Overview
Quality Analyst Jobs in Santa Clara, CA at Johnson & Johnson
Title: Quality Analyst
Company: Johnson & Johnson
Location: Santa Clara, CA
Johnson & Johnson Family of Companies
Title: Quality Medical Device Specialist
Location: Santa Clara, CA
Duration: 6 months
Pay Rate: $51.53
Benefits on offer for this contract position: Health Insurance, Life insurance, 401K and Voluntary Benefits
Please note that this is a contract role providing services to the Johnson & Johnson Family of Companies through external staffing partners of Kelly OCG. If you are selected for this role, you will be employed by a contract staffing supplier and will not be a member of the Johnson & Johnson Family of Companies.
Summary:
The Equipment Calibration and Preventive Maintenance Engineer will support the equipment maintenance and calibration programs at the Santa Clara site. The candidate will ensure compliance of these programs, provide investigation and nonconformance support and drive continuous improvement efforts. The position acts as a technical advisor on all equipment issues. Additional responsibilities may include performing process improvement projects. This position reports to the Equipment calibration and PM Manager.
Responsibilities:
Works directly with customers, engineering, manufacturing and other groups to develop appropriate equipment
specifications for calibration and preventative maintenance (PM), such as parameters, intervals, tolerances, acceptance criteria, and operating limits for new and existing equipment and systems.
Review all equipment specifications and records information for completeness and appropriateness.
Provides communication, direction, mentoring, training, and guidance for employees.
Review and approval of Calibration, preventative maintenance (PM), documents and reports.
Manages service providers to ensure scheduling in accordance with Cal and PM due dates; coordinates the testing, monitoring, and inspecting processes of equipment calibration and PM
Collect, report, and maintain calibration and preventive maintenance performance data into Computerized Maintenance Management System (CMMS).
Collaborates with multi-functional groups to resolve calibration/maintenance issues, support non-conformance
investigations, improve equipment reliability, review procedures, and minimize equipment downtime.
Participates in product, project, and process development teams to provide quality support and mentorship.
Supports all audits.
Other related duties may be assigned
Qualifications:
Bachelor’s degree in Engineering or technical certifications in a related field is required.
Minimum 2 years of proven performance ability working as an Equipment Calibration Engineer or Sr. Equipment calibration Technician in a high-volume manufacturing environment is required
Experience in review & approval of specification of Calibration, Maintenance, and qualification documentation is required
Able to analyze data, compile reports, and recommend corrective action is required
Basic knowledge in the areas of Design Controls Processes, Equipment Validation, Manufacturing practices/principles, and statistical techniques is required
Must have outstanding organization, communication, presentation, and interpersonal skills working within the organization
Must be able to work independently, efficiently, and collaboratively with all levels of employees and management
Flexibility to support changing assignments and priorities in an independent and reliable manner while maintaining a positive and collaborative demeanor is required
Experience working in the medical device field is preferred
Experience with computerized management systems, such as SAP, Maximo, BMRAM or CERDAAC or equivalent is preferred
Solid understanding of ISO 9001/13485, 21 CFR 820, cGMP, GXP and good documentation practices is preferred
Efficiency with Microsoft Office Products such as Word and Excel or equivalent software application is preferred
