Senior Design Quality Engineer
1 week ago
Growth opportunities abound in this hybrid role, offering 60% work from home flexibility. Our client, a leading developer of innovative medical devices in Oncology and other specialized fields, is committed to advancing healthcare through high-quality, reliable, and cutting-edge solutions.
Job SummaryWe are seeking a seasoned Senior Design Quality Engineer to join our team and play a critical role in ensuring our products meet the highest standards of safety and effectiveness.
Key Responsibilities- Lead and support design control activities, including design inputs, design outputs, design reviews, verification and validation, and design transfer, to ensure compliance with FDA regulations and ISO 13485 standards.
- Oversee risk management processes, including Hazard Analysis and Critical Control Points (HACCP), Failure Mode and Effects Analysis (FMEA), and Fault Tree Analysis (FTA), to identify, assess, and mitigate potential risks associated with medical device design and development.
- Ensure all design and development activities adhere to applicable regulatory requirements and industry best practices, preparing and reviewing documentation for regulatory submissions and audits.
- Develop, implement, and monitor quality assurance processes and procedures, conducting and managing internal and external audits to ensure adherence to quality standards.
- Cross-functional collaboration with R&D, Manufacturing, and other departments to integrate quality considerations into the design process, providing guidance and support to teams on quality issues and best practices.
- Create and maintain comprehensive design history files (DHFs), including design plans, risk management files, and validation reports, and prepare and present quality metrics and reports to management.
- Lead and participate in continuous improvement initiatives aimed at enhancing product quality and process efficiency, identifying and implementing best practices and lessons learned from previous projects.
- Bachelor's degree in Engineering, Biomedical Engineering, or a related field; Master's degree or advanced certification (e.g., CQE) is a plus.
- Minimum of 7-10 years of experience in quality engineering within the medical device industry, with a strong focus on design controls and regulatory compliance.
- In-depth knowledge of FDA regulations, ISO 13485, and other relevant standards, proficiency in design control processes, risk management methodologies, and quality assurance practices.
- Excellent analytical and problem-solving skills, with the ability to navigate complex issues and develop effective solutions.
- Strong written and verbal communication skills, with the ability to interact effectively with cross-functional teams and external stakeholders.
- Proven leadership abilities, with experience mentoring and guiding junior engineers and quality professionals.
- Compensation up to $120,000
- 6% 401K match
- 10% Bonus
- 3 weeks PTO
- Health, Dental and Vision (BCBS)
- Hybrid work schedule
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