Regulatory Compliance Manager
3 days ago
StarrTrax is looking for a skilled Quality Engineer to lead our quality initiatives. As a key member of our team, you will have the opportunity to develop and implement quality projects that drive business growth and improve customer satisfaction.
About the JobThis role requires a strong background in quality engineering, with a focus on continuous improvement and regulatory compliance. You will work closely with cross-functional teams to plan, coordinate, and implement quality projects that meet company objectives.
The estimated salary for this position is $125,000 per year, depending on experience and location.
Key Responsibilities- Process Improvement: Lead process mapping and continuous improvement activities using Lean principles and tools.
- Risk Assessment: Perform site-based risk assessments to identify potential hazards and develop mitigation strategies.
- Quality Control: Support quality control plan analysis and improvements, including packaging development and execution of related projects and action items.
- Data Analysis: Coordinate, collect, and analyze data for customers; troubleshoot and resolve customer issues; provide root cause analysis and corrective/preventative actions to eliminate reoccurrences.
- CAPA Management: Manage assigned CAPA(s) by performing root cause investigations, while defining resolution actions; implement preventative and corrective actions in a timely manner resulting from customer complaints, internal or customer audit findings.
- Trend Analysis: Complete trend analysis for quality data (i.e., non-conformances, complaints, etc.).
- Audit Support: Prepare customer audit finding responses, as needed; serve as internal and/or supplier auditor.
- Training and Development: Develop and document best practice methods; ensure standardized procedures; train employees per established procedures, where applicable, and model cGMP.
- Compliance: Assure compliance with ISO certifications (ISO 9001, ISO 15378) and cGMP, along with adherence to Company policies and procedures and Code of Conduct/safety guidelines.
- Other Duties: Perform other duties as assigned.
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