Quality Assurance Manager

ABOUT US:

At Glacial Skin by R2 Technologies, Inc. we don't just lead the global CryoAesthetics space, we invented it!

Developed in collaboration with Massachusetts General Hospital and Blossom Innovations, our patented Cryomodulation technology powers advanced cold based treatments that reduce inflammation, brighten dark spots, and improve overall skin health.

Since launching in 2014, we’ve been growing fast - backed by strong partnerships, proven science, and a team that’s passionate about making impact. We continue to push the boundaries of aesthetics with our dynamic, ever-evolving product pipeline.

Learn more here: Glacial Skin | Precision Cooling Cryotherapy for Your Face & More

ABOUT YOU:

Responsible for providing on-site quality assurance management for quality system requirements associated with medical devices. Specific areas of support may include, product complaints, quality data tracking, trending, and analysis, quality events/product shortage execution, supplier controls, product quality review, risk management, agency inspections/internal audits, CAPA, NCMRs, and overall quality manual requirements. This position will ensure that all product, process, and system related quality activities supporting the business are in compliance with corporate, governmental, and local regulations and requirements.

WHAT YOU'LL DO:

• Responsible for leading, development, and management of effective and compliant quality systems and working closely with various cross functional members to ensure all requirements are described and meet the needs of regulations and functional excellence.
• Assist with the integration and support of quality system regulations.
• Evaluate, analyze, and trend quality indicators, data, and performance metrics; communication and elevation of compliance status and risk while maintaining a continuous improvement objective.
• Partner, coordinate, and support activities related to production, including product inspections and facility inspections.
• Quality management of supplier qualification program including performance monitoring for key suppliers.
• Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans.
• Assist project teams in planning, preparation, review, and approval of quality documentation.
• Coordinate the Quality Management Review process.
• Coordinate and investigate quality events such as deviations, non-conformances, product complaints and corresponding action plans including decisions.
• Ensure metrics and KPIs are being met.
• Represent QA in regional, global, and cross functional teams, projects, and programs, as assigned by management.
  
  

WHAT YOU'LL BRING:

• Bachelor’s degree in engineering or Life/Health Sciences
• Six (6) years of experience in Quality Assurance
• Proficient in all MS Office applications
• Knowledge of national and international regulations applicable to medical devices including; Quality System Regulations, 21 CFR 820, 21 CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, EU MDR, ISO 14971, and ISO 13485etc.
• Prior experience in medical device manufacturing environment
• Ability to identify the strategic direction of the quality assurance system
• Ability to analyze and interpret all regulatory and quality guidelines as needed
• Certification(s) – ASQ Certified Quality Manager; Certified Quality Engineer, or Certified Quality Auditor preferred
  
  

WHAT YOU'LL GET:

• Competitive salary packages
• Company-paid medical, dental, and vision insurance - $0 deductible PPO is our base plan!
• 401(k) with company match
• And more to explore!