What are the responsibilities and job description for the Quality Audit Program Manager, Quality & Regulatory Compliance - Remote position at Talentify.io?
Employer Industry: Medical Technology
Why Consider This Job Opportunity
"We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer."
Talentify helps candidates around the world to discover and stay focused on the jobs they want until they can complete a full application in the hiring company career page/ATS.
Why Consider This Job Opportunity
- Salary up to $208,900.00 USD annually
- Opportunity for career advancement and growth within the organization
- Supportive and collaborative work environment
- Chance to make a positive impact in the healthcare industry
- Comprehensive benefits package including rewards and recognition programs
- Commitment to professional development and continuous learning
- Manage and conduct quality system audits to ensure compliance with regulations and standards
- Establish and lead audit teams with qualified auditors
- Evaluate audit evidence against the approved Audit Action Plan (AAP)
- Maintain the audit system software database and provide periodic reports to management
- Collaborate with various levels of management and compliance personnel to address non-conformances
- B.S. in Engineering, Chemistry, Biology, or equivalent discipline; advanced degree preferred
- Minimum 10 years of experience in the Quality organization of a medical device or pharmaceutical company
- At least 5 years of auditing experience with compliance to domestic and international regulations
- Required certifications: Certified Quality Auditor/ISO Lead Auditor Certified, Certified Quality Engineer, or Certified Manager of Quality/Organizational Excellence
- Strong knowledge of medical device regulations and auditing principles
- Exemplar Global ISO 13485 Lead Auditor Certification or equivalent
- Experience with regulatory actions such as warning letters
- Advanced knowledge of international medical device regulations
- Demonstrated ability to collaborate effectively across all management levels
- Strong analytical and project management skills
"We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer."
Talentify helps candidates around the world to discover and stay focused on the jobs they want until they can complete a full application in the hiring company career page/ATS.
Salary : $126,600 - $208,900
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