Biomat USA, Inc. Medical Device Specialist in Seattle, Washington
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout the evaluation, review and approval of validation and quality assurance/control documentation. Mainly focus on Medical Devices regulations including 510(k) processes.
Coordinate and assist in validation activities associated with medical devices used within Biomat USA
Assist in ensuring validation approaches are current to regulatory expectations and standards within the industry
Write and/or review Risk Analysis documents
Write test cases to validate critical control points, user requirements, and functional designs
Execute test cases, as needed
Analyze validation data to ensure acceptance criteria are met
Write and/or review Traceability Matrix
Prepare validation reports
Evaluate adequacy of corrective actions
Coordinate and assist in regulatory activities associated with medical devices used within Biomat USA
Contribute to 510(k) Premarket Notifications assessments for new and existing medical devices
Write and/or review regulatory documentation
Support FDA new and ongoing submission processes and associated departments
Assist in the development of cGMP operating procedures that relate to process, computer systems, equipment validation, medical devices and 510(k) regulatory processes
Review all change requests for changes that impact medical devices
Be a regular impact assessor of all medical device-related changes within Biomat USA
Collaborate with other departments within the organization and act as liaison for quality and regulatory items associated with medical devices
Ensure milestones and timelines are met on assigned projects
Knowledge, Skills and Abilities:
Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures.
Excellent quantitative and analytical skills.
Excellent oral and written communication skills.
Strong critical thinking and problem solving skills.
Ability to identify errors and provide corrective action.
Ability to work with others in a team environment.
Knowledge of Microsoft Office applications and computer applications used in the Donor Centers.
Education and Experience:
Typically requires 2 years of quality and validation experience in a cGMP and/or IT environment.
Occupational Demands Form # 34: Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32
- and high levels of noise in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. May stand; bends and twists neck and waist for 2-4 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Repetitive foot movements. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols
Req ID: 381947
Type: Indefinido tiempo completo
Job Category: Producción en industria Química/Farmacéutica