Senior Supervisor, Quality Control - Incoming Mechanical Inspection

Werfen-posted 12 days ago
$100,000 - $125,000/Yr
Full-time • Mid Level
San Diego, CA
5,001-10,000 employees
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The Senior Incoming QC Lab Supervisor is responsible for overseeing all QC activities related to verification of requirements of incoming, in process, finished good materials, ensuring compliance with company procedures, work instructions and inspection plans and directing the QC staff as required to execute all required tasks. The Senior Incoming QC Lab Supervisor is also responsible for staff training and resource utilization. They should have a dvanced knowledge of mechanical inspections, processes, equipment, GD&T, and blueprint reading. The salary range for this position is currently $10 0,000 - $ 125,000 annually. Individual compensation is based on the candidate’s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget, and/or other business and organizational needs.

  • Experience with receiving inspections.
  • M echanical inspections, processes, equipment, GD&T, and blueprint reading.
  • Ability to develop complex QC inspection methods.
  • Superior QC technical skills.
  • Experience working with measuring tools such as calipers, micrometers, or height and dial gauges.
  • Experience with vision systems such as micro-VU or keyence.
  • Ability to lead and guide staff to ensure compliance with the company quality management system.
  • Lead cross-functional efforts to resolve product performance issues and lead corrective actions to update Standard Operating Procedures (SOP) and training materials.
  • Support the Material Review Board in the execution of approved dispositions of NCR material.
  • Ensure department staff are technically capable and appropriately trained to their assigned inspection responsibilities.
  • Manage QC production deadlines and schedules.
  • Lead assigned CAPAs to successful completion.
  • Creation of QC validation protocols and reports.
  • Other duties as assigned.
  • Bachelor’s degree or equivalent combination of education and experience required.
  • A minimum of twelve (12) years progressive Quality experience within a Good Manufacturing Practice (GMP) QC lab setting required.
  • A minimum of two (2) years previous supervisory experience required
  • Previous Quality Assurance experience within a 21 CFR Part 820 and ISO 13485 regulated environment required.
  • Strong written, verbal and presentation skills are required.
  • Strong planning, organizational and time management skills..
  • Ability to appropriately prioritize department duties including urgent matters.
  • Demonstrated competence with interpreting requirements and applying standard quality control practices and methodologies to determine material acceptability.
  • Clear understanding of ISO 13485, Good Manufacturing Practices (GMP) & Good Documentation Practices (GDP).
  • The ability to train and mentor staff in complex inspection/verification methodologies.
  • Strong understanding of process, gage and equipment validation requirements.
  • Experience with Enterprise Resource Planning (ERP) system (such as SAP) preferred.
  • Computer literacy required; good working knowledge of Microsoft Office programs required.
  • Previous experience within a regulated medical device manufacturing or In-Vitro Diagnostic Device (IVDD) strongly preferred.
  • Experience with Enterprise Resource Planning (ERP) system (such as SAP) preferred.
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