We are seeking an experienced Medical Device Quality Assurance Specialist to join our team. This individual will be responsible for ensuring the quality of our medical devices from early development phases through to commercialization.
The ideal candidate will have a proven track record in quality and regulatory control of medical devices, with experience in leading compliance and improvement activities associated with the quality system. They will also possess strong problem-solving skills, excellent interpersonal and written communication skills, and the ability to work effectively as part of a team.
Responsibilities:
* Responsible for compliance with policies and procedures, national and international regulations, and industry standards
* Leads compliance and improvement activities associated with the quality system, including CAPA, audit programs, personnel training, and corrective actions
* Apply thorough, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
* Plan, execute, report, and follow-up on quality system audits, act as an audit escort, and support in the coordination of backroom activity during inspections
* Provide expertise in quality assurance, controls, and systems to support and develop the QMS
* Develop and implement control plans, inspection plans, and testing strategies to ensure product compliance with design and regulatory requirements
* Work closely with suppliers to ensure robust quality agreements are in place, including periodic review of their quality metrics
* Provide ongoing support to internal teams in the development of products, through first article inspection qualifications, test method development, and approval activities
* Gather and analyze data to support statistical rational sample testing requirements during early product development and ensure compliance with product specifications, regulations, and internal requirements
* Prepare and maintain detailed records of inspections, testing, and non-conformance reports
* Collect, analyze, and report key data related to product testing, supplier performance, and internal quality metrics
* Use data-driven insights to drive continuous improvement initiatives, ensuring optimal product quality and process efficiency
* Develop test protocols or reports to support design validations and verification activities
* Support quality control activities relating to lot release of finished devices, received products, or other QC activities
* Review and approve changes to product, processes, and existing medical device products conducted in compliance with global regulations and internal procedures
Requirements:
1. Degree in quality engineering, life science, or related field
2. 3-5 years' experience at a quality assurance role in the medical device sector, preferably in a FDA/MDR regulated environment
3. Quality certification and lead auditor certification an advantage
4. Knowledge of FDA's 21 CFR Part 820 (Quality System Regulation) and ISO 13485:2016
5. In-depth knowledge of quality engineering principles, methodologies, and tools
6. Experience in QA activities associated with the design and development of medical devices
7. Results and deadline-driven with an ability to handle multiple tasks and operate in a fast-paced environment
8. Excellent interpersonal skills and ability to work with people to achieve results
9. Excellent written and communication skills, fluency in English, attention to detail, and strong technical writing skills
10. Proven record of policy and procedure development
11. Good judgment and decision-making, problem-solving ability
12. Highly motivated with excellent communication skills and proven ability to work effectively as part of a team and interact professionally with all organizational levels
13. Proficiency in MS Office products
14. Good business acumen and enthusiastic self-starter