Execute quality assurance review activities for local and global change control elements. Revise and create standard operating procedures, work instructions, and other controlled documents, utilizing Agile electronic quality management system for their processing. Assist with quality feedback investigations, nonconformance reports, packaging verifications, and validations.
- Provide guidance on requirements from a quality assurance perspective for packaging and new product launch change orders to ensure compliance in support of global packaging and supply chain.
- Analyze document change orders and deviations for all controlled documents.
- Manage training positions and roles in Agile for local and global departments.
- Provide quality assurance oversight to supplier nonconformance’s generated by customer service.
- Assist management with review and approval of corrective and preventative action, nonconformance reports, and quality feedback.
- Assist with process audits to verify conformance with standard operating procedures (SOPs), which includes editing and / or creating SOPs.
- Generate or contribute to monthly quality reports for leadership, ensuring timely completion.
- Perform data-entry and analysis in Agile and MS Access and Excel.
- Properly archive quality records and assists in their retention and retrieval.
- Perform or facility annual quality systems regulation retraining as required.
- 3 years’ experience with document control (e.g. nonconformance, quality feedback, standard operating procedures).
- Medical device or other regulatory industry experience.
- Working knowledge of MS Office Suite and Agile.
- Knowledge of quality assurance regulations and methodologies, including good documentation practices.
- Ability to utilize continuous improvement and change management concepts within a team.