Senior Quality Specialist

3 weeks ago


San Diego, California, United States MILLENNIUMSOFT Full time
Job Title: Senior Quality Specialist

Job Summary:

We are seeking a highly skilled Senior Quality Specialist to join our team at MillenniumSoft. The ideal candidate will have a strong background in quality assurance, regulatory compliance, and complaint management.

Key Responsibilities:

* Collaborate with clinical, technical, and regulatory employees to determine product event status and MDR reportability
* Ensure timeliness and compliance with all FDA regulations and standards related to the review of events/complaints for BD products
* Write and submit eMDR reports to the FDA and Health Canada in strict adherence with regulatory requirements and timelines
* Coordinate, research, and prepare correspondence in response to FDA and global regulatory agencies requests for additional information
* Maintain complaint and MDR file documentation in accordance with regulatory requirements

Qualifications:

* Bachelor's degree in a relevant field (chemistry, engineering, nursing) strongly preferred
* 1 to 2 years' experience in Quality, Regulatory, or Complaint management is preferred
* Strong knowledge of QA, Regulatory/Quality Compliance in a medical device industry
* Excellent communication, organization, presentation, and writing skills

What We Offer:

* Opportunity to work with a leading medical device company
* Collaborative and dynamic work environment
* Professional development and growth opportunities

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