Quality Assurance Leadership Role
This position presents a unique opportunity for an experienced quality assurance professional to take on a senior leadership role in medical device design.
Job Description:
Senior Design Assurance Engineers will lead quality-related activities, including device testing and validations, internal and external audits, and generation of technical documents.
Key Responsibilities:
* Lead quality-related activities including device testing and associated validations
* Internal and external audits, serving as SME for design processes
* Generation and/or approval of technical documents on behalf of the Quality function
* Management of Design History Files (DHF)
* Continuous improvement of the Quality Management System (QMS)
Requirements:
* 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.
* At least 4 years in QA activities related to product design and development.
Preferred Skills:
* Project management and leadership experience.
* In-depth knowledge of FDA 21 CFR Part 820 (QMSR), ISO 13485:2016, EU MDR, Canadian Medical Device Regulations, and other international standards.
* Proven track record in preparing for and participating in notified body and FDA inspections.
About the Role:
* This is a senior-level opportunity to lead quality and compliance activities in medical device design.
* Directly influence the safety, reliability, and market success of life-changing technologies.
Benefits:
* Results-driven with the ability to manage multiple priorities in a fast-paced environment.
* Excellent interpersonal skills with the ability to influence and collaborate effectively across teams.
* Strong written and verbal communication skills, with fluency in English.