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Quality Systems Compliance Manager

3 months ago

Whitestown, United States Aegis Worldwide Full time

Aegis Worldwide


Quality Systems Compliance Manager


Whitestown, IN


$43-$48 an hour


If you are looking for a great company with an awesome company culture, consider this contract Quality Systems Compliance Manager role in the Whitestown, IN area Aegis Worldwide is partnered with a manufacturer in Whitestown, IN and we are looking for candidates that have 3-5 years of quality compliance experience, QMS, experience within medical device or pharmaceutical industries, familiar with 21CFS 8200, ISO13485, and CAPA

Apply Now


Responsibilities:

  • Ensure compliance of quality system to 21CFR820, the European IVDD directive, and ISO 13485, as well as various other standards and regulations.
  • Developing policies and strategies: Creating compliance policies and strategies
  • Conducting audits: Performing internal audits to assess compliance with requirements and identify potential issues
  • Training employees: Informing employees of their role in compliance and training them on compliance protocols
  • Maintaining records: Ensuring proper record-keeping and documentation of compliance practices
  • Investigating incidents: Looking into potential violations and incidents
  • Advising management: Providing guidance to management on compliance matters
  • Liaising with external bodies: Keeping up to date with regulatory changes and industry requirements
  • Visiting sites: Ensuring that agreed procedures are being implemented


Qualifications:

  • Extensive knowledge and deep familiarity with ISO 13485, 21 CFR Part 820 and IVD Directive.
  • Training as a Quality Systems auditor preferred
  • Understanding of formal problem-solving techniques.
  • Experience managing professional staff.
  • Ability to effectively communicate quality system requirements to diverse groups at all levels of the organization.