Quality Assurance Engineer Lead
hace 6 días
We are a leader in medical science for over 40 years, driven by a deep caring for human life. Our mission is to advance science for life, transforming lives through innovative medical solutions that improve patient outcomes and create value for our customers.
Estimated Salary: $120,000-$180,000 per yearThis role will oversee the sustaining activities for our Single Use Devices for the rapidly growing Electrophysiology division. You will have direct interaction with our Heredia and Arden Hills sites, as well as working closely with our Montreal and Waltham design sites.
Job Description:We are seeking an experienced Quality Assurance Engineer Lead to provide Design Assurance Engineering support to Arden Hills and Heredia for commercial products in the market. This role will also support development products, ensuring delivery of the highest quality results to customers while driving continuous improvement projects and quality initiatives.
- Demonstrate knowledge and application of Design Assurance, Risk Management, and Post-Market Surveillance principles.
- Owning quality system NCEPs, CAPAs, and project plans relating to Design Assurance and Risk Management.
- Apply sound problem-solving methodologies to identify, prioritize, communicate, and resolve issues.
- Establish and cultivate business relationships to facilitate completion of assignments.
- Bachelor's degree in Electronic, Industrial, Electromechanical Engineering or related field.
- English language proficiency level desired: 80-89%.
- At least 3 years of experience in similar positions.
- Influence across functional teams (manufacturing engineering, post-market complaints, CAPA, risk management, supplier quality, and process engineering) and drive projects to completion.
- Familiarity with FDA, ISO, MDD, and medical device industry quality requirements associated with product design & development and product risk management.
- Ability to work in a fast-paced, dynamic environment while promoting / fostering cross-functional teamwork.
- Life-Work Integration
- Community
- Career Growth
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