Manager, Quality Systems

1 week ago

Cincinnati Metropolitan Area, United States Enable Injections, Inc. Full time

Title: Manager, Quality Systems

Description
Location:
Onsite

Status Type:
Full Time

Qualifications
Required:

  • Bachelor's Degree in Scientific discipline
  • Minimum of 7 years of GXP experience
  • Minimum of 5 years of experience in the medical device or pharmaceutical industries

Preferred

  • Certified Quality Auditor (CQA)
  • Six Sigma or Project Management Professional certification is a plus

Skills & Competencies

  • Ability to lead quality systems group by providing daily direction, resource planning, and develop longer term strategies
  • Establish departmental metrics and goals in support of organizational strategic goals
  • Prefer SAP experience
  • Strong knowledge of medical device manufacturing systems and methods
  • Strong ability to collaborate cross-functionally
  • Knowledgeable in implementing and managing Quality Assurance systems and procedures
  • Familiar with medical device manufacturing systems and methods
  • Possess a good 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)

Physical Requirements

  • Must be able to remain in a stationary position for extended periods of time
  • Must be able to gown to access the controlled areas
  • Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.

Responsibilities

  • Manage several Quality system processes: documentation system, archive, change control, internal audit, training, and audit support
  • Lead and support process improvement & efficiency projects, as necessary
  • Able to lead audit teams to support external customers, regulatory bodies, and notified body audits. Responsible for developing and submitting responses
  • Implementation and maintenance of requirements needed to conform to ISO 13485, CFR 820, and MDR
  • Review/approval for Quality procedures and records
  • Reporting routine Quality metrics to the Senior Management team

Nearest Major Market:
Cincinnati

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