Quality Inspector II

Quality Inspector II

Viant Medical is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources.

This is a mid-level position. The Quality Inspector II is primarily responsible for supporting Quality Control functions by providing the necessary skills needed in the following requirements. The Inspector shall facilitate mold test first articles, new tool validation studies, and review new customer drawings and specifications for adequacy. The Inspector is responsible routines generation of Smart Scopes, SPC Analysis, any process improvement and/or administrative support activities, adherence to good metrology practices and site Quality Management System procedures.

Main Job Responsibilities:

• Support and uphold the Viant Values: Customer Oriented, Integrity, Servant Leadership, Own It, Teamwork, and Be Agile.
• Treat employees with dignity and respect.
• ATTENDANCE IS PARAMOUNT. All associates are required to report to their scheduled shift on time and work their entire shift.
• Maintain a professional attitude towards coworkers and company.
• Put safety first. Ensure employees are working safely and all safety measures and procedures are being met and followed. Including good housekeeping.
• Adhere to company policies and procedures.
• Must comply with the company's quality system, GMP, SOP and follow work instructions and all safety policies.
• Must be able to meet all company documentation requirements.
• Adherence to GMP, ISO, and organizational SOPs.
• Maintain clean working environments throughout quality department areas.
• Other duties as assigned by supervisor or lead.
• Perform or otherwise execute mold qualification and validation activities.
• Coordinate and conduct CpK Studies, Gage R&R and special customer requests.
• Assist in special project defined by Quality, Engineering and Manufacturing.
• Review customer blue prints, specifications and inspection plans for adequacy.
• Monitoring and improvement of SPC systems, sampling plans and statistical methods.
• Perform basic ERP transactions
• Write basic NCRs and place product on hold
• Approve Certs of Compliance

Expectation:

• Develop skills to perform basic, repetitive and manual activities in the job.
• Use existing procedures to solve straightforward problems.
• Master all requirements of Quality Inspector II in order to advance to Quality Inspector III.

Requirements:

Education/Certification:

• High school diploma and some technical training through college or technical field or equivalent work experience.

Experience:

• Must be 18 years of age
• 3 - 5 years of related experience

Skills/Competencies:

• Ability to use Inspection tools (Calipers, Micrometers, Handheld Gages, Instron, Smart Scope..)
• Basic math and reading comprehension
• Basic computer skills
• Working knowledge of Excel and database programs (Infinity QS)
• Ability to read and assess drawings
• Ability to correctly select and use sampling plans
• Demonstrate understanding of basic Quality Systems Regulations
• Good verbal communication and organizational skills.

Physical Requirements:

• Light work: Exerting up to 50 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or lift, carry, push, pull, or move objects.
• Excellent vision & hand-eye coordination
• Extended periods of bending, lifting, standing, and sitting
• Significant use of hands
• Frequently required to lift up to 50 lbs
• Must be able and willing to wear personal protective equipment as required including:
• Protective eyewear
• Hair net
• Protective gowning (lab coat, hood)

Work Conditions:

• Climate Controlled in the summer months
• Clean Room Environment (hospital grade cleanliness)
• Clean, Comfortable Setting