Quality Assurance Lead for Medical Devices
3 weeks ago
We are seeking an experienced Quality Assurance Lead to join our team at Trexo Robotics. As a Quality Assurance Lead, you will play a critical role in ensuring the quality of our medical devices and adhering to regulatory requirements.
Key Responsibilities:- Develop and Implement Quality Management Systems (QMS): Design, implement, and maintain QMS processes to ensure compliance with FDA, Health Canada, EU MDR, and other relevant regulations.
- Lead Quality Initiatives: Manage and oversee the development, documentation, and improvement of QMS procedures, including CAPA, Change control, NCR, PMS, complaint handling, and risk management activities.
- Collaborate with Cross-Functional Teams: Work closely with engineering, supply chain, business operations, and manufacturing teams to ensure seamless integration of quality assurance into product development and manufacturing.
- Analyze and Interpret Data: Use analytical skills to interpret data and trends, identifying areas for improvement and implementing corrective actions as needed.
Requirements:
- Bachelor's degree in a related field (e.g., Engineering, Life Sciences) or equivalent experience.
- Minimum 5 years of demonstrated success in a quality-related role for a medical device company with a product on the market.
- Certification in Quality (e.g., CQPA, ASQ) is highly desirable.
- Proficient understanding of quality management systems, regulatory requirements, and quality tools/methodologies.
What We Offer:
- A competitive salary range of $110,000 - $140,000 per annum, based on experience.
- Opportunities for professional growth and development in a dynamic industry.
- A hybrid work environment (3 days in-office) following initial onboarding.
- Unlimited vacation policy.
- Snacks in the office.
- Dog-friendly office.
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