Apply

Manager of Quality Compliance - REMOTE

Posted 3 days agoViewed

View full description

💎 Seniority level: Manager, Minimum of 7 years

📍 Location: US

💸 Salary: 100000.0 - 165000.0 USD per year

🔍 Industry: Medical Devices

🏢 Company: RefleXion Medical👥 101-250💰 $105,000,000 about 1 year agoBiotechnologyTherapeuticsMedicalMedical DeviceHealth Care

🗣️ Languages: English

⏳ Experience: Minimum of 7 years

Requirements:
  • Bachelor's of Science (BS) in Engineering, Sciences, or a similar field.
  • Minimum of 7 years of experience in the medical device industry.
  • Advanced knowledge of Class II Medical Device Complaint files and regulatory requirements.
  • Experience with Quality Management System and regulatory reporting (21 CFR, EU/MDR).
  • Strong computer skills, especially in Microsoft Office Suite and digital complaint handling systems.
  • Leadership and interpersonal skills to foster collaboration with various internal departments.
Responsibilities:
  • Responsible for processing complaints and facilitating investigations to ensure proper documentation and timely resolution.
  • Lead the Complaint Assessment Board to review and prioritize complaints.
  • Maintain the complaint handling system and ensure timely MDR reporting.
  • Establish Quality Data Metrics for complaints and other QMS processes.
  • Support third-party audits and inspections as a subject matter expert.
  • Process QNCRs and CAPAs to ensure proper documentation and timely closure.
  • Draft and update QMS documentation and contribute to QMS training.
Apply

Related Articles

Posted 4 months ago

Insights into the evolving landscape of remote work in 2024 reveal the importance of certifications and continuous learning. This article breaks down emerging trends, sought-after certifications, and provides practical solutions for enhancing your employability and expertise. What skills will be essential for remote job seekers, and how can you navigate this dynamic market to secure your dream role?

Posted 4 months ago

Explore the challenges and strategies of maintaining work-life balance while working remotely. Learn about unique aspects of remote work, associated challenges, historical context, and effective strategies to separate work and personal life.

Posted 4 months ago

Google is gearing up to expand its remote job listings, promising more opportunities across various departments and regions. Find out how this move can benefit job seekers and impact the market.

Posted 4 months ago

Learn about the importance of pre-onboarding preparation for remote employees, including checklist creation, documentation, tools and equipment setup, communication plans, and feedback strategies. Discover how proactive pre-onboarding can enhance job performance, increase retention rates, and foster a sense of belonging from day one.

Posted 4 months ago

The article explores the current statistics for remote work in 2024, covering the percentage of the global workforce working remotely, growth trends, popular industries and job roles, geographic distribution of remote workers, demographic trends, work models comparison, job satisfaction, and productivity insights.