Quality Specialist
3 weeks ago
POSITION OVERVIEW: The Quality Specialist will be expected to use training,experience, and good judgement to perform tasks assigned in the Quality Department.
This position is located in San Ramon, CA. This is not a remote position.
JOB RESPONSIBILITIES:
- Initiates and/or reviews and approves minor deviations; completes tasks related to CAPA and Change Control action items.
- Assist Complaint program at Atlas Lift Tech including tracking, trending, and updating associated metrics.
- Completes Regulatory Risk Assessments related to Complaints.
- Maintain the supplier activities and implementation of them into the Quality Management System. Review trends and data on suppliers and discuss with the
- Quality manager any issues that need to be addressed.
- Assist with Root Cause Analysis
- Responsible for document control
- Responsible for the revision, distribution and maintenance of controlled documents including Standard Operating Procedures, Work Instructions, Forms, specifications, and other miscellaneous documents.
- Assist in preparation, submission, and maintenance of regulatory filing documents with the appropriate local, state, and federal agencies.
- Responsible for maintaining controlled document libraries.
- Coordinate requests for Change Orders, including preparing supporting documentation, communications, sample part review and scheduling for projects in engineering and quality.
- Conducts process walks of procedures with other departments.
- Contributes to team effort by accomplishing related tasks as needed. Will be required to perform other duties as required, directed, or assigned.
Education and Experience:
- Thorough knowledge and minimum 3 years’ experience working in a regulated environment such as medical devices and experience with Quality Management
- Systems and Medical Device Regulations: CFR 820, ISO 13485
- Ability to prioritize and shift priorities quickly as needed.
- Team-oriented with commitment to the success of the team and organizational goals to track.
- Certification in Quality field preferred.
- Experience working with manufacturing-based technology processes and principles preferred.
- Must have good verbal and written communication skills.
- Ability to multitask
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