Quality Manager - Boston

Quality Manager

Cytrellis

Cytrellis is a Massachusetts-based medical technology company pioneering new approaches in aesthetic medicine. Their flagship product, ellacor, uses proprietary “Micro-Coring®” technology to remove micro-cores of skin tissue offering a first-of-its-kind, minimally invasive, in-office option to reduce sagging skin and treat moderate to severe wrinkles without surgery, thermal energy, or scarring. Most recently, Cytrellis released ellacor 2.0, improving procedure speed, consistency, and patient healing times, a move that reinforces their mission to expand access to safe, effective, and innovative skin-rejuvenation treatments.

This is a Quality Manager role in Boston, MA. You will be responsible for interacting with all cross-functional teams to coordinate, execute, and maintain Quality System processes according to approved procedures in our medical device company. The Manager, Quality Operations will support commercialization, efficiency, and growth by making recommendations to management and business leaders, especially related to Quality Operations, Purchasing Controls, Production/Process Controls, and Environmental Controls.

The position may be required to perform all, or a combination of the following essential responsibilities as determined by necessity. This role is located at the Company’s Woburn, MA office.

• Ensuring and providing direction regarding proper implementation and oversight of Quality Operations and quality of the content including training, documentation and records

• Leading the implementation of company long range strategic QMS transformation initiatives

• Proactive planning and implementation of Quality strategic initiatives

• Establishing and providing change purchasing controls, production/process control systems including Inspection, Measurement and Test Systems as well as Environmental Monitoring with authors, process owners, and third parties in defining and producing lean Quality System Operations

• Establishing and managing proper Quality Operational specifically with P&PC and Supplier Quality review process

• Establish and maintain supplier controls working cross functionally with Supply Chain Management,
  R&D, and Suppliers.

• Establish and or enhance Supplier Control systems (process, audit, evaluation, and so on) that meet
  business needs and requirements.

• Establish monitoring and responding to metrics on the efficiency of the Supplier Quality and P&PC
  systems and its ability to support the business.

• Lead internal and external audits/inspections.

• Ensuring compliant and effective QMS are maintained in scope.

• Ensuring requirements are effective in processes in scope.

• Ensuring and providing direction regarding proper use of company incoming inspection, warehouse,
  NCMR, production/refurbishment, ESD, and Environmental controls. Partner closely with Quality
  Engineering Management, Manufacturing Engineering Management, and Operations Management for lean systems and compliance.

• Oversee product release to ensure that product is safe and effective for distribution.

• Provide direct support to Quality functions.

• Other duties as assigned.

• Bachelor’s degree in a scientific or technical field or equivalent experience.

• Preferred Quality Operations/Production Controls experience, 10+ years.

• 10+ years of experience in the Med/Device Industry, preferred

• Strong working knowledge of GMPs and other FDA regulations.

• Experience validating application activities.

• Solid Analytical skills – demonstrated ability to trouble shoot complex process/system issues.

• Experience in CAPA including root cause analysis, documenting findings/actions and implementing
  actions.

• Proven analytical capabilities.

• Excellent communication, organizational, and project management skills

• Successful experience working with cross functional teams across multiple work locations (third parties)

• Work cooperatively in a team environment.

• Competitive base salary in the mid-$150s range

• Annual bonus opportunity

• Equity participation in a growing, venture-backed medical device company

• Comprehensive health coverage (medical, dental, vision)

• 401(k) with company match

• Generous PTO plus paid holidays

• Hybrid work flexibility (hands-on role with some WFH flexibility)

• Paid parental leave

• Growth opportunity influence systems, processes, and scale without heavy bureaucracy