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Title:  Specialist II, Quality Assurance

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

Quality Assurance

 

 

PURPOSE OF POSITION:

With minimal to no direction of the Quality Assurance Manager, the 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 reporting 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 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

 

 

 

 

 

Physical Requirements:

 

  • 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

 

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
  • 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

 

 

 

 

 

 

 

 

 

 

 

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