Senior Design Assurance Engineer
The role of Senior Design Assurance Engineer is to be the QA technical and compliance expert as part of a cross‑functional team for the design and development of sterile and non‑sterile medical devices and subsequent modifications in compliance with regulatory requirements (ISO 13485, CFR 820, and other governing standards).
Key Responsibilities
* Lead device testing and validation activities.
* Perform internal and external audits; provide SME support for design processes.
* Generate and approve technical documents on behalf of the Quality Function.
* Drive continuous improvement of the QMS.
* Conduct risk assessments and manage the Design History File (DHF).
* Ensure compliance with product development and risk management activities.
* Translate user requirements into design requirements and contribute to risk management documentation.
* Complete design verification, validation, and test method validation.
* Work with R&D and Manufacturing Engineering on translating design into manufacturing requirements, developing manufacturing test methods, and implementing production process monitoring.
* Lead resolution of project issues and apply systematic problem‑solving methodologies.
* Monitor compliance with medical policies, procedures, and regulatory requirements, and implement process improvements.
* Apply quality tools, statistical techniques, and analysis.
* Represent the company to external agencies, vendors, and regulators.
* Lead compliance and improvement activities (CAPA, audit programs, training).
* Plan, execute, report, and follow‑up on quality system audits.
* Make decisions aligned with management objectives to achieve quality goals.
* Track and report progress across projects and develop performance metrics.
* Generate, review, and approve operational, test, and validation data for equipment, materials, and final products.
* Provide technical quality guidance, including mentoring of junior staff.
* System administrator for Minitab.
* Ensure compliance with the QMS per QM001 quality manual.
Qualifications
* Minimum Bachelor's Degree in Engineering, Science or related technical field.
* At least 6 years QA, quality system, or regulatory experience in the medical industry; minimum 4 years in QA activities related to product design and development, including project management and leadership.
* In‑depth knowledge of FDA 21 CFR Part 820, ISO 13485:2016, EU MDR, Canadian MDR, and other international standards.
* Results and deadline driven, able to handle multiple tasks in a fast‑paced environment.
* Excellent interpersonal and communication skills; proficiency in English and MS Office.
* Experience preparing for notified‑body and FDA inspections and participating in audits.
* Good judgment and decision‑making with understanding of impacts on company and customers.
* Highly motivated self‑starter, capable of working independently and as a team player.
* Good business acumen.
Seniority Level
Mid‑Senior level
Employment Type
Full‑time
Job Function
Quality Assurance
Industry
Staffing and Recruiting
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