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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.
Sr. Quality Engineer, Quality Operations - Wayne, NJ
Wayne, NJ$115K - $120K / yearPosted 1 months ago
Full-timeonsitesenior