Principal Design Quality Assurance Specialist
4 weeks ago
About the Role:
We are seeking a Principal Design Quality Assurance Specialist to join our team at Beckman Coulter Life Sciences.
Job Overview:
This is a challenging and rewarding opportunity for a highly motivated and detail-oriented individual to lead quality assurance efforts in design control, ensuring compliance with regulatory requirements and industry standards.
About Us:
Beckman Coulter Life Sciences is a leading global provider of life sciences solutions, empowering researchers and scientists to accelerate discoveries and drive breakthroughs.
Responsibilities:
- Ensure Design Control Process Compliance: Oversee and implement design control processes throughout the product lifecycle, ensuring adherence to ISO 13485, GMP, and other relevant regulations.
- Guide Product Design Control Process: Provide guidance and support to cross-functional teams on product design control process and risk management process.
- Review and Approve DHF: Conduct thorough reviews of Device History Files (DHF) to ensure accuracy, completeness, and compliance.
- Establish QMS: Develop and maintain a robust Quality Management System (QMS), ensuring full compliance with regulatory requirements.
- Monitor Performance: Analyze data to monitor design control process performance and identify areas for improvement.
- Lead Quality Improvement Projects: Drive quality improvement initiatives to enhance process effectiveness and ensure product safety.
- Offer Quality Training: Provide training and development opportunities to improve knowledge and skills of team members.
Requirements:
- Bachelor's/Master's Degree: Educational background in biotechnology, medicine, laboratory science, biology, immunology, or pharmacy-related majors.
- Experience: At least 7+ years in reagent development, test, or quality assurance experience supporting new project launch or design changes. At least 3 years' experience in reagent design and development quality assurance role.
- Quality Knowledge: Understand principles and testing methods of IVD products, familiar with ISO 13485, GMP, and related quality management systems.
- Language Skills: Fluent in English speaking.
Preferred Qualifications:
- CAPA/Risk Management: Experience with CAPA and risk management processes.
- System Level Core Team QA Support: Familiarity with hardware, software, reagent, and combination-level core team QA support.
- FDA Audit Preparation: Experience with FDA audit preparation and undergone FDA audits.
What We Offer:
A competitive salary range of $120,000 - $160,000 per annum, depending on experience and qualifications.
Benefits:
An attractive benefits package, including comprehensive health insurance, retirement savings plan, and generous paid time off.
Join Lifelancer Platform:
Lifelancer (https://lifelancer.com) is a talent-hiring platform in Life Sciences, Pharma, and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, and IT domains.
How to Apply:
Please visit https://lifelancer.com/jobs/view/226f26806464c9fc592b65aa62055ade to find similar roles and apply on the Lifelancer Platform.
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