Job Title: Quality Assurance Associate
Description:
* This role involves assisting in the maintenance of the quality management system, managing internal processes and external vendors to ensure product quality.
* The successful candidate will have a working knowledge of medical device regulatory requirements and standard practices in the medical device industry.
Main Responsibilities:
* Maintain the effectiveness of the quality management system and make continuous improvements to it.
* Manage day-to-day quality assurance activities including frequent interface with contract manufacturers, quality assurance consultants, and testing contractors as well as handle multiple projects related to product and compliance enhancements.
* Assist in notified body audits and internal audits.
* Maintain and coordinate quality system schedules, including: Supplier and internal audits; management review and documentation updates.
* Support the wider team to ensure product manufacture and testing meets the requirements.
* Build and maintain strong relationships with suppliers, monitor their performance, and conduct audits to ensure compliance with quality standards.
* Investigate, analyse, and resolve any product quality problems, including root cause analysis and implementing corrective and preventive actions.
* Ensure that incoming materials meet the required specifications and work with the engineering team to address any quality concerns.
* Maintain the day-to-day activities of post market surveillance, including coordinating investigations between complainants and contract manufacturing sites, follow up on corrective actions when required, and support with significant changes and notified body interactions.
* Carry out other quality-related duties as required, inclusive of updates to procedures, forms, processes, and periodic reviews.
Required Skills and Qualifications:
* 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 quality assurance position(s) role within a medical device organisation.
* 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.
About Us:
We are a leading life-science recruitment company dedicated to providing top talent to our clients across the pharmaceutical, biotechnology, and medical device industries.