Quality Control Technician (Temp Position)
- Identify solutions and/or complete assigned tasks related to the resolution of corrective and preventive actions, internal audit findings, and non-conformance reports.
- Ensure QC work areas are maintained and organized.
- Oversee quarantine cage and disposition materials as required.
- Enforce controlled environment policies and procedures.
- Ensure that finished devices consistently meet required quality standards based on documented requirements.
- Support incoming inspection activities as needed.
- 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.
- Review device history records for good documentation and completeness to ensure compliance with procedural and regulatory requirements prior to the release of finished goods.
- Document and communicate results of acceptance activities per approved and applicable quality system procedures, forms, and/or other documents.
- Support calibration activities as assigned.
- And all other duties as assigned.
- 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.
- Ability to maintain punctual attendance.
- Comprehensive knowledge in interpreting blueprint reading and interpretation.
- Ability to maintain accurate records.
- Communicate effectively by conveying facts and information clearly both verbally and orally.
- Strong organizational skills and attention to detail.
- Ability to work independently and to carry out assignments to completion within parameters of instructions given prescribed routines, and standard accepted practices.
- Associate’s degree, technical training/certifications or equivalent.
- One to three years’ quality inspection in a manufacturing environment or equivalent.
- One – three years of experience in a controlled manufacturing environment preferred.
- General knowledge in regulatory requirements including the FDA quality system regulations and ISO 13485.
- Basic Computer skills, i.e., Word and Excel.
- The working environment is indoors and is seasonally heated and cooled with minimal noise levels.
- The position requires considerable standing and the ability to move objects of less than 25 pounds.
- The position requires the ability to communicate in person, telephonically and via email.
- 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).
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