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Quality Control

  • Ref: 283049
  • Type: Direct Hire
  • Location: Morristown, NJ
  • Industry: Medical Devices
  • Job Level: Experienced Non-Manager
  • Pay: Negotiable

Opportunity Description

Our client, a manufacturer of medical devices, is currently seeking a Quality Control Technician who will be responsible for the daily QC Lab functions, including testing of product, calibration of lab equipment, testing for raw materials and paperwork and process audits.

Job Duties

  • Plans and organizes priorities utilizing the Daily Priorities form.
  • Responsible for timely achievement of assigned tasks and efficient time management.
  • Performs and reports daily testing of product according to established methods and requirements related to raw materials test/inspection/approval/release, final release processes. Supports the in-process testing.
  • Manages the testing schedule to support timely deliveries of customer orders.
  • Actively participates in the Quality Control Daily Targets related to safety, quality, delivery and cost.
  • Evaluates test data to support production and engineering.
  • Monitor and report test status of various production runs to QC Manager, Manufacturing Manager, QC Supervisor, Technology, or Process Engineer.
  • Identifies out-of-specification materials, including placing product on hold, proper identification and segregation of nonconforming materials, initiating non-conforming material report (NCR) and participating in investigations.
  • Provides support to Engineering, IT and R&D including participation in product/process development trials, carrying out new types of raw material and product characterization/performance testing and use of experimental materials.
  • Maintains and performs necessary calibrations and re-qualification processes for lab instruments and equipment (ex: densitometers, thermocouples, thermometers, F200s, F100s, PRTs, probes, baths)
  • Performs trend analysis of data and makes recommendations for improvements.
  • Supports data collection activities by entering information into various databases and spreadsheets.
  • Supports/leads calibration program activities to ensure overall Quality Management Process (QMP) compliance.
  • Verifies completeness of quality related documentation.
  • Assists/performs internal and external audits.
  • Maintains and adheres to all company safety policies and procedures.
  • Maintains work area organization and documentation to satisfy ISO and GMP standards.
  • Maintains good communication and working relationships with all departments and effectively functions within a team environment.
  • Exhibits professional etiquette that exemplifies the values of the organization.
  • Applies risk-based thinking when evaluating processes performance results for improvement opportunities.
  • Drafts/executes change controls, CAPAs, CIs, validation test protocols and prepares required reports.
  • Assigned technicians act as a contingency approver for the QC managerial functions such as raw material and interim material (ie manufactured ink) approval and release.

Experience & Skills Required

  • Must have a High School Diploma or GED and two to four years related experience and/or training or a combination of equivalent education and experience.
  • Experience in an ISO or GMP environment is highly desirable.
  • Word processing, spreadsheet (Corel & Excel), e-mail software in a Windows environment; Statistical software (Minitab) a plus.
  • Excellent organizational skills.
  • Ability to work independently with little supervision.
  • Good communication skills, written and oral.
  • Ability to read and interpret data, including graphs, as they relate to test results.
  • Ability to collect pertinent data, establishes facts, draw conclusions and identify problems.