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Quality Technician II

Company: Planet Pharma
Location: Boulder
Posted on: January 13, 2022

Job Description:

20-30/h pay

Top skills needed: Medical device experience, technical writing skill

Identify and document appropriate complaint categories to assure trend accuracy within the complaint database.
Writes investigation summaries based on technical product analysis information provided
Ensures record documentation is maintained in a constant state of audit readiness per internal policies.
Review, evaluate, classify and perform follow up activities on all product complaints relative to the identity, quality, reliability, safety, and effectiveness of medical devices.
Interact with Technical Service, Manufacturing, R&D, and Quality Assurance, as needed, during the course of complaint processing.

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 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, checks, analysis and documentation of studies. Prepares and monitors quality statistics and reports. Reviews production records for conformance to procedures. Conducts non-conformance tests of manufactured, packaged or tested product.

TECHNICIAN SUPPORT CAREER STREAM: Provides technical support in areas such as production, operations, maintenance, safety, testing, process improvement or product development. Uses schematics, diagrams, written and verbal descriptions or defined plans to perform testing and troubleshooting on electronic or mechanical components, equipment or systems. Gathers, maintains, formats, compiles, and manipulates technical data using established formulae and procedures, and performs detailed mathematical calculations. For higher levels, may suggest and/or make improvements to optimize work processes.

Differentiating Factors

Autonomy: Established and productive individual contributor, working under moderate supervision. Performs tests, interprets data and develops reports.

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.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Keywords: Planet Pharma, Boulder , Quality Technician II, Professions , Boulder, Colorado

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