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Title:  Senior Manager, Quality Control

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: VP, Quality and Regulatory

 

PURPOSE OF POSITION:

Manages activities of team including supervisors and/or individual contributors in the Quality Assurance Department with Manufacturing Operations and New Product Development activities.

QUALIFICATIONS

 

 

Required:

  • A minimum of 5 years of device design and development or Quality Management System experience.
  • Bachelor's degree or master’s degree from an accredited university.
  • A minimum of 6 years of relevant experience; OR master’s degree in related field plus 4 years’ experience in a related industry.
  • Minimum of 3 years of experience in Managing employees or teams in Medical Device
  • Travel Requirements ~15%

Preferred:

 

  • Six Sigma or Project Management Professional certification is a plus
  • Prefer SAP experience

 

Skills & Competencies:

  • Ability to lead quality control group by providing daily direction, resource planning, and develop longer term strategies
  • Establish departmental metrics and goals in support of organizational strategic goals.
  • Experience with Quality Control/Assurance procedures and possess a detailed knowledge of product components and their impact on assembly and use of the finished product.
  • Strong knowledge of medical device manufacturing systems and methods.
  • Competent with word processing, spreadsheets, and statistical analysis software packages (preferably Word, Excel, and Minitab).
  • Strong ability to collaborate with Manufacturing and Engineering teams

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:

  • Manage laboratories
  • Compile and review laboratory analytical data
  • Generate Certificates of Analysis (COA) for lot release
  • Author or update QC SOPs, protocols, and specification records supporting testing activities
  • Review and trend data and support data inputs to Quality Program Reviews (e.g. PQR, QMR, AR, APQR)
  • Lead and support lab investigations, deviations, CAPA implementation, and change control activities in support of QC operations
  • Evaluate and continuously improve QC systems and procedures to ensure compliance with current regulations
  • Interface with the analytical team, QA, Operations and Regulatory to execute Enable Injections' operational plan
  • Monitor lab performance via key metrics and partner with internal and external stakeholders to improve performance
  • Assure qualification and validation status of lot release and stability indicating methods
  • Author and/or review relevant sections in regulatory submissions
  • Support specification development and revision as required
  • Support contract organization and vendor audits as required
  • Own POs and monitor external expenses supporting routine testing operations

 

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