regulations and laws. Specifically for Design Controls, Risk Management, HHE, Field Actions and Test Method Validations.
* Provide guidance throughout product development lifecycle focusing on areas of Design Controls and Risk Management, ensuring compliance to 21 CFR 820 and ISO 13485.
* Review Design Input, Output and verification artefacts to ensure Customer Requirements are translated to feasible technical solutions with an acceptable risk.
* Provide quality oversight during new product development (NPD) and design changes, ensuring risk-based decision-making.
* Support design verification and validation (V&V) activities, including test method validation, failure investigations, and nonconformance resolution. Oversee validation of software used in medical devices (embedded, standalone, SaMD). Review and approve software validation *

plans, protocols, and reports to ensure regulatory compliance and product safety. Work with cross-functional teams to assess the impact of software changes, patches, and updates on device safety and performance.
* Support and Lead (when appropriate) product quality investigations, driving root cause analysis and corrective actions.
* Provide support to project teams in the use of data analysis tools such as DFSS and DOE. Lead effort in data driven decision making activities.
* Establish, implement, and maintain a comprehensive Risk Management process in accordance with ISO 14971 and global regulatory requirements.
* Own and manage product risk files, ensuring continuous updates throughout the product lifecycle.
* Partner with R&D and Regulatory teams to ensure risk-benefit analysis aligns with regulatory submissions and post-market feedback.
* Drive Failure Modes and Effects Analysis (FMEA) sessions to proactively identify and mitigate design, process, and use-related risks.
* Lead the Health Hazard Evaluation (HHE) process, ensuring thorough risk assessment for field issues, complaints, and potential recalls.
* Drive decision-making for field actions, including recalls, corrections, and removals, in compliance with global regulatory expectations.
* Work cross-functionally with Regulatory, Medical Affairs, and Legal teams to develop risk mitigation strategies and regulatory submissions for field actions.
* Support internal and external audits, including FDA, Notified Body, and MDSAP audits, ensuring a state of continuous inspection readiness.
* Monitor the effectiveness of document control & records control processes are developed and maintained.
* Establish quality metrics and KPIs (for processed under assigned responsibility) to track product/process performance and effectiveness of quality initiatives (when applicable).
* Identify and lead continuous improvement projects and CAPAs and HHE's. Ensure adequate follow-up through the implementation of corrective and preventive actions as appropriate.
* 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 05 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).

* Collaborate with post-market surveillance teams to assess field performance and identify opportunities for product improvements.
* Support post-market surveillance activities to ensure compliance with Article 10(10) of European Union Medical Device Regulation (EU MDR) (Regulation (EU) 2017/745 of the European Parliament and of the council of 05…