This position is responsible for the development, implementation of policies and procedures focused on delivering product and services that are in compliance with company Quality systems and regulatory requirements. This position ensures the development, manufacturing, testing and release of products are performed according to the applicable GMP, ISO, and other relevant internal and international standards.
General Description and Duties:
To perform this job successfully, an individual must be able to perform each essential task satisfactorily. The tasks listed below are representative of the knowledge, skill, and/or ability required to perform this job effectively.
- Performs basic regulatory compliance analysis.
- Supports the product development team in various component and system testing.
- Specifies system components to ensure conformance with engineering design and performance specifications.
- Receives, inspects, tests and properly documents incoming components, assemblies, and finished goods.
- Implements and maintains company quality systems in compliance with FDA, International Standards (ISO), and other regulatory agencies.
- Supports regulatory agency communication on compliance issues including registration and licensing of facilities and regulatory agency audits and inspections.
- Collaborates with engineering and Quality to resolve non-conformances.
- Maintains proper material labeling and dispositioning in inventory.
- Properly maintains and completes operational records, reports, and other required documents.
- May be necessary to test and manage resulting documentation.
- May be necessary to support the implementation of quality inspection procedures, including sampling plans, for production level components and finished goods.
- May be necessary to contribute the development and implementation of inspection, programming, and the other manufacturing fixtures, measurement systems and calibration of such tools.
- Reviews and updates assigned controlled documents (e.g. work instructions, quality specifications, engineering specifications, procedures and validation protocols).
- Performs job functions in a safe and effective manner. Helps promote employee adherence to safe procedures and practices throughout the company.
- Maintains compliance of quality related logs and records, including but not limited to, inspection datasheets, lab notebooks, Receiving Log, CAPA, NCMR, ASL, CAL/PM, and Training.
Projects and Other Duties:
- Perform other duties as assigned by the Manager, Product Assurance.
- Knowledge of other engineering disciplines such as Biomedical, electrical, Software, etc.
- Excellent problem solving, critical thinking, and time management skills.
- Proficient in Microsoft Office Suite such as Word, Excel, and PowerPoint.
- Proficient in the English language: speaking, reading, and writing.
- Ability to set up test framework.
- Able to work independently or in a team setting.
- Understanding of good engineering practices in hardware, software and electronic design.
- Understanding of safety critical environment, problem solving, and debugging skills.
- Comprehensive understanding of black box / white box testing using commercial products.
- Familiarity in using software configuration management tools.
- Associate’s Degree in Biomedical Engineering, Mechanical Engineering, Software Engineering, Electrical Engineering, Electronics or equivalent experience.
- 2 years in a Quality/Product Assurance Technician role is preferred
- Experience in medical devices is preferred