Principal Quality Engineer; Wayne, NJ

Overview

Getinge is a leading provider of life-saving technology. This role is based in Wayne, NJ with a hybrid schedule: 4 days/week in Wayne and 1 remote day.

Location:

Wayne, NJ, US. Remote Work: 1-2 days at home (site based). Salary Range: $140,000 - $150,000 plus annual bonus of 15%.

Principal Quality Engineer (Wayne, NJ)

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

• 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.

• Bachelor’s degree in Engineering, Science, or equivalent (required). Master’s in Engineering/Science (preferred).
• 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).
• CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) certification (preferred).
• Subject Matter Expertise required in at least one of the following areas:
• CAPA systems & root cause methodologies (5 Whys, Fishbone, Shainin, Fault Tree, etc.)
• 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. Previous experience supervising technicians and conducting and leading FDA/customer/corporate audits is preferred.
• 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., Track Wise, Windchill, SAP, Minitab).

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

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