Quality Assurance Specialist

2 weeks ago

Sunnyvale, California, United States CathX Medical Full time
Job Overview

SUMMARY:

The Quality Assurance Technician plays a crucial role in supporting the quality management system by conducting thorough inspections of products throughout all stages of development and production.


KEY RESPONSIBILITIES:

  • Conduct quality control inspections, including assessments of incoming materials, in-process components, and final products.
  • Operate semi-independently to execute tasks with minimal supervision.
  • Ensure compliance with all relevant Standard Operating Procedures (SOPs) and adhere to necessary gowning and hygiene protocols.
  • Provide training on manufacturing processes as required.
  • Maintain precise records of quality inspections and related documentation.
  • Support the Material Review Board (MRB), purchase order evaluations, and product release processes.
  • Assist in the upkeep of an accurate document control system and manage equipment calibration.
  • Collaborate with Engineering, Manufacturing, and Quality teams to facilitate equipment validation activities, including verification inspections and testing.

SUPERVISORY ROLE:

This position does not include supervisory responsibilities.


REQUIRED COMPETENCIES:

  • Interpersonal Skills: Maintains effective relationships with colleagues.
  • Communication: Listens attentively and communicates clearly in both written and verbal forms; able to interpret technical documentation.
  • Team Collaboration: Balances individual and team responsibilities, contributing positively to team dynamics.
  • Planning and Organization: Efficiently manages time and resources to meet objectives.
  • Professionalism: Engages with others respectfully and handles pressure with composure; takes ownership of actions and commitments.

QUALITY FOCUS:

  • Demonstrates meticulous attention to detail and seeks opportunities to enhance quality standards.
  • Safety Awareness: Adheres to safety protocols and reports any hazardous conditions.
  • Adaptability: Adjusts to changes in the work environment and manages competing priorities effectively.
  • Dependability: Follows instructions diligently and completes tasks punctually.
  • Initiative: Proactively engages in self-development and offers assistance when needed.
  • Innovation: Proposes ideas for process improvements.

QUALIFICATIONS:

To be successful in this role, candidates must demonstrate the ability to fulfill each essential duty effectively. The qualifications listed below represent the necessary knowledge, skills, and abilities required. Reasonable accommodations may be made for individuals with disabilities.


EDUCATION AND EXPERIENCE:

A High School Diploma or GED is required, along with a minimum of 5 years of experience in the medical device sector, specifically in quality control inspection. A basic understanding of drawings and specifications is essential.


LANGUAGE PROFICIENCY:

Ability to read and interpret safety regulations, operational instructions, and procedural manuals.


MATH SKILLS:

Competence in basic mathematical calculations, including decimals, addition, subtraction, multiplication, and division.


REASONING ABILITY:

Ability to apply common sense and follow detailed instructions; capable of addressing problems with a few concrete variables in standardized situations.


OTHER SKILLS:

Proficient in using measurement tools such as microscopes and pin gauges, and comparing measurements against established standards.


PHYSICAL REQUIREMENTS:

The physical demands outlined here are representative of those that must be met by an employee to successfully perform the essential functions of this role. Reasonable accommodations may be made for individuals with disabilities.

While performing the duties of this position, the employee is regularly required to stand, use hands for manipulation, reach with arms, and communicate verbally. The employee frequently walks and occasionally sits, stoops, kneels, crouches, or crawls. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds. Specific vision requirements include close vision, distance vision, color vision, depth perception, and the ability to adjust focus.


WORK ENVIRONMENT:

The characteristics of the work environment described here are representative of those an employee may encounter while performing the essential functions of this job. Reasonable accommodations may be made for individuals with disabilities.


While executing the responsibilities of this role, the employee is regularly exposed to moving mechanical parts and occasionally to fumes, airborne particles, and hazardous chemicals. The noise level in the work environment is moderate.

Job Posted by CathX Medical

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