Metrologist

Metrologist – Medical Device Manufacturing

Full-Time | Onsite (8:00 AM – 5:00 PM)

Location: Upland, California

Join a global leader in medical device design and manufacturing services, partnering with innovative customers to deliver high‑quality, life‑enhancing medical technologies.

• Design fixtures, develop measurement methods, and perform measurement system analysis.
• Adhere to safety, quality, and regulatory requirements including QMS, EMS, and FDA regulations.
• Program inspection routines to support injection molded and assembled components.
• Assess and implement improvements to NPI inspection routines and fixtures for throughput.
• Participate in review of manufacturing and testing of new products to ensure quality compliance.
• Provide training on new procedures as needed.
• Support Inspection Function and train employees engaged in inspection and testing activities.
• Own CAPA, Complaints, Calibration OOT, and Non‑Conformance events from initiation to closure.
• Generate inspection sheets and control plans to meet customer drawing and specification requirements.
• Assure compliance to internal 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 required.

• 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

• 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 Solid Works 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 reading and interpreting blueprints.
• Familiarity with GDT (Geometric Dimension & Tolerance) requirements.
• Perform various computer related tasks and programs including but not limited to:
  Microsoft Office Suite, Solid Works, Minitab, ETQ, IQMS, Infinity QS, MEASURE MIND, 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 21 CFR 820, ISO 13485:2016).

• Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or lifting, carrying, pushing, pulling, or moving objects.

• Short Term:
  Learn building routines, CMM machine operations, and sustaining processes.
• Long Term:
  Contribute expertise to New Product Introduction (NPI) programs.

• Solid Works, OGP Smart Scope.
• Report writing, Office 365.
• ERP systems (similar to IQMS), ETQ (QMS tool), Minitab.
• Preferred experience in injection molding, Test method validation.

• OGP Smart Scope – Zone 3 Software.
• CMM Programming.
• GD&T Interpretation.
• Test Method Validation.
• Data Analysis / Minitab.
• Industry (Medical Device).
• Customer-Facing Experience.
• Aerospace or automotive is good – Medical device.

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