- 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
- 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 Engineer or Sr. Equipment 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
- Ability to travel and work at local sites (e.g. Redwood City, Santa Clara, and San Jose)
- Preferred Skills and Experience:
- Experience working in the medical device field
- Certified ISO 9001/13485
- Experience with computerized management systems, such as SAP and CERDAAC or equivalent
- Solid understanding of 21 CFR 820, cGMP, GXP and good documentation practices
- Efficiency with Microsoft Office Products such as Word and Excel or equivalent software application
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Quality Equipment Engineer - Santa Clara, United States - Pyramid Consulting
Description
Immediate need for a talented Quality Equipment Engineer. This is a 06+ Months contract opportunity with long-term potential and is located in Santa Clara, CA (Onsite). Please review the job description below and contact me ASAP if you are interested.
The full job description covers all associated skills, previous experience, and any qualifications that applicants are expected to have.
Job ID:
Pay Range: $42 - $50/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
Key Requirements and Technology Experience:
Our client is a leading Pharmaceutical organization and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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