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Quality Assurance - Quality Inspector

Viant

Fort Wayne, INOnsitePosted 1 day ago
Full TimeEntry LevelQuality (QA / QC)Medical Device
Original posting ↗

Summary

This position will work to maintain elements of Quality Management Systems (QMS) in accordance with ISO 13485 and FDA 21 CFR 820 requirements as well as company protocols.

Job description

Position Summary

This position will work to maintain elements of Quality Management Systems (QMS) in accordance with ISO 13485 and FDA 21 CFR 820 requirements as well as company protocols.

Job Responsibilities

  • Adheres to company safety policies and programs such as Personal Protective Equipment, Incident/Injury Reporting, Hazard Communication and Labeling.
  • Reads and interprets blueprints.
  • Manage daily work load 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.
  • Maintains documentation and paperwork to include accurate counts of parts.
  • Notifies supervisor of product discrepancies or equipment malfunctions immediately.
  • May help train new employees as required.
  • Performs other related duties as assigned.

Job Requirements

Knowledge/Education: High school diploma or equivalent.

Experience: 2+ years inspection experience in medical device or regulated manufacturing.

Preferred Certifications: NDT Level 1 or 2 certified with proof of certification. ASNT SNT-TC-1A ASNT CP-189.

Skills/Competencies

  • Ability to read and interpret drawings/prints.
  • Has basic knowledge in the use of hand gages, tool scopes and height stands.
  • Experience measuring physical dimensions on parts.
  • Ability to interpret and apply GD&T to measurement methods.
  • Experience with Vision-based CMM systems preferred.
  • Ability to read and understand work instructions.
  • Good verbal communication and organizational skills.

Requirements

  • High school diploma or equivalent
  • 2+ years inspection experience in medical device or regulated manufacturing
  • Ability to read and interpret drawings/prints
  • Basic knowledge in the use of hand gages, tool scopes and height stands
  • Experience measuring physical dimensions on parts
  • Ability to interpret and apply GD&T to measurement methods
  • Ability to read and understand work instructions
  • Good verbal communication and organizational skills

Benefits

  • Medical, Dental & Vision
  • Paid Time Off
  • 10 Paid Holidays
  • Paid Lunch Time
  • Company-paid Life Insurance
  • 401(k) Matching
  • Attendance Bonus
  • Nutrition & Mental Health Visits
  • Gym Membership Discount
  • Pet Insurance
  • Financial Planning Meetings
  • Employee Discount Program
  • Family Caregiving Support
  • Tuition Reimbursement
  • On-site Training Programs
  • Career Path Advancement

Company overview

Viant is a global medical device design and manufacturing services provider that partners with customers to deliver high-quality, life-enhancing medical devices. With over 6,000 associates across 25 locations worldwide, the company offers end-to-end solutions encompassing design, development, manufacturing, assembly, and packaging services. Viant specializes in surgical technologies, orthopedics, cardiac & interventional devices, bioelectronics, bioprocessing, drug delivery systems, diagnostics, and respiratory monitoring products. The company operates 2.3 million square feet of facility space, including 300,000+ square feet of cleanroom environments, and maintains extensive capabilities in precision machining, polymer processing, and metal tubing production. Viant's vertically integrated supply chain and global footprint enable customers to optimize costs while accelerating time-to-market for innovative medical technologies. The company's name is rooted in the Latin word for life, reflecting its commitment to improving patient outcomes through advanced medical device solutions.

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