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Regulatory Compliance Manager
1 week ago
The Quality Engineer will be responsible for ensuring that our quality management systems meet the highest standards. This includes developing, implementing, and maintaining quality policies, procedures, and processes. The successful candidate will also be responsible for conducting audits, identifying areas for improvement, and implementing corrective actions.
Key Responsibilities
- Develops, implements, and maintains quality policies, procedures, and processes.
- Conducts audits to ensure compliance with quality management systems.
- Identifies areas for improvement and implements corrective actions.
- Assists with monitoring and assessing quality system metrics to ensure maintained compliance.
- Acts as a lead auditor for division internal audit program.
- Assists with completing quality projects and uses root cause analysis to assist in the completion of CAPAs.
- Supports or leads continuous improvement initiatives for quality management system processes.
- Assists with regulatory activities.
Requirements
- Bachelor's Degree, 3+ years of work equivalent experience (work in a manufacturing environment is preferred).
- Master's Degree, 1+ years of work equivalent experience (work in a manufacturing environment is preferred).
- Proficiency in Microsoft office.
- ISO 13485 and 21 CFR 820 Quality Management Systems knowledge.
- Internal auditor experience and/or training.
- Must be detail oriented and accurate.
- Ability to apply basic mathematical concepts such as percentages, ratios, and proportions to practical situations.
- Ability to work across matrix organizations and external consultants.
- Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.
Why Work With Us
