Principal Quality Engineer (Wayne, NJ)

Getinge • Wayne, NJ

78d • $140,000 - $165,000

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 Master’s of Science in Engineering, Science or related field is preferred.
• A minimum of 7 years’ experience in design controls, related experience in QA in a Medical Device manufacturing environment.
• Knowledge of process, equipment and software validation.
• Strong knowledge and experience in 21 CFR part 820, ISO 13485 and other related regulatory requirements.
• Good knowledge of statistics and practical application of the QSR and ISO 13485.

Nice To Haves

• Sterile disposable experience.
• Experience in FDA regulated industry or ISO certified organization.
• Demonstrated proficiency in Statistical analysis.
• Experience in risk management, including FMEA and maintaining product risk files.
• Experience with sterile and electro-mechanical medical devices.

Responsibilities

• Define, maintain, and revise processes, and QMS procedures to ensure company and products comply with applicable regulations and laws.
• Provide guidance throughout product development lifecycle focusing on areas of Design Controls and Risk Management.
• 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.
• 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.
• Support and Lead 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.
• Establish, implement, and maintain a comprehensive Risk Management process in accordance with ISO 14971.
• 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.
• 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.
• Drive decision-making for field actions, including recalls, corrections, and removals.
• Work cross-functionally with Regulatory, Medical Affairs, and Legal teams to develop risk mitigation strategies.
• Support internal and external audits, ensuring a state of continuous inspection readiness.
• Monitor the effectiveness of document control & records control processes.
• Establish quality metrics and KPIs to track product/process performance.
• Identify and lead continuous improvement projects and CAPAs and HHE’s.
• Ensure that the conformity of the devices is appropriately checked before a device is released.
• Collaborate with post-market surveillance teams to assess field performance and identify opportunities for product improvements.

Benefits

• Salary Range: $140-165k plus 15% bonus (depending on overall company performance).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees