Quality Assurance - Quality Inspector/Technician

Viant Medical LLC

Collegeville, PA

JOB DETAILS
SKILLS
Analysis Skills, Capability Maturity Model (CMM), Code of Federal Regulations, Communication Skills, Corporate Policies, Data Analysis, Documentation, Electronic Measuring Tools, Environmental Management Systems, FDA (Food and Drug Administration), FDA Requirements, Geometric Dimensioning and Tolerancing, Hand Tools, High School Diploma, ISO (International Organization for Standardization), Identify Issues, Machine Tool, Maintain Compliance, Manufacturing, Onboarding, Operations Processes, Organizational Skills, Presentation/Verbal Skills, Problem Solving Skills, Quality Assurance, Quality Control, Quality Management, Quality Metrics, Regulatory Requirements, Resource Conservation and Recovery Act (RCRA), Safety Training, Team Player
LOCATION
Collegeville, PA
POSTED
3 days ago

Position Scope/Summary:

The primary purpose of this position is to perform standardized measurements of parts in-process involving prescribed measurement tools under guided supervision. 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.

Accountabilities & Responsibilities:

  • Adheres to all safety and quality requirements including, but not limited to: Quality
  • Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
  • Uses standard measuring tools, measuring machines, and electronic instruments to perform inspections in accordance with authorized specification and quality control standards.
  • Performs analysis using standard or custom procedures to make accept/reject decisions.
  • Performs basic troubleshooting, as necessary. Develops solutions for technical problems of limited scope.
  • May be required to work beyond the scheduled shift end time based on customer or business needs. Such needs may arise on short notice, and the associate is expected to accommodate as required. Sets up and runs measurement systems with direction.
  • Uses judgement and problem-solving skills to provide input in the evolution of measurement equipment, systems and processes.
  • Works in individual and team settings with guidance as needed.
  • Prepares necessary documentation and ensures paperwork compliance on all inspected items, including filing, scanning and verification of device history records.
  • Interacts professionally with other departments to provide data, analysis results and decisions.
  • Performs other functions as required.

Position Requirements:

  • Minimum Education: High School diploma or equivalent. Associate's Degree in a technical field or other technical degree preferred.
  • Minimum Experience: 2-5 years of experience in manufacturing or regulated industry.

Knowledge & Skills:

  • 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.

Environmental Working Conditions:

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The employee is occasionally exposed to high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; and vibration. The noise level in the work environment is usually moderate.

It is impossible to list every requirement for, or responsibility of, any position. Similarly we cannot identify all the skills a position may require since job responsibilities and the Company's needs may change over time. Therefore, the above job description is not comprehensive or exhaustive. The Company reserves the right to adjust, add to or eliminate any aspect of the above description. The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.

The associate must successfully complete the general RCRA Awareness training through the onboarding training process upon their start at Viant followed by an annual refresher. If the associate changes their position or begins to handle larger quantities of chemical waste (Above 20 gals) at a time, additional training will be required.

About the Company

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Viant Medical LLC