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Quality Technician II

North Tustin, CA 92705

Posted: 06/06/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 554805 Is job remote?: No Country: United States

Job Description

HM's Top Needs:
  • Must be able to small detect defects under a microscope
  • Defects such as thin peeling of tissue on the first layer of the heart valve. A
  • MicroVu experience Heart valve manufacturing is a unique environment. Candidate must be ok with the smell of tissue or chemical and work inside a cleanroom while sitting for long period of time.

Responsibilities includes
  • Perform incoming inspection activities such as
  • dimensional verification with the use of a MicroVu and caliper Testing of raw materials/components Data analysis Visual inspection of stent frames under a microscope
  • Perform in-process inspection activities such as
  • Dimensional verification of implantable device (heart valves) Testing of final implantable device (heart valves) Visual inspection on implantable device (heart valves)
  • Perform incoming inspection release and final release activities Assist engineers in performing root cause investigation Process change orders in the document system
  • Yearsa Experience Required: 2+, experience with handling tissue/inspection is a plus. Will the contractor be working 40 hours a week? Yes, 40 hrs/week Work Location: Full time Onsite

Responsibilities may include the following and other duties may be assigned.
Performs analyses, inspection, and tests of raw materials, packaging materials, quantitative assays on samples, and/or finished products (Implants) from manufacturing, to ensure quality standards and compliance to customer and regulatory requirements, and tolerance specifications for the chemical or physical property. Performs a variety of qualitative tests or qualitative assays on samples, and to aid in maintenance and certification of test instruments and apparatus to ensure compliance. Performs required inspections on heart valves and raw material, checks, analysis and documentation of studies and build plans. Reviews production records for conformance to procedures. Conduct product acceptance testing. TECHNICIAN SUPPORT CAREER STREAM: Provides technical support in areas such as production, operations, maintenance, safety, testing, process improvement or product development. For higher levels, may suggest and/or make improvements to optimize work processes.

Autonomy: Established and productive individual contributor, working under moderate supervision. Performs tests, interprets results and perform lot release. Organizational Impact: Performs intermediate technical activities requiring judgment and decision-making. Work consists of technical tasks that are typically routine. Innovation and Complexity: Technical problems faced are generally routine, but may require interpretation of procedures or policies to resolve problems. May be required to highlight areas of concerns/problems in own job area. Communication and Influence: Communicates typically with internal contacts. Obtains and provides technical information requiring some explanation or interpretation. Leadership and Talent Management: May provide guidance and assistance to new or entry level employees.

Required Knowledge and Experience:
Requires basic job knowledge of systems, techniques and procedures obtained through prior work experience or education. Requires minimum of 2 years of relevant experience; may require vocational or technical education or certification in addition to prior work experience.

25-35 pay rate range
**salary will be commensurate with experience**

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