Quality Assurance Associate
This role involves maintaining our Quality Management System and managing internal processes and external vendors to ensure product quality.
Key Responsibilities:
* Maintaining the effectiveness of the QMS and making continuous improvements to it.
* Managing day-to-day QA activities, including frequent interface with contract manufacturers, QA consultants, and testing contractors.
* Assisting in notified body audits and internal audits.
* Maintaining and coordinating quality system schedules, including supplier and internal audits, management review, and documentation updates.
* Supporting the wider team to ensure product manufacture and testing meets requirements.
* Building and maintaining strong relationships with suppliers, monitoring their performance, and conducting audits to ensure compliance with quality standards.
* Investigating, analyzing, and resolving product quality problems, including root cause analysis and implementing corrective and preventive actions.
* Ensuring incoming materials meet required specifications and working with the engineering team to address any quality concerns.
Requirements:
* Bachelor's degree in engineering or science. Quality certification in ISO 13485 is a must.
* A minimum of 4 years of experience in a medical device QA position(s) role within a medical device organization.
* Thorough understanding and knowledge of ISO 13485 and ISO 14971, EU MDR, and 21 CFR Part 820.
* Desirable to have lead auditor certification and/or regulatory certifications.
* Proven track record with the ability to successfully manage projects to deadlines.
* Good documentation practice experience.
* Report & technical writing experience.
* Project management experience.
* Strong ability to manage critical projects as part of an interdisciplinary team.
* Excellent problem-solving and communication skills.
This is an exciting opportunity for a motivated and detail-oriented individual to contribute to the development of innovative medical devices that simplify surgical procedures.