Senior Design Assurance Engineer Position
2 weeks ago
We are seeking a skilled Design Assurance Engineer to join our team. In this role, you will play a crucial part in ensuring the quality and reliability of our medical devices.
Key Responsibilities:- Lead quality activities including risk assessments, device testing, validations, audits, and technical documentation.
- Manage Design History File (DHF) and support continuous improvement of the Quality Management System.
- Ensure product development and risk management activities comply with regulatory requirements.
- Translate user needs into design and manufacturing requirements, including test method development and process monitoring.
- Conduct design verification, validation, and test method validation.
- Collaborate with R&D, Manufacturing, suppliers, and external stakeholders to resolve issues and ensure quality standards are met.
- Apply problem-solving and statistical analysis techniques to product development and manufacturing processes.
- Represent the medical device client professionally to regulators, vendors, and auditors.
- Support compliance activities such as CAPA, audits, and training.
- Review and approve operational, test, and validation data to confirm product conformance.
- Provide quality guidance, mentorship, and technical support to staff.
- Bachelor's degree in Engineering, Science, or related technical field.
- Minimum 6 years of QA, Quality Systems, or regulatory experience in the medical device industry, including at least 4 years in design and development QA.
- Strong knowledge of FDA 21 CFR Part 820 (QMSR), ISO 13485:2016, EU MDR, Canadian MDR, and related international regulations.
- Experience supporting audits, inspections, and regulatory interactions.
- Strong project management, leadership, and communication skills.
- Proficiency in MS Office and statistical tools (e.g., Minitab).
- Results-driven, self-motivated, with strong decision-making and problem-solving skills.
This role offers a challenging and rewarding career opportunity for a motivated individual who is passionate about quality and innovation.
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