What are the responsibilities and job description for the Equipment Calibration Engineer / Medical Devices (JK456) position at Pioneer Data Systems, Inc.?
Position Details :
Our client, a world-leading Pharmaceutical Company in Santa Clara, CA is currently looking for an Equipment Calibration Engineer to join their expanding team.
Job Title : Equipment Calibration Engineer / Medical Devices
Duration : 6 months contract, extendable up to 24 months
Location : Santa Clara, CA
Note :
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description : 100% Onsite
Can start between 7am and 9am
The Equipment Calibration and Preventive Maintenance Engineer will support the equipment maintenance and calibration programs at the Santa Clara site.
He or she 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.
Duties and 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, 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.
Required Skills and Experience :
Minimum 2 years of proven performance ability working as an Equipment Calibration Engineer or Sr. Equipment calibration Technician in a high-volume manufacturing environment
Experience in review & approval of specification of Calibration, Maintenance, and qualification documentation
Able to analyze data, compile reports, and recommend corrective action
Basic knowledge in the areas of Design Controls Processes, Equipment Validation, Manufacturing practices / principles, and statistical techniques
Outstanding organization, communication, presentation, and interpersonal skills working within the organization
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
Preferred Skills and Experience :
Experience working in the medical device field
Experience with computerized management systems, such as SAP, Maximo, BMRAM or CERDAAC or equivalent
Solid understanding of ISO 9001 / 13485, 21 CFR 820, cGMP, GXP and good documentation practices
Efficiency with Microsoft Office Products such as Word and Excel or equivalent software application
