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Quality Control Technician

3 months ago

Tucson, United States HRPivot Full time
Job DescriptionJob Description

Quality Control Technician

Sign On Bonus Offered -
Here at SynCardia, we have a very special mission: to give end-stage heart failure patients the priceless gift of more time. More time with their families and friends, more time outside the hospital enjoying life, and more time to receive a heart transplant.

As one of our Quality Control Technicians, you will be responsible for inspecting incoming materials, purchased items, subcontracted parts, and finished goods based on documented requirements and determining acceptance or rejection.

Duties and Responsibilities

  • Identify solutions and/or complete assigned tasks related to the resolution of corrective and preventive actions, internal audit findings, and non-conformance reports.
  • Monitor, trend and evaluate results of quality monitoring processes including bioburden, pyrogen, and NCR trend data.
  • Evaluate and investigate as necessary results of the monitoring process and communicate the information in appropriate formats including basic statistical summaries and trend charts.
  • Maintain cleanliness of QC lab.
  • Oversee quarantine cage and disposition materials as required.
  • Enforce “controlled room” policies and procedures.
  • Ensure that finished devices consistently meet required quality standards based on documented requirements.
  • Inspect all incoming materials for use in the manufacturing of medical devices, evaluate the quality of materials and determine acceptance or rejection of these items based on documented requirements.
  • Inspect purchased items and subcontracted parts and subassemblies intended for use in medical device manufacturing processes or systems based on documented requirements.
  • Inspect finished goods and release them to inventory based on documented requirements.
  • Inspect device history records to ensure compliance with procedural and regulatory
  • requirements prior to the release of finished goods.
  • Review, write, and revise quality control specifications or acceptance criteria as needed
  • and generate required supporting documentation to implement the revision.
  • Document and communicate results of acceptance activities per approved and applicable quality system procedures, forms, and/or other documents.
  • And all other duties as assigned.

Responsibility and Authority Affecting Quality

  • Initiate action to prevent the occurrence of nonconformities relating to the product, process and Quality System.
  • Identify and record potential problems relating to the product, process, and Quality System.
  • Initiate, recommend or provide solutions through designated channels.
  • Record and/or report all instances of customer feedback on the product.

Position Requirements

  • Ability to work independently and to carry out assignments to completion within parameters of instructions given prescribed routines, and standard accepted practices.
  • Ability to demonstrate consistent punctuality and attendance.
  • Ability to perform measurements and tests using standard equipment.
  • Comprehensive knowledge in interpreting blueprint reading and interpretation.
  • Ability to maintain accurate records.
  • Ability to effectively communicate both verbally and orally.
  • Strong organizational skills.
  • Strong attention to detail.
  • Collaborates well with others by proactively contributing to group objectives; volunteers to help others.
  • Must possess a proficient ability to read, write, comprehend, and speak English

Education, experience

  • Associate’s degree, technical training/certifications or equivalent
  • 1-3 years of quality inspection in a manufacturing environment or equivalent
  • Cleanroom – One to three years’ experience (preferred)
  • Training in FDA QSR, ISO 13485 and MDSAP
  • cGMP experience (preferred)
  • Proficient computer skills, i.e. Microsoft suites

*Working Environment is a Controlled Environment Suite (CES)

  • The working environment is indoors and is seasonally heated and cooled with minimal noise levels.
  • The position requires considerable sitting, typing and the ability to move objects of less than 25 pounds.
  • The position requires the ability to communicate in person, telephonically and via email.
  • Additional restrictions regarding work in the laboratory environment:
  • No facial cosmetics or fragrances.
  • Personal items stored outside lab (phones, jewelry, watches, etc.).
  • No food or drink at any time
  • Adherence to strict requirements regarding special, protective clothing or any other personal protective equipment (PPE).

SynCardia Systems, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Job Type: Full-time

Pay: $21.00 - $25.00 per hour

Benefits:

  • Dental insurance
  • Health insurance
  • Vision insurance

Experience level:

  • 1 year

Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday

Work setting:

  • In-person
  • Manufacturing facility
  • Office
  • Warehouse

Ability to commute/relocate, location:

  • Tucson, AZ 85713: Reliably commute or planning to relocate before starting work (Required)

Education:

  • Associate (Preferred)

Experience:

  • Manufacturing: 1 year (Preferred)
  • CGMP: 1 year (Preferred)
  • FDA regulations: 1 year (Preferred)
  • ISO 13485: 1 year (Preferred)
  • MDSAP: 1 year (Preferred)
  • Quality control: 1 year (Required)
  • Quality inspection: 1 year (Required)

Shift availability:

  • Day Shift (Required)

Work Location: In person

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