Internal Auditor for PromptCare Companies responsible for managing documents and audits. Ensuring compliance and communication with team, enhancing documentation processes.
About the role
- Quality Auditor ensuring compliance with industry regulations at Solventum, a healthcare company. Assessing suppliers and maintaining quality standards for better healthcare products.
Responsibilities
- Conduct Supplier Audits: Evaluate quality management systems, processes, and documentation to ensure regulatory compliance, and track non-conformances and corrective actions.
- Supplier Qualification and Assessment: Assess new suppliers for suitability and regularly reassess existing suppliers to ensure ongoing compliance and consistent performance.
- Issue Resolution & Continuous Improvement: Collaborate closely with suppliers to implement and verify the effectiveness of CAPAs and drive continuous improvement initiatives.
- Documentation & Reporting: Maintain complete audit documentation and prepare audit results and performance metrics for senior management.
- Cross-functional Collaboration & Communication: Work closely with internal stakeholders and support suppliers in meeting quality and regulatory requirements.
Requirements
- Bachelor’s degree from an accredited college or university or equivalent industry experience
- Fundamental experience in a quality-related auditing role in a regulated industry
- Certified Lead Auditor from an accredited agency (AAMI, ASQ, ISO, etc.), ISO 13485 preferred
- In-depth knowledge of industry standards and regulations (Ex: ISO 13485, ISO 9001, ISO 17025, ISO 22716, FDA, CFR, EU MDR)
- Strong analytical, root-cause analysis, and problem-solving skills
- Excellent English written and verbal communication skills
- Ability to work independently and manage multiple projects simultaneously
- Proficiency in Microsoft Office Suite and quality management software
- Keen attention to detail, with the ability to identify small issues that could escalate into larger problems if left unaddressed
- Must demonstrate a high level of integrity, professionalism, and adherence to ethical standards in their conduct
- Critical thinking skills are essential, enabling the candidate to make sound judgments
- Strong team player, capable of working effectively with others, and possess the adaptability to handle changing priorities and work environments
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development programs
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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