Quality Engineer

Posted 2 Days Ago
Be an Early Applicant
Singapore
Entry level
Biotech
The Role
The Quality Engineer is responsible for overseeing customer quality, managing product and process quality, supporting the quality management system, ensuring regulatory compliance, managing supplier quality, and collaborating across functions to address quality issues and improve processes.
Summary Generated by Built In

Job TitleQuality Engineer
Location(s)
Singapore

About Us

Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world’s greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our diverse team of 11,000+ colleagues from around the globe are vital to our success and the reason we’re able to push boundaries in pursuit of better human health.

Find your future at Revvity 

  • Customer Quality Management: Overseeing all aspects of customer quality, including
    • Collaborating closely with the Complaint Handling Unit (CHU) team to address customer complaints promptly and effectively.
    • Conducting product technical reviews and updating Post Market Surveillance Reports to ensure compliance with regulatory requirements and address any quality-related issues identified.
  • Product and Process Quality Management: Responsible for ensuring manufacturing processes adhere to quality standards and specifications. This entails:
    • Monitoring process performance and conducting audits to identify areas for improvement.
    • Implementing enhancements to elevate product quality and consistency.
    • Overseeing the release of finished goods to ensure compliance with quality standards.
    • Managing qualification processes for tools, equipment, and software to guarantee they meet quality requirements.
  • Quality Management System (QMS) : Supporting various aspects of the quality management system, including
    • Internal Audit: Plan, conduct, and follow up on the internal audit closure
    • External Audit: Support external audit activity
    • Manage and coordinate the TUV regular site inspection.
    • corrective and preventive actions (CAPA), change control, and risk management. This may involve developing and maintaining QMS procedures and ensuring compliance with relevant standards and regulations.
  • Regulatory Compliance: Ensuring compliance with regulatory requirements and standards which shall include, but not limited to ISO9001, ISO13485, IVDR, and QSR820 as applicable to the product and manufacturing processes.
  • Supplier Quality Management: Backup to support the Supplier Quality Engineer and collaborating with suppliers to ensure the quality of incoming materials and components.
  • New Product Development: Manage quality deliverables in NPI projects, including the creation of control documentation, establishing process control, and training of quality inspectors, if any.
  • Cross-functional Collaboration: Working closely with cross-functional teams, including engineering, manufacturing, procurement, and customer service, to address quality- related issues, drive quality improvements, change control management, and support overall business objectives.
The Company
Waltham, , Massachusetts
3,109 Employees
On-site Workplace
Year Founded: 2023

What We Do

At Revvity, “impossible” is inspiration, and ""can't be done"" is a call to action. Revvity provides health science solutions, technologies, expertise and services that deliver complete workflows from discovery to development, and diagnosis to cure. Revvity is revolutionizing what’s possible in healthcare, with specialized focus areas in translational multi-omics technologies, biomarker identification, imaging, prediction, screening, detection and diagnosis, informatics and more. With more than $3 billion in revenue and over 11,000 employees, Revvity serves customers across pharmaceutical and biotech, diagnostic labs, academia and governments. It is part of the S&P 500 index and has customers in more than 190 countries. Learn more at www.revvity.com

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