Principal Quality Engineer (Wayne, NJ)

Getinge•Wayne, NJ

63d•$140,000 - $150,000•Hybrid

About The Position

The Principal Quality Engineer plays a critical role in supporting audits, and impacting continuous improvement initiatives to enhance product reliability and regulatory compliance. The position ensuries product and process excellence within an FDA-regulated manufacturing environment, and it leads design and validation activities, drives resolution of technical issues, and oversees quality control operations including CAPA, TMV, and equipment qualifications. The role requires deep expertise in quality systems, risk management, and statistical analysis, along with strong project management and cross-functional collaboration skills. The position works out of the Wayne, NJ Getinge Headquarters 4 days a week, with one day of remote work.

Requirements

Bachelor’s degree in Engineering, Science, or equivalent (required).
Minimum of 7 years of experience in quality assurance, quality engineering, or related functions in an FDA-regulated manufacturing environment (M.S. + 5 years acceptable).
Subject Matter Expertise required in at least one of the following areas:
CAPA systems & root cause methodologies (5 Whys, Fishbone, Shainin, Fault Tree, etc.)
Risk management (ISO 14971, FMEA, Fault Tree Analysis)
Test Method Validation & advanced statistical techniques (Gage R&R, ANOVA, DOE)
Supplier Quality (SCARs, APQP, PPAP, incoming inspection standards)
Design Controls (21 CFR 820.30, ISO 13485)
Demonstrated proficiency in statistical analysis, the ability to analyze and solve complex problems, and the ability to communicate effectively across departments.
Strong knowledge of quality systems is required. Familiarity with analytical software applications is preferred.
Project management and leadership experience is required.
Demonstrated ability to influence change and deliver measurable process improvements.
Strong written and verbal communication skills with ability to effectively present to senior leadership.
Proficiency in Microsoft Office suite and familiarity with quality/regulatory software tools (e.g., TrackWise, Windchill, SAP, Minitab).

Nice To Haves

Master’s in Engineering/Science (preferred).
CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) certification (preferred).
Previous experience supervising technicians and conducting and leading FDA/customer/corporate audits is preferred.

Responsibilities

Lead new product design development activities in the areas of Test Method Validation (TMV), design verification and validation, inspection plans/methods, and Equipment Installation Qualification.
Drive resolution of design issues through active participation and leadership in cross-functional meetings.
Create, review, and approve product design/process qualification/validation, design/process remediation, and change control documentation.
Manage and coordinate technical validation activities, including protocol development, synchronization of interdepartmental activities, and evaluation/reporting of results.
Lead and guide Quality Control activities including Equipment Installation Qualification, TMV, and software updates.
Oversee and ensure effectiveness of Corrective and Preventive Actions (CAPA), including investigation quality, documentation completeness, timeliness, and closure effectiveness.
Present and interpret Nonconformance and quality metrics during Monthly Metrics Reviews and Quarterly Management Reviews; represent the function during third-party audits; lead Health Hazard Evaluations and nonconformance dispositions.
Plan and perform internal audits in collaboration with Quality Compliance.
Provide leadership to manufacturing for resolution of quality-related issues in daily operations.
Review and approve supplier-provided First Article Inspection (FAI) documentation.
Lead or oversee investigations of equipment Out-of-Tolerance conditions and ensure robust root cause and corrective actions.
Identify and drive implementation of continuous improvement opportunities across processes, production, QA testing, and systems.
Communicate, influence, and align quality improvement efforts with Manufacturing, QA, R&D, and Engineering leadership.
Mentor and train less experienced engineers, technicians, or interns to build organizational capability.
Perform other related duties as assigned.