Getinge · 1 day ago
Principal Quality Engineer (Wayne, NJ)
Wayne, NJ
Full-time
Hybrid
Senior Level, Lead/Staff
$140K/yr - $150K/yr
7+ years expGetinge is a company dedicated to making life-saving technology accessible for more people. The Principal Quality Engineer plays a critical role in supporting audits and enhancing product reliability and regulatory compliance within an FDA-regulated manufacturing environment, overseeing quality control operations and leading design and validation activities.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Hiring Manager
Lauren Guapisaca
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
Qualification
Required
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
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)
Preferred
Master's in Engineering/Science
CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) certification
Familiarity with analytical software applications
Previous experience supervising technicians and conducting and leading FDA/customer/corporate audits
Company
Getinge
Getinge identifies customer issues and promotes clinical and economic benefits and follow and support the customer decision process.
10001+ employees
H1B Sponsorship
Getinge has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (2)
2022 (2)
2021 (2)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$539.31M2017-10-19Post Ipo Equity· $539.31M
2002-06-28IPO
Leadership Team
C
Christoffer Å.
Chief Information Security Officer
Joanna Engelke
EVP Quality Compliance, Regulatory, Medical
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2025-12-19
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