Product Development Quality Assurance Specialist
4 days ago
The Design Assurance Quality Engineer III plays a vital role in ensuring the quality and compliance of new product development projects and sustaining projects for current products on the market. They develop, establish, and maintain quality-engineering methodologies, systems, and practices that meet regulatory requirements.
Your Responsibilities Will Include:- Providing quality and compliance input to project teams for project decisions and deliverables, including design change analysis, design inputs, design outputs, test methods, design reviews, design verification and validation, usability testing, software validation, process validation, and labeling.
- Supporting software verification and validation activities for new products.
- Performing risk evaluation and associated management activities related to product development, including product risk analysis and mitigation of software issues to ensure compliance with ISO 14971 and demonstrating a primary commitment to patient safety.
- Supporting product cybersecurity assessments in conjunction with a cross-functional team.
- Providing quality and compliance input for post-market product sustaining activities, such as design changes, NCEPs, CAPAs, PIRs, field signals evaluations, and field actions.
- Applying technical skills, including sound, systematic problem-solving methodologies, in identifying, prioritizing, communicating, and resolving quality issues.
- Collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
- Capable of working independently on highly specialized projects with long-range objectives.
- Building quality into all aspects of work by maintaining compliance to all quality requirements.
- Supporting internal and external regulatory audits as required.
- Bachelor's degree in Electrical Engineering, Mechanical Engineering, or a related field.
- Minimum of 6 years of medical device engineering experience.
- In-depth familiarity with FDA, ISO, MDD, EU MDR, and medical device industry quality requirements associated with product development, design controls, and product risk management.
- Strong communication and presentation skills.
- Solid technical writing skills.
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