Senior Design Assurance Engineer

• Lead quality activities including risk assessments, device testing, validations, audits, and technical documentation.
• Manage Design History File (DHF) and support continuous improvement of the QMS.
• Ensure product development and risk management activities comply with company procedures and 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.

Collins McNicholas