Getinge · 13 hours ago
Senior Quality Engineer, Quality Operatons (Wayne, NJ)
Wayne, NJ
Full-time
Onsite
Mid, Senior Level
$112K/yr - $125K/yr
6+ years expGetinge is a company dedicated to making life-saving technology accessible for more people. As a Senior Quality Engineer specializing in Quality Operations, you will oversee and improve the quality of manufacturing processes, ensuring compliance with regulatory requirements while driving continuous improvement initiatives to enhance product quality and customer satisfaction.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Develop, implement, and maintain quality control processes and procedures for manufacturing operations to ensure compliance with regulatory requirements and industry standards
Establish and monitor key performance indicators (KPIs) to assess manufacturing quality and identify opportunities for improvement
Participate/ Lead validation and verification activities for manufacturing processes, equipment, and software systems to ensure they meet quality and regulatory requirements
Develop/ review validation protocols, execute validation studies, and analyze data to ensure process robustness and reliability
Ensures through Design Transfer activities the Device Master Records (DMRs) contents are developed, controlled, and maintained leading to Risk based Manufacturing Control Plans
Support/ Investigate and resolve Out of Tolerance events identified during equipment/ instrument calibrations
Investigate product nonconformances, conduct root cause analysis, and implement corrective and preventive actions (CAPA)
Track and monitor CAPA effectiveness to ensure issues are resolved and prevented
Support the Health and Hazard Evaluation process by gathering required data and performing in-depth analysis prior to sharing the information with the Field Action Committee
Implement corrective and preventive actions (CAPAs) to address root causes and prevent recurrence of quality issues
Facilitate risk management activities related to manufacturing processes, identifying, and mitigating risks to product quality, safety, and efficacy
Implement risk-based decision-making processes to prioritize quality activities and allocate resources effectively
Lead and support continuous improvement projects aimed at enhancing manufacturing processes, reducing defects, and optimizing productivity
Utilize quality tools and methodologies, such as Six Sigma, Lean Manufacturing, and Statistical Process Control (SPC), to drive process optimization and waste reduction
Ensure compliance with applicable regulations, including FDA Quality System Regulation (QSR), ISO 13485, and other international standards
Support both internal and external audits as an SME for Production & Process Controls and presents records of activities related to Design Transfer for New Product Development and Design Changes
Provide mentorship and guidance to new Engineers/Interns within the organization
Qualification
Required
Bachelor's Degree in Engineering, Science, or other related field is required
Minimum 6 years' experience in Quality or Engineering
Experience in a medical device or pharmaceutical industry
Knowledge and understanding of the US Food and Drug Administration (FDA) 21 CFR 820, ISO 13485, ISO 14971, EU MDD, and EU MDR
Knowledge of application & selection of Sampling Plans, to support Risk based Manufacturing Controls Plans
Strong analytical and problem-solving skills
Excellent communication and interpersonal skills
Ability to work effectively in a cross-functional team environment
Ability to review and understand technical standards and their requirements for products
Preferred
ASQ, CQE, Six Sigma Green Belt or other applicable certifications are a plus
Experience with Class III disposable and/or Electro-Mechanical medical devices is preferred
Knowledgeable on specific requirements for Design Controls and Risk Management is preferred
Project management and leadership experience is desirable
Knowledge of Microsoft Office Products such as Word, Excel, or equivalent software applications
Proficiency in quality tools and methodologies (e.g., Six Sigma, FMEA, Gage R&R)
Office and manufacturing/ warehouse floor settings with occasional exposure to test laboratory environments
May work extended hours during peak business cycles
Benefits
Health, Dental, and Vision insurance benefits
401k plan with company match
Paid Time Off
Wellness initiative & Health Assistance Resources
Life Insurance
Short and Long Term Disability Benefits
Health and Dependent Care Flexible Spending Accounts
Commuter Benefits
Parental and Caregiver Leave
Tuition Reimbursement
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
Recent News
News Powered by Cision
2025-12-19
Company data provided by crunchbase