Vacancy expired!
- 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.
- 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.
- 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.
Vacancy expired!