Full-Time | Onsite (8:00 AM – 5:00 PM)
Location: Fremont California
Join a global leader in medical device design and manufacturing services, partnering with innovative customers to deliver high‑quality, life‑enhancing medical technologies.
We are seeking a Metrologist!
Responsibilities:
- Designing and testing fixtures, developing measurement methods, and performing measurement system analysis.
- Adheres to all safety and quality requirements including, (QMS), (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
- Program inspection routines to support injection molded and assembled components.
- Assess and implement improvements of production and NPI inspections routines and fixtures to increase throughput.
- Participate in the review of the manufacturing and testing of new products to assure quality requirements are fulfilled.
- Provide training as needed on new procedures being enforced.
- Support Inspection Function, training employees engaged in inspection and testing activities to ensure compliance to procedures and policies.
- Own CAPA, Complaints, Calibration OOT and Non-Conformance events from initiation to closure.
- Responsible for generating Inspection sheets and control plans to meet customer drawing and specification requirements.
- Assures compliance to in-house and external specifications and standards, such as GMPs and ISO regulations.
- Interface with customers, vendors, and 3rd party assessors, as needed.
- Support Internal, Customer and Regulatory body audits as needed
- Bonus structure
- Medical, dental, and vision benefits-effective date of hire!
- Company-paid life insurance and disability benefits
- PTO 10 paid holidays
- 401k Plan with Company Match
- Tuition reimbursement
- Opportunity to grow
- Additional voluntary benefit options
Typical Day/Week:
- Perform equipment and building testing.
- Conduct quality engineering tasks including customer interactions and SME collaboration.
- Validate test methods and analyze inspection data.
- Lead technical discussions with customers across regions.
- Use SolidWorks for model generation and program OGP Smart Scope.
- Bachelor of Science degree in Engineering or related field
- 5 years of experience in injection molding or similar manufacturing industry.
- Preferred: Medical Device industry
- Knowledge and familiarity with OGP (Optical Gauging Product), CMM (Coordinate Measuring Machine) and other measuring devices used to ensure quality and acceptability of the product.
- Proficient with the ability to read and interpret blueprints.
- Familiarity with GDT (Geometric Dimension & Tolerance) requirements.
- Perform various computer related tasks and programs including but not limited to: Microsoft Office Suite, SolidWorks, Minitab, ETQ, IQMS, Infinity QS, MEASUREMIND, Zone3 and CALYPSO.
- Strong organizational skills with proven ability to complete multiple tasks simultaneously.
- Solid understanding of Quality Management System Regulations (complaint, NCR, containment, root cause, etc.)
- Strong working knowledge in the interpretation and application of relevant Regulations and Industry Standards (e.g., FDA 21CRF820, ISO 13485:2016)
- Physical Requirements: Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or lift, carry, push, pull, or move objects
Objectives:
- Short Term: Learn building routines, CMM machine operations, and sustaining processes.
- Long Term: Contribute expertise to New Product Introduction (NPI) programs.
Tools & Technologies Used:
- SolidWorks, OGP Smart Scope
- Report writing, Office 365
- ERP systems (similar to IQMS), ETQ (QMS tool), Minitab
- Preferred experience in injection molding, Test method validation
Requirements
- OGP Smart Scope - (Zone 3 Software)
- CMM Programming
- GD&T Interpretation
- Test Method Validation
- Data Analysis / Minitab
- Industry (Medical Device)
- Customer-Facing Experience
- Areospace or automotive is good – Medical device
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