The QA Engineer is responsible for all activities involving quality assurance and compliance with applicable regulatory requirements. The position manages quality assurance programs and processes to ensure the quality of product conforms to the established procedures and applicable regulatory requirements.
Requirements
- Provide QA Engineering input and guidance during manufacturing, production and design activities in support of new product introductions and modifications to existing products.
- Conduct Internal Audits to ensure compliance with the established procedures and applicable regulatory requirements.
- Maintain and continuously improve the inspection readiness program to ensure the site is always prepared for regulatory and internal audits.
- Manage processing of Complaints and CAPAs.
- Monitor and ensure compliance with applicable regulatory standards applicable to Mizuho OSI (QMSR, ISO 13485, ISO 14971, EU MDR, REACH, RoHS, PFAS, etc.).
- Participate in the development and implementation of quality policies, procedures, and processes aligning with GMPs and applicable regulations.
- Work closely with multi-functional teams / system owners to lead and/or support continuous improvement initiatives related to QMS improvement.
- Develop quality data management tools, applicable compliance performance metrics (KPIs) and remediation plans for identified non-conformances.
- In collaboration with RA, Marketing and Manufacturing teams, manage all aspects of labeling process for registered company products, ensuring accuracy, compliance, and consistency of labeling content throughout product lifecycle.
- Maintain internal procedures for labeling design, processing, and control to ensure compliance with applicable requirements by regularly reviewing and updating the procedures as necessary.
- Review and develop documentation for acceptance, monitoring and validations for EO/Gamma/E-Beam sterilization and clean/controlled manufacturing environment.
- Utilize standard statistical analysis techniques to determine product acceptance: evaluate process capabilities; and develop statistically sound tolerance limits based on product specifications, recommend sampling plans, inspection methods, etc.
- Responsible for a professional work area to include cleanliness, organization, and overall QA department appearance.
- To be willing to share knowledge and instruct other members of the department and the company, by passing along skills and information to assist them in their development.
- To help create an ongoing effort through personal action and by contributing ideas to support both the department and Company’s ongoing improvement efforts.
- To understand Mizuho OSI’s business objectives and the relationship between the department and those objectives.
- To understand, follow and support Mizuho OSI’s internal Quality System policies, procedures and work instructions including but not limited to applicable external regulations (FDA’s QMSR, ISO 13485, ISO 14971 and applicable International Standards).
Benefits
- Comprehensive benefits package
- Annual potential bonus
