This position is responsible for compliance and maintenance of the Quality System within the requirements of FDA's Quality System Regulation (QSR), ISO 13485:2003 (ISO), and other applicable standards. Specifically, position functions include support of product development, validation, process improvement, and qualification. Support of the audit program is within the scope of this position.
- Support validation activities for products, processes, equipment and facilities. This includes review and support of protocols, protocol execution, deviation /investigation resolution, test results, and protocol reports.
- Quality activities related to new product development with focus on design control, validation, risk management, and product life cycle compliance.
- Review and verification of development and process transfer documentation and records, including QC test results, analytical results and other records, as needed.
- Support the internal auditor program through participation, conducting internal audits.
- Facilitate and assist with initiatives for continuous improvement.
- Partner with company personnel to promote improvements through the use of data, analysis and training.
- Participate in other Quality System functions, such as product release, design control and document control, as required to support the achievement of departmental goals.
- Review records and documents, for completeness and compliance with QSR, ISO and Company requirements.
- Bachelor's Degree in scientific, quality system or a related discipline.
- Minimum of eight years quality assurance experience in a regulated (medical device/biotech) development and manufacturing environment.
- Excellent verbal and written communication skills in-group or one-on-one settings.
- Computer skills, e.g., Word, Excel, Power Point, Microsoft Project, electronic documentation systems, and ERP or electronic Quality Management systems.
- Ability to interface well with people of varied backgrounds, and to guide groups towards effective dynamics.
- Experience with internal auditing to QSR and ISO 13485 requirements.
- Experience with data management for a variety of data sets, and SPC techniques.
- Experience in defining metrics and analyzing data from processes using statistical analysis for improvement opportunities.
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