Job Description
">
Senior Design Assurance Expert
">
The successful candidate will serve as the Quality Assurance technical and compliance expert, working within a cross-functional team to support design and development of medical devices.
">
Key responsibilities include:
">
">
* Quality-related activities including risk assessments, device testing, internal and external audits, generation and approval of technical documents, and management of Design History Files (DHF).
">
* Continuous improvement of the Quality Management System (QMS)
">
* Ensure compliance of product development and risk management activities with governing regulatory requirements.
">
* Collaborate with product development teams to translate user needs into design requirements.
">
* Execute design verification, validation, and test method validation activities.
">
* Partner with R&D and Manufacturing Engineering to translate design requirements into manufacturing specifications.
">
* Lead resolution of project issues by applying structured problem-solving methodologies.
">
* Represent the organization professionally to external agencies, vendors, and regulators.
">
* Lead and/or support compliance and improvement initiatives within the QMS.
">
">
Required Skills & Qualifications
">
A bachelor's degree in Engineering, Science, or related technical discipline.
">
Minimum of 6 years' experience in Quality Assurance, Quality Systems, or Regulatory Affairs within the medical device industry.
">
In-depth knowledge of FDA 21 CFR Part 820 (QMSR), ISO 13485:2016, EU MDR, Canadian Medical Device Regulations, and other international standards.
">
Strong problem-solving, decision-making, and analytical skills.
">
Excellent interpersonal skills with the ability to influence and collaborate effectively across teams.
">
Strong written and verbal communication skills, with fluency in English.
">">
Benefits
">
This is an opportunity to lead quality and compliance activities in medical device design, directly influencing the safety, reliability, and market success of life-changing technologies.
">">
Others
">
Attractive compensation package, professional growth opportunities, and a dynamic work environment.
">