Senior Quality Engineer
ResponsibilitiesLocation Singapore, SG Job ID AMS-LSDx-JR-0116
Imagine a world where you could detect health issues sooner to treat them more effectively. Where food and water are always safe, even in remote corners of the earth. And where scientific and medical research are enhanced to solve the greatest challenges of our times. At PerkinElmer, we imagine this world every day.
PerkinElmer’s commitment to scientific innovation is at the heart of everything we do. Our dedicated team of 16,000 employees worldwide pioneers scientific technologies for better detection, imaging, and informatics to help our customers create healthier families, make smarter decisions, earlier diagnoses, more effective treatments and scientific breakthroughs globally.
Work with cross-functional teams to ensure implementation and/or maintenance of QMS that are appropriate for Medical Devices / Life Sciences Manufacturing / Medical Devices Distribution and Services, complies with FDA 21 CFR Part 820, ISO 9001, ISO 13485, GDPMD and other applicable regulatory and statutory requirements.
Coordinate, plan and manage audits (internal/cross-sites).
Facilitate external audit by certification body and support regulatory inspections by regulatory agencies e.g. US FDA.
Perform internal audits of processes, facilities and documentation to assure compliance with internal procedures, FDA 21 CFR Part 820, ISO 9001, ISO 13485 and GDPMD regulations and requirements.
Establish, maintain and update relevant QMS documentation.
Coordinate the Quality Management Review meeting on scheduled basis and prepares metrics and reports.
Maintain calibration records for all manufacturing tools and equipment.
LMS administrative role for local procedure and practice.
Interface with production, process, and test engineering to ensure that products are consistently produced and controlled as per ISO / Part 820 requirements
Provide QA support in the design, development, sustaining and production of life science / medical device products, facilitating the application of change controls, inspection and testing, risk management activities and quality plan for new product introductions / existing products are in order to sustain product competitiveness while maintaining compliance to domestic and international regulations and standards.
Conduct customer feedback/complaints and trend review, and drive appropriate continual improvement implementation.
Support all Quality compliance and regulatory activities.
Bachelor’s Degree in Quality, Engineering, Biomedical Engineering, Life Sciences or relevant disciplines.
At least 5 year(s) of relevant working experience in development and maintenance of quality management system compliance, preferably in a medical devices/healthcare manufacturing environment.
Strong knowledge in US FDA 21 CFR Part 820 Quality System Regulation, Quality System (e.g. ISO13485, ISO 9001, GDPMD). IVD experience is highly preferred.
QMS Lead auditor certification preferred.
Participation in previous FDA site inspections is advantageous.
Strong knowledge in GDPMD, ISO9001, ISO13485, FDA 21CFR820.
Broad working knowledge of QMS ISO 13485 regulations, ISO 14971 and basic understanding of medical device manufacturing process.
Knowledge of computer software like SAP, Microsoft Office applications etc.
High proficiency in MS Office (Excel, Powerpoint, Access, etc).
Organized, detail-oriented, and able to multi-task and prioritize responsibilities.
Experience in medical device / healthcare engineering and manufacturing environments preferred.
PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
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