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Quality Assurance Compliance Leader
2 months ago
Aegis Worldwide
Position: Quality Systems Compliance Manager
Location: Whitestown, IN
Compensation: $43-$48 per hour
Shift: 1st Shift
Contract Duration: 12 months
If you are seeking a rewarding opportunity with a company that values its employees, consider the role of Quality Systems Compliance Manager at Aegis Worldwide. We are collaborating with a prominent manufacturer in the Whitestown area and are in search of candidates who possess 3-5 years of experience in quality compliance, knowledge of Quality Management Systems (QMS), and a background in the medical device or pharmaceutical sectors. Familiarity with 21 CFR 820, ISO 13485, and CAPA is essential.
Key Responsibilities:
- Ensure adherence to quality system regulations including 21 CFR 820, the European IVDD directive, and ISO 13485, along with other relevant standards.
- Formulate compliance policies and strategies to guide organizational practices.
- Conduct internal audits to evaluate compliance with established requirements and identify areas for improvement.
- Educate and train employees on their compliance responsibilities and protocols.
- Maintain accurate records and documentation of compliance activities.
- Investigate any incidents or potential compliance violations.
- Advise management on compliance-related issues and best practices.
- Engage with external regulatory bodies to stay informed on industry standards and changes.
- Perform site visits to verify the implementation of agreed-upon procedures.
Qualifications:
- Comprehensive knowledge of ISO 13485, 21 CFR Part 820, and the IVD Directive.
- Preferred training as a Quality Systems auditor.
- Familiarity with formal problem-solving methodologies.
- Experience in managing professional teams.
- Strong communication skills to convey quality system requirements across various organizational levels.
Aegis Worldwide offers a valuable opportunity for individuals looking to grow within a supportive and investment-focused environment.
