Cytrellis Biosystems, Inc. · 1 month ago
Manager, Quality Operations
Woburn,MA,US
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expCytrellis Biosystems, Inc. is a medical device company seeking a Sr. Manager, Quality Operations. This role is responsible for coordinating and maintaining Quality System processes and supporting commercialization and efficiency through strategic recommendations related to Quality Operations.
BiotechnologyHealth CareMedical
Responsibilities
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
Qualification
Required
Bachelor's degree in a scientific or technical field or equivalent experience
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
Preferred
Preferred Quality Operations/Production Controls experience, 10+ years
Company
Cytrellis Biosystems, Inc.
Cytrellis is a medical technology company dedicated to the development and commercialization of first-in-class aesthetic devices which emphasize safety, efficacy, and improved quality of life for our patients.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$86.09MKey Investors
D1 Capital PartnersMerz Venture InitiativeARCH Venture Partners
2021-01-04Series C· $50M
2018-06-05Series B· $28.5M
2015-02-20Series A· $7.14M
Leadership Team
Jason Richey
President & Chief Executive Officer
Shivkumar (Shiv) Sabesan
Chief Technology Officer
Recent News
Cytrellis Biosystems
2025-06-02
2025-06-02
Google Patent
2025-05-04
Company data provided by crunchbase