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Title:  Senior Specialist, Quality

Requisition Number: 
Description: 

 

Enable Injections is made up of a team passionate about working together to make people’s lives better. We develop, manufacture, and support the enFuse®, a platform of wearable infusion devices designed to enable subcutaneous self-administration of high-volume therapeutics. Enable employees are technology experts focused on an exceptional patient experience in collaboration with our biopharma partners.

 

SUPERVISOR’S TITLE:  Senior Manager, QA

 

 

PURPOSE OF POSITION:  With minimal to no direction of the Senior Quality Assurance Manager, the Sr. Quality Assurance Specialist will be responsible for the execution of the Quality System programs.  Perform audits of production areas and assist in completion of end of line QA inspection processes.  Manages Internal Audits and Supplier Audits, and other Quality System related activities such as: CAPA, NCR, NCMR, and Product Complaint investigations.  Performs tracking and trending of key metrics for the Quality Systems.   This position will also support external audits and other Quality related activities as required.

 

QUALIFICATIONS

 

 

Required: 

  • Bachelor’s Degree or equivalent combination of education, training, and experience. 
  • 5+ years of experience in Quality Assurance for the pharmaceutical or medical device industries.

 

Preferred:

  • ISO 13485:2016 Auditor Certification
  • Strong Audit report writing skills
  • Strong communication skills – verbal and written
  • Strong problem-solving skills and ability to work independently
  • Strong interpersonal skills
  • Solid understanding of product complaint requirements
  • Solid understanding of Quality System requirements (i.e. CAPA, Nonconformances, etc.) in a regulated medical device and/or pharmaceutical environment
  • Strong understanding of device and/or pharmaceutical regulatory and compliance requirements

Skills & Competencies:

  • Strong computer skills including Microsoft Office and databases/excel spreadsheets
  • Knowledge of e-mail/scheduling software application
  • Ability to learn and utilize future software/applications as it is deployed

Physical Requirements: 

  • Must be able to remain in a stationary position for extended periods of time
  • Ability to lift and lower boxes of documents or handle equipment weighing up to 25 lbs.
  • Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc. 

 

 

 

RESPONSIBILITIES:

  • Responsible for providing Quality oversight for the established Quality systems
  • Corrective and Preventive (CAPA) Quality System
  • Nonconformances and Nonconforming Materials
  • Approved Supplier List; Supplier Audits, and SCARs
  • Internal Audit program
  • Product complaints
  • Training
  • Quality System Change Orders
  • SAP ERP System Maintenance and Oversite
  • Assists Quality Management in providing guidance on compliance related issues
  • Ensures product safety, regulatory compliance, and compliance through proper management of quality documents and quality records
  • Develops or updates quality procedures and work instructions, when required
  • Performs internal audits as required to meet the internal audit schedule
  • Identifies areas of opportunity to reduce waste and improve efficiency
  • Files and maintains records in accordance with established policies, procedures and regulatory requirements
  • Responsible for updating of Quality Controlled Logs specific to assigned tasks
  • Assist with Management Review metrics and documentation
  • Provides assistance during Regulatory and customer audits
  • Develops and manages Quality Agreements with Critical Suppliers
  • Performs Batch Disposition responsibilities for Materials, Components, and Sub-Assemblies
  • Assists with the assembly and execution of Management Reviews
  • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job.  Duties, responsibilities and activities may change at any time with or without notice.
   

 

 

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.  


Nearest Major Market: Cincinnati