San Diego Metro Area, CA
We are currently seeking a Quality Specialist 1 who will be responsible for supporting and working within the Product Assurance Release team.
Responsible for ensuring compliance with applicable domestic and international standards and regulations through audits and systematic maintenance of effective quality systems.
Ensure that deadlines are met on time and within budget.
Limited interface with other departments and business or marketing partners.
Work independently with limited supervision and exercise judgment within the defined procedures and practices to determine appropriate actions.
Conduct compliance audits of less complex documentation and data and approve use of Design History Records, Device Master Records, Nonconformance, Document Changes, Validations and Change Controls.
Demonstrate working knowledge of Quality Control, Manufacturing and Inventory processes.
Serve as QA interface with limited responsibilities to other departments.
Prepare data packages for external customers (Business or Marketing partners) and regulation bodies.
Perform compliance activities such as Product Holds, room releases, etc.
Supports internal and/or external audits in compliance with ISO 13485 and 21CFR820 requirements.
Participates in 3rd Party Audits from regulatory bodies including the FDA, notified bodies and business partners.
Assists in developing quality systems & make recommendations for improvements to existing Quality systems.
Develops, analyze, trends, maintains & reports department metrics.
Perform special assignments as designated by the supervisor/manager.
Performs other relevant duties as assigned.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required:
Basic understanding of QSR & ISO requirements
Basic knowledge of QC, Manufacturing & Inventory processes
Organizational skills, attention to detail and ability to prioritize in a fast paced environment is essential.
Must demonstrate initiative, balanced assertiveness, flexibility and team orientation.
Working knowledge of Microsoft Word, Excel, Power Point and related functions including the formulation of graphs
May occasionally lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects of a negligible weight frequently or continuously.
Sedentary work involves sitting the majority of time.
Jobs are sedentary if walking and standing are required only occasionally.
Requires BA or BS in a biological or chemical science.
Quality certification (from American Society for Quality or equivalent), is a plus.
2-3 years related quality experience.