Enable Injections, Inc. · 2 weeks ago
Senior Specialist, Quality Control
Cincinnati Metro
Full-time
Onsite
Senior Level
6+ years expEnable Injections, Inc. is seeking a Senior Specialist in Quality Control to oversee equipment validation and quality assurance processes. The role involves managing gamma sterilization programs and ensuring compliance with quality standards in a laboratory setting.
Health CareLife ScienceManufacturingMedical Device
Responsibilities
Complete equipment validation (IOQ, PQ), ISO 8 clean room qualification and temperature mapping for quality laboratory equipment
Owns gamma sterilization program including conducting sterilization validations, coordinating quarterly dose audits and general maintenance for addition of new product models to the sterilization cycle
Quality oversight of equipment validation for cross functional departments, new equipment management and equipment maintenance programs
General laboratory activities including but not limited to, sample receipt, inventory control, testing, equipment and instrument operation/maintenance
Performs everyday laboratory requirements which includes cleaning, maintenance, ordering of supplies, and maintains adequate inventory of supplies needed for all microbiological testing
Schedules and tracks Calibration and Metrology activities
Qualification
Required
BS/BA in a Science or related field, or equivalent combination of education, training, and experience
6 years of experience in Quality Assurance for the pharmaceutical or medical device industries
Excellent communication skills
Knowledgeable in implementing and managing Quality Assurance systems and procedures
SME for at least one quality system where the individual is recognized outside the department as the point person
Familiar with medical device manufacturing systems and methods
Possess a strong balance of technical experience, analytical thinking, and communication skills for resolving issues internal and external to the organization
Competent with word processing, spreadsheets, and statistical analysis software packages (preferably Word, Excel, and Minitab)
Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), and ERP systems such as SAP
Ability to independently adapt behaviors and strategies to deal with emergent, non-routine and dynamic components of the job
Quickly adapts to a diverse array of changing needs, conditions, priorities, or opportunities
Solid ability to understand complexity and navigate ambiguity to influence at the department level
Plan and carry out multiple projects concurrently
Ability to analyze problems and troubleshoot solutions
Apply strong cognitive ability to collecting, processing, and disseminating information
Understand current state and dynamics of the business
Ability to foster teamwork, collaboration, negotiation, and influencing others
Consistently open and approachable
Engage colleagues and partners with the Enable Values in mind
Ability to maintain a positive attitude and show empathy for others
Ability to understand your own emotions and their effects on your performance
Ability to express your emotions appropriately and have a positive impact on others in support of company goals and a healthy work environment
Excellent time management skills
Must be able to remain in a stationary position for extended periods of time
Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc
Position requires being physically present on the premises during regular company hours or as approved by management
Company
Enable Injections, Inc.
Cincinnati-based Enable Injections is a global healthcare innovation company developing and manufacturing drug delivery systems designed to improve the patient experience.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$352MKey Investors
SanofiMagnetar CapitalORI Capital
2026-01-06Corporate Round· $30M
2022-01-27Series C· $215M
2020-09-08Debt Financing· $25M
Leadership Team
Mike Hooven
President and CEO
Tim Flaherty
Executive Vice President , Chief Financial Officer
Recent News
vcnewsdaily.com
2026-01-07
2026-01-07
Company data provided by crunchbase