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Quality Systems Compliance Manager
4 weeks ago
Aegis Worldwide
Quality Systems Compliance Manager
Whitestown, IN
$43-$48 an hour
1st Shift
Contract (12 months)
If you are looking for a great company with an awesome company culture, consider this 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.
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