Principal Quality Engineer (Wayne, NJ)

Getinge•Wayne, NJ

99d•$140 - $165

About The Position

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.

Requirements

Bachelor’s Degree in Science or Engineering or equivalent combination of education and experience.
A minimum of 7 years’ experience in design controls, related experience in QA in a Medical Device manufacturing environment. Sterile disposable experience a plus.
Knowledge of process, equipment and software validation.
Previous background and experience in Quality Assurance and Manufacturing.
Strong knowledge and experience in 21 CFR part 820, ISO 13485 and other related regulatory requirements.
Successful interactions and experience with regulatory agencies.
Good knowledge of statistics and practical application of the QSR and ISO 13485.
Solid Project Management and Leadership experience is required.
Experience in FDA regulated industry or ISO certified organization.
Demonstrated proficiency in Statistical analysis, ability to analyze and solve complex problems, proficient with analytical software applications and the ability to communicate effectively across departments, with R&D and Manufacturing.
Experience in design controls, sustaining engineering, and post-market surveillance.
Experience in risk management, including FMEA and maintaining product risk files.
Strong problem-solving skills with experience in root cause analysis and CAPA.
Experience with regulatory audits and inspections (FDA, Notified Body, MDSAP, etc.)
Strong knowledge of ISO 13485, FDA 21 CFR Part 820, 21 CFR 806, ISO 14971, IEC 62304, MDR 2017/745, and other global regulatory requirements.
Experience with sterile and electro-mechanical medical devices, including applicable standards (ISO 11135, ISO11607-1, IEC 60601).
Experience in conducting and participating in FDA/Customer/corporate audits.
Excellent leadership, communication, and cross-functional collaboration skills.
Proficiency in using tools like MINITAB, SAP or equivalent software applications.

Nice To Haves

A Master’s of Science in Engineering, Science or related field is preferred.
Sterile disposable experience a plus.

Responsibilities

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 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). Ensure any new risks identified in this effort are reflected in the Risk Management File in a timely manner.