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Senior, Quality Control Technician (Swing)

Ascent Services Group

Job Description

Senior, Quality Control Technician
Menlo Park, CA

PURPOSE OF JOB: Support quality assurance and adhere to QSR and ISO regulations.

MAJOR DUTIES AND RESPONSIBILITIES:
  • Perform inspections/ testing activities pertaining to IQC, in-process, final packaging inspection, product lot release, verification /validation testing activities, first article inspections (FAI), and product retain inspection.
  • Support day to day manufacturing activities.
  • Generate detailed and accurate inspection and testing reports according to Current Good Manufacturing Practices (cGMP) and maintain inspection and testing files.
  • Generate and assist in NCMR investigations as assigned.
  • Maintain IQC records, QC related logs and databases (e.g. IQC, NCMR).
  • Perform QA related data entry and generate reports as required.
  • Perform Sterile Load processing and review.
  • Process RGA product, as appropriate.
  • Assist Quality Engineers, Manufacturing Engineers and R&D Engineers in developing inspection/test procedures, test method validations, and gage studies as assigned.
  • Coordinate test requests and shipments to contract laboratories.
  • Implement improvements to inspection and test documentation, and Quality System procedures.
  • Assist in identifying continuous improvement opportunities.
  • Support company goals and objectives, policies and procedures, QSR, and FDA regulations
  • Audit production lines to ensure QSR/GMP compliance as assigned.
  • Perform Device History Records review and product release activities as assigned.
  • Perform other QA related activities as assigned.
  • Train new Quality Control Technicians

EDUCATION /EXPERIENCE REQUIREMENTS:
  • Associate degree or equivalent industry experience preferred.
  • Certified Quality Technician (CQT) or Certified Quality Improvement Associate (CQIA) preferred.
  • Minimum of 5 years of experience performing QA inspections/testing activities pertaining to IQA, in-process, lot release and V&V, and administration of various Quality Systems in the medical device industry.
  • The ability to understand and follow Quality System Procedures (e.g. SOP and Test Methods).
  • Strong understanding of, cGMP, QSR and ISO13485:2003 requirements.
  • Working knowledge in reading and interpreting technical specifications and mechanical drawings.
  • Strong knowledge of a wide variety of inspection and test equipment, and methodologies.
  • Experience with computer-based applications (MS Word, MS Access, MS Excel, ERP)

OTHER QUALIFICATIONS:
  • Excellent written and verbal communication skills.
  • Strong time management skills and the ability to multi-task in a fast-paced environment.
  • Excellent organizational skills.

Job Requirements

 
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Job Snapshot

Location US-CA-West Menlo Park
Employment Type Contractor
Pay Type Hour
Pay Rate N/A
Store Type Energy, Oil & Gas

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Terms & Conditions
Snapshot
Ascent Services Group
Company:
US-CA-West Menlo Park
Location:
Contractor
Employment Type:
Hour
Pay Type:
N/A
Pay Rate:
Energy, Oil & Gas
Store Type:

Job Description

Senior, Quality Control Technician
Menlo Park, CA

PURPOSE OF JOB: Support quality assurance and adhere to QSR and ISO regulations.

MAJOR DUTIES AND RESPONSIBILITIES:
  • Perform inspections/ testing activities pertaining to IQC, in-process, final packaging inspection, product lot release, verification /validation testing activities, first article inspections (FAI), and product retain inspection.
  • Support day to day manufacturing activities.
  • Generate detailed and accurate inspection and testing reports according to Current Good Manufacturing Practices (cGMP) and maintain inspection and testing files.
  • Generate and assist in NCMR investigations as assigned.
  • Maintain IQC records, QC related logs and databases (e.g. IQC, NCMR).
  • Perform QA related data entry and generate reports as required.
  • Perform Sterile Load processing and review.
  • Process RGA product, as appropriate.
  • Assist Quality Engineers, Manufacturing Engineers and R&D Engineers in developing inspection/test procedures, test method validations, and gage studies as assigned.
  • Coordinate test requests and shipments to contract laboratories.
  • Implement improvements to inspection and test documentation, and Quality System procedures.
  • Assist in identifying continuous improvement opportunities.
  • Support company goals and objectives, policies and procedures, QSR, and FDA regulations
  • Audit production lines to ensure QSR/GMP compliance as assigned.
  • Perform Device History Records review and product release activities as assigned.
  • Perform other QA related activities as assigned.
  • Train new Quality Control Technicians

EDUCATION /EXPERIENCE REQUIREMENTS:
  • Associate degree or equivalent industry experience preferred.
  • Certified Quality Technician (CQT) or Certified Quality Improvement Associate (CQIA) preferred.
  • Minimum of 5 years of experience performing QA inspections/testing activities pertaining to IQA, in-process, lot release and V&V, and administration of various Quality Systems in the medical device industry.
  • The ability to understand and follow Quality System Procedures (e.g. SOP and Test Methods).
  • Strong understanding of, cGMP, QSR and ISO13485:2003 requirements.
  • Working knowledge in reading and interpreting technical specifications and mechanical drawings.
  • Strong knowledge of a wide variety of inspection and test equipment, and methodologies.
  • Experience with computer-based applications (MS Word, MS Access, MS Excel, ERP)

OTHER QUALIFICATIONS:
  • Excellent written and verbal communication skills.
  • Strong time management skills and the ability to multi-task in a fast-paced environment.
  • Excellent organizational skills.

Job Requirements

 
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