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Senior Quality Technician
4 months ago
Exciting opportunity for a Senior Quality Technician to work with a growing biotechnology company focused on cancer screening and detection.
Primary responsibilities include completing required document reviews and material inspections, completing associated forms and other documents as part of Standard Operating Procedures and Work Instructions process requirements, in compliance with the EU In Vitro Diagnostic Regulation (IVDR), ISO 13485, ISO 14971, FDA 21 CFR 820 and related medical device regulations.
This individual is responsible for executing acceptance activities associated with receiving inspection and release of purchased items, and finished product inspection of internally manufactured items. These items (i.e., components, raw materials, and finished reagents) are processed in accordance with our medical device and clinical laboratory quality management system requirements. This person works closely with Supply Chain, Manufacturing Science & Technology (MSAT), Quality Control (QC), Development, Design Quality, and other teams to ensure compliance with procedures and product quality assurance is maintained. The person in this role consistently applies critical thinking skills and good judgment to solve focused problems.
Schedule/Shift: 1st shift, Mon.-Fri. 7:00/8:00am-4:00/5:00pm
Position Type: Contract-to-hire role
Essential Duties and Responsibilities:
- Conduct quality inspections on incoming items, in-process production items, and finished products to ensure compliance with quality standards and specifications.
- Collaborate with production teams and Quality Engineering teams to improve quality inspection procedures and processes.
- Utilize quality systems and tools to track, analyze, and report on quality metrics.
- Initiate and drive to completion thorough and correct nonconformance reports when quality issues are identified.
- Coordinate with Supplier Quality and Supply Chain to resolve issues identified in quality inspection activities.
- Support Quality Engineers in the conduct of root cause analysis and associated activities to address quality issues.
Qualifications:
- High school diploma or GED required. Bachelor's degree (BS) in relevant science or engineering field preferred.
- Five (5) years of experience working within medical device or pharmaceutical quality management systems (QMS), optimally with direct responsibilities for performing receiving inspection, in-process inspection, and finished product inspection.
- Experience conducting quality inspections using various measurement tools and equipment, as well as reviewing paper and/or electronic documents and records including specifications, certificates of analysis, certificates of compliance, quality control test results, and device history records in compliance with standard operating procedures and work instructions.
- Working knowledge and implementation of applicable medical device regulations and standards including but not limited to 21 CFR 820, ISO 13485, ISO 14971, MDR / IVDR.
- Demonstrated expertise initiating and completing nonconformance reports and providing guidance and oversight to ensure appropriate segregation, identification, and ultimate material disposition (physical and electronic).
- Experience working with software applications such as Enterprise Resource Planning (ERP), Laboratory Information Management Systems (LIMS), electronic quality management systems (eQMS), document management systems, and related tools.
- Ability to analyze data and generate reports to communicate quality trends and issues.
- Strong written and verbal communication skills.
- Ability to comprehend and interpret technical information related to analytical methods, processes, and regulatory requirements
Preferred Skills and Experience:
- Leadership or supervisory experience in receiving inspection and internal acceptance activities.
- ASQ Certified Quality Technician, Certified Quality Engineer, or similar.
