We are seeking an experienced Design Assurance Engineer to lead quality activities, manage design history files and support the continuous improvement of our QMS.
Key Responsibilities:
* Lead quality initiatives including risk assessments, device testing, validations, audits and technical documentation.
* Manage Design History File (DHF) and support the advancement of our Quality Management System (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.
Essential Skills & Experience:
* 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.