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Quality Assurance Specialist III
hace 1 mes
Company Overview
">Boston Scientific is a leading medical device company committed to advancing science for life. With over 40 years of experience, we are dedicated to solving the challenges that matter most – united by a deep caring for human life.
">About the Role
">This position will oversee sustaining activities for our Single Use Devices in the rapidly growing Electrophysiology division. You will work closely with our Heredia and Arden Hills sites, as well as Montreal and Waltham design sites.
">Responsibilities
">- ">
- Demonstrate knowledge and application of Design Assurance, Risk Management, and Post-Market Surveillance.">
- Owning quality system NCEPs, CAPAs, and project plans relating to Design Assurance and Risk Management.">
- Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues.">
- Navigating grey spaces and providing logical and creative ideas to teams.">
- Establishing business relationships to facilitate assignments completion.">
- Working with internal customers representing related processes such as Design Controls, Risk Management, Post Market Surveillance, Clinical, Medical Safety, Regulatory, and Complaint handling.">
Requirements
">We require a Bachelor's degree in Electronic, Industrial, Electromechanical Engineering or a related field. At least 3 years of experience in similar positions is needed.
">Preferred Qualifications
">- ">
- Influencing across functional teams (manufacturing engineering, post market complaints, CAPA, risk management, supplier quality, and process engineering).">
- Driving projects to completion.">
- Familiarity with FDA, ISO, MDD, and medical device industry quality requirements.">
- US and International regulations understanding including 21 CFR, 820, 210, 211, and 11.">
- Medical Device Directive, EN ISO 13485, and EN ISO 14971 knowledge.">
Benefits
">We offer a competitive salary range of $120,000 - $160,000 per year, depending on experience. Our benefits package includes Life-Work Integration, Community, and Career Growth opportunities.
">Why Join Us?
">Boston Scientific is a place where you can find a career with meaningful purpose—improving lives through your life's work. We value diversity, innovation, and collaboration.
">Location
">This role is based in Boston, Massachusetts. As a global company, we also have opportunities for remote work.
