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Quality Control Inspector

3 months ago

Lexington, United States Integrated Resources, Inc ( IRI ) Full time

Job Title: QC Inspector

Location: Lexington, MA

Duration: 12 Months

Notes: First or second shift, flexible on that, BUT training happens first shift 7-3 for the first 2 months.

Must Haves

  • Mechanical tester experience.
  • Instron or MTS, gage experience.
  • Nice to have Med Device
  • To provide technical testing and evaluations current products and support for process and product validations.
  • Perform physical and visual inspection on finished goods and incoming raw materials used in the production of products according to released test methods.

Essential Duties and Position Responsibilities:

  • Perform final physical/visual inspection of all finished products.
  • Inspect, sample, and perform physical/visual tests on package components and raw materials according to released Standard Operating Procedures.
  • On time approval of raw materials, sub-assemblies and finished products.
  • Coordinate with other departments to prioritize inspections as appropriate.
  • Verify calibrations and maintenance are performed on department equipment at time of use
  • Set up and operate routine experiments and testing using the appropriate related equipment with minimal supervision.
  • Set up and operate routine experiments for process validation and product verification using approved protocols and methods.
  • Instrumentation set up with pressure transducers, flow meters, chart recorders, meters, tensile testers and precision dimensional measurement equipment.
  • Support and assist in the development of lean thinking programs and participate in the implementation of these programs throughout the facility as required
  • Maintain a good attendance and on-time record as outlined in the Attendance Guidelines for our facility
  • Use of Good Documentation Practices Daily.
  • Assist Quality Engineering with process and product validation testing
  • The ability to work overtime
  • Initiate NCMRs as required.
  • Other duties as assigned
  • Must be available for Overtime if required.

Qualifications, Knowledge, and Skills Required:

  • High School diploma or GED required
  • One or more years of experience working in a medical device or other regulated industry
  • Mechanical inspection experience (Tensile testing, peel testing, Instron or MTS equipment or equivalent) required
  • Duties require knowledge of cleanroom gowning and work environment.
  • Must have ability to read, write, interpret, comprehend, and consistently follow specifications written in English
  • Computer literacy particularly with databases and spreadsheets / basic ability to use Microsoft Office required
  • Duties require basic knowledge of math
  • Duties require knowledge of inspection/sampling techniques and familiarity with ANSI/ASQZ1.4, ISO-9000 and ISO13485.
  • Duties require basic knowledge of mechanical and physical inspection techniques. (Calipers, micrometers, blueprint/artwork reading, etc.)
  • Basic understanding of Good Manufacturing Practices (GMP) and Quality System Regulations (QSR)