Senior Quality Engineer, Quality Operatons; Wayne, NJ

Senior Quality Engineer, Quality Operatons (Wayne, NJ)

Date:
Jan 9, 2026

Location:

Wayne, NJ, US

Company:
Datascope Corp.

Remote Work: 1-2 days at home (site based)

Salary Range: $112k-$125k plus 10% bonus (depending on overall c)

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

As a Sr. Quality Engineer specializing in Quality Operations, you will be responsible for overseeing and improving the quality of manufacturing processes, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives to enhance product quality and customer satisfaction. You will play a key role in ensuring that our manufacturing operations meet the highest standards of quality and efficiency while adhering to relevant regulations and industry best practices.

• 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.

• Bachelor’s Degree in Engineering, Science, or other related field is required. ASQ, CQE, Six Sigma Green Belt or other applicable certifications are a plus.
• Minimum 6 years’ experience in Quality or Engineering.
• Experience in a medical device or pharmaceutical industry.
• Experience with Class III disposable and/or Electro-Mechanical medical devices is preferred.
• Knowledge and understanding of the US Food and Drug Administration (FDA) 21 CFR 820, ISO 13485, ISO 14971, EU MDD, and EU MDR. Knowledgeable on specific requirements for Design Controls and Risk Management is…