Job Title: Quality Control Specialist
Job Description
Key Responsibilities:
* Maintain the effectiveness of our quality management system and continually improve it.
* Manage daily QA activities, including frequent communication with suppliers, consultants, and contractors, as well as handling multiple projects related to product enhancements and compliance.
* Assist in notified body audits and internal audits.
* Coordinate quality system schedules, including supplier and internal audits management review and documentation updates.
* Support the team to ensure product manufacture and testing meets requirements.
* Develop and maintain strong relationships with suppliers, monitor their performance, and conduct audits to ensure compliance with quality standards.
* Investigate, analyze, and resolve product quality issues, including root cause analysis and implementing corrective and preventive actions.
* Ensure incoming materials meet required specifications and collaborate with the engineering team to address quality concerns.
* Oversee Post Market Surveillance activities, including coordinating investigations between complainants and contract manufacturing sites, following up on corrective actions when required. Support Significant Changes and Notified Body interactions.
* Perform other quality-related duties as required, including updating procedures, forms, processes, and periodic reviews.
Required Skills and Qualifications
* Bachelor's degree in engineering or science.
* Quality certification in ISO 13485 is mandatory.
* A minimum of four years of experience in a medical device QA position 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.