Medical Device Quality Inspector | ISO 13485 Focus

Viant Medical Inc.; Fort Wayne (IN); On-site; USD 42,000 - 60,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

136 Hours PTO (prorated based on hire)

Company-paid life insurance

401k plan with company match

Attendance bonus up to $800 annually

Gym membership discount up to $150

Pet insurance discounts

Financial planning meetings

Employee discount program

Discounted family caregiving support

Tuition reimbursement

On-site Training Programs

Defined Career Path for advancement

New Hire On-boarding Training Plans

Job summary

Viant Medical Inc. inspects medical devices and maintains quality management standards to ensure regulatory compliance and product quality. The role supports ISO 13485 and FDA 21 CFR 820 adherence in daily operations on the production floor.

Ideal candidates have 2+ years of inspection experience in regulated manufacturing, with strong GD&T, blueprint reading, and CMM skills to ensure accurate dimensional measurements and documentation.

Qualifications

• High school diploma or equivalent.
• 2+ years inspection experience in medical device or regulated manufacturing.
• NDT Level 2 certified with proof of certification.
• ASNT SNT-TC-1A
• ASNT CP-189

Responsibilities

• Adheres to safety policies and programs such as Personal Protective Equipment.
• Reads and interprets blueprints.
• Manage daily workload under minimal supervision to meet expected personal/department goals.
• Maintain an organized workspace and perform line clearance activities consistently.
• Communicate with co-workers respectfully and professionally.
• Complete required documentation and inspection operations with detail, accuracy, and precision.
• Maintain the focus needed to complete tasks in a timely, efficient, and accurate manner.
• Notifies supervisor of product discrepancies or equipment malfunctions immediately.
• May help train new employees as required.

Skills

Read drawings

GD&T knowledge

Vision-based CMM

Gages & height stands

Verbal communication

Education

High school diploma or equivalent

Tools

CMM systems

Job description

Viant Medical Inc. inspects medical devices and maintains quality management standards to ensure regulatory compliance and product quality. The role supports ISO 13485 and FDA 21 CFR 820 adherence in daily operations on the production floor.

Ideal candidates have 2+ years of inspection experience in regulated manufacturing, with strong GD&T, blueprint reading, and CMM skills to ensure accurate dimensional measurements and documentation.