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Quality Technician

3 months ago

Sunnyvale, United States CathX Medical Full time
Job DescriptionJob Description

SUMMARY:

Support the quality management system program by performing inspections on product at all phases of development and manufacturing.


ESSENTIAL DUTIES AND RESPONSIBILITIES:

Include the following. Other duties may be assigned.

  • Perform the quality control inspection function, including all incoming, in-process, and finished product inspections.
  • Works semi-independently to perform operations under minimal
  • Compliance to all applicable Standard Operating Procedures (SOPs) and adherence to CER gowning and personnel hygiene requirements.
  • Ability to train on manufacturing
  • Maintain accurate quality inspection records and record of
  • Assist with Material Review Board (MRB), PO review, and product release as
  • Assist in maintaining an accurate document control system and equipment calibration
  • Assist Engineering, Manufacturing and Quality in support of equipment validation activities, including verification inspection/testing activities.

SUPERVISORY RESPONSIBILITIES:

This job has no supervisory responsibilities.


COMPETENCIES:

To perform this job successfully, and individual should demonstrate the following competencies:

  • Interpersonal Skills - Maintains
  • Oral and Written Communication - Listens and gets Writes clearly and informatively; Able to read and interpret written information.
  • Teamwork - Balances team and individual responsibilities; Contributes to building a positive team spirit.
  • Motivation and Planning/Organizing - Measures self against standard of Uses time efficiently.
  • Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.

Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

  • Safety and Security - Observes all safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials
  • Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent changes, delays, or unexpected events.
  • Attendance/Punctuality - Is consistently at work on time; Arrives at meetings and appointments on time.
  • Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
  • Initiative - Volunteers readily; Undertakes self-development activities; Asks for and offers help when needed.
  • Innovation - Generates suggestions for improving

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.


EDUCATION and/or EXPERIENCE:

High School Diploma and/or GED or minimum of 5+ years experience in medical device industry performing quality control inspection activities. Basic drawing and specification understanding.


LANGUAGE SKILLS:

Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals.


MATHEMATICAL SKILLS:

Must have the ability to calculate figures and amounts using basic math (i.e. decimals, addition, subtraction, multiplication and division).


REASONING ABILITY:

Have the ability to apply common sense; Understanding to carry out detailed but uninvolved written or oral instructions; Ability to deal with problems involving a few concrete variables in standardized situations.


OTHER SKILLS and ABILITIES:

Ability to use measurement tools like microscopes and pin gauges and to compare measurements to documented standards.


PHYSICAL DEMANDS:

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

While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee is frequently required to walk. The employee is occasionally required to sit and stoop, kneel, crouch, or crawl. 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 abilities required by this job include close vision, distance vision, color vision, depth perception and ability to adjust focus.


WORK ENVIRONMENT:

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


While performing the duties of this job, the employee is regularly exposed to moving mechanical parts. The employee is occasionally exposed to fumes or airborne particle and toxic or caustic chemicals. The noise level in the work environment is moderate.



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