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Third Rock Ventures - Redwood City, CA

posted 21 days ago

Full-time - Senior
Redwood City, CA
Securities, Commodity Contracts, and Other Financial Investments and Related Activities

About the position

We are seeking a passionate and experienced Senior Quality Systems Specialist to join our team in creating life-saving medical devices. In this role, you will play a critical part in maintaining and enhancing our Quality System by overseeing key functions such as document and ECO review, training activities, change control, internal audits, complaint analysis, and CAPA management. If you have a strong background and proven expertise in managing these Quality System elements and are committed to excellence, we'd love to connect with you!

Responsibilities

  • Performs at a senior level of Quality Assurance tasks to ensure quality system compliance with applicable regulatory requirements.
  • Leads in developing and improving Standard Operating Procedures and/or Work Instruction as part of the Quality System procedure.
  • Responsible for reviewing QMS documentation (e.g., CAPAs, NCRs, Complaints, and change orders) to ensure quality records documentation accuracy and completeness.
  • Drives Quality System activities, including process and procedure changes, and ensures that the performance and quality of services conform to established internal and external standards and guidelines.
  • Works directly with internal clients with assistance from management and/or more senior level investigators to ensure follow-up of quality issues.
  • Responsible for Post Market Surveillance activities and compliance.
  • Facilitate MDR Committee for reportable events and completes Health Hazard Evaluation (HHE) and Health Risk Assessment (HRAs) in a timely manner.
  • Lead meetings with appropriate departments for specific customer complaint issues, determination and resolution of root causes for complaints.
  • Provides expertise and guidance in interpreting policies, regulatory and governmental regulations, and internal regulations to assure compliance.
  • Provide training to other employees as necessary on the company's QM processes, as well as to provide expertise and guidance to other team members.
  • Assist or support internal or external audits and drive towards resolutions to ensure compliance with the QSR and ISO standards.
  • Participates in cross-functional meetings with internal and external parties as required.
  • Supports management review process through development and generation of quality system metrics and generate monthly data as needed. Assist the management in creating QMR presentation slides.
  • Other tasks as assigned by management.

Requirements

  • Bachelor's degree in a scientific or engineering discipline, mechanical, electrical or software engineering preferred.
  • 5+ years experience in the medical device industry with 4+ years in a commercial environment.
  • Previous experience with PMS & MDR Reporting via FDA portal.
  • Knowledge of FDA 21 CFR 820, 21 CFR 803, and ISO 13485.
  • Experience working in the medical device industry, preferably Class III.
  • Strong communication and organization skills required.
  • Accuracy, attention to detail, and thoroughness.
  • Proficiency required with Microsoft applications.
  • Multidisciplinary experience in QMS processes (e.g., CAPAs, NCRs, complaints).
  • Strong leadership abilities and ability to train or provide guidance to other team members.

Benefits

  • Stock Options
  • 90% employer-paid medical, dental, and vision insurance
  • Company-paid Basic Life Insurance
  • 401(k) retirement plan (Traditional and Roth)
  • Competitive Paid Time Off
  • Paid Holidays
  • FSA (Flexible Spending Accounts)
  • HSA (Health Savings Account)
  • Employee Assistance Program through PEO
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