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Job Description
Sr. Lab Technician - Physical Materials Testing or Sr. Quality Control Technician
- Perform destructive and non-destructive testing on raw material, in process and finished goods (e.g. Visual Inspection, Length, Seal width, Porosity, Instron Testing, Radial Burst, DSC, pH, water Entry).
- Assess priorities and adjust own schedule if needed.
- Train others on various test methods, procedures, and new policies.
- Perform special and standard testing for Engineering Studies and Validations.
- Attend team meetings and provide feedback to the team.
- Provide guidance on lab and product related issues to Study Coordinators when writing protocols.
- Perform process audits, quality assessments and investigations as needed. o Issue corrective action and follow up to assure action is taken within the granted timeline.
- Perform the sampling of materials
- Data entry, use Excel to record results into testing forms and use MS Word to create reports and create change requests in PDM, trouble shooting and track product in SAP.
- Perform release activities for accepted raw materials in SAP.
Job Requirements
- A High school diploma, or equivalent, is required. Associates or BS Degree in Science, Math, Business or related field is preferred.
- A minimum of 3 years of lab experience; FDA regulated environment preferred, medical device experience ideal.
- Experience in reviewing and handling FDA regulated paperwork required. Must demonstrate effective verbal and written communication.
- Prior Instron testing experience using an Instron machine required
- Experience with SAP or equivalent ERP (Enterprise Resource Planning) system is required
- Member of American Society for Quality (ASQ), Certified Quality Technician (CQT) or Certified Quality Auditor (CQA) is preferred.
- Basic Algebra and math skills and basic understanding of metric and English systems of measurement are required. Must be able to perform basic math in all units of measure and demonstrate ability to read and interpret documents such as procedures and protocols.
- General knowledge of ISO standards and Quality System Regulations, SAP and Information Mapping experience preferred.
- Prior experience with IR scan, DSC, spectrophotometer, or similar types of testing equipment is preferred.
- Must demonstrate ability to work independently and manage multiple tasks and priorities. High attention to detail is required.
- Must demonstrate ability to work effectively in a team setting, be flexible, and exhibit willingness to learn/ take on new tasks.
- Must demonstrate ability to identify issues, effectively problem solve, and propose solutions.
- Proficiency with Microsoft Office Products such as Excel and Word or equivalent software applications is preferred.
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