Design Quality Assurance Manager
1 week ago
As a key member of the Thermo Fisher Scientific team, you will play a critical role in ensuring the quality and integrity of our products. We are seeking a highly skilled Design Quality Assurance Manager to lead our design control and new product development lifecycle.
Key Responsibilities:- Lead and support design control activities, providing guidance to project core teams on user and product requirements, functional specifications, design verification and validation, risk management, design reviews, design changes, and design transfer.
- Ensure activities are conducted in compliance with all applicable regulatory requirements, international standards, and internal procedures.
- Actively identify and lead initiatives toward continuous development, training, mentoring, and coaching of staff in the design quality organization.
- BS degree in engineering or a science field such as chemistry, microbiology, biology, or biochemistry.
- 7+ years of quality assurance experience (quality engineering, quality assurance, quality control, supplier quality).
- 5+ years of experience in new product introduction activities.
- 5+ years in the medical device, in-vitro diagnostics, or other regulated industry.
- Demonstrated understanding of product development lifecycles, design change and change control, product validation methodologies, design transfer, and manufacturing/production process control methodologies.
- Experience with applicable FDA, European, and other relevant clinical/regulatory requirements, and international standards, including ISO 9001, ISO 13485, ISO 14971, EU IVDR/MDR, 21CFR 820 Quality System Regulation, etc.
- Mentoring and team management.
- Competitive remuneration and annual incentive plan bonus.
- Healthcare and a range of employee benefits.
- Opportunities for career and development growth.
We are an innovative, forward-thinking organization that values integrity, intensity, involvement, and innovation. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.
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Design Quality Assurance Manager
3 weeks ago
Eugene, Oregon, United States Thermo Fisher Scientific Full timeDesign Quality Assurance ManagerThermo Fisher Scientific is seeking a highly skilled Design Quality Assurance Manager to lead all aspects of the 'end to end' design control and new product development lifecycle.Key Responsibilities:Lead and support Design Control activities, providing guidance to Project Core Teams on User and Product requirements,...
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