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Quality Inspector III, 2nd

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KARL STORZ

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Location:
United States , Charlton

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

22.00 - 28.00 USD / Hour
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Job Description:

Responsible for verification of purchased and in-house manufactured products to ensure conformance to process and product requirements. Such verification can include inspection, test and audit functions or some combination thereof.

Job Responsibility:

  • Verification of purchased and in-house manufactured products to ensure conformance to process and product requirements
  • Perform moderately difficult inspection and functional test of components, sub-assemblies and finished devices in accordance with established procedures
  • Familiar with required documentation (blueprints, procedures and test/inspection plans)
  • Understand and direct focus to priorities within the inspection department, with little or no supervision. Able to act as a team lead as required
  • Understand, teach, support and lead by example lean principles
  • Understand, teach, support and lead by example 6S principles
  • Perform audits as necessary for the job function
  • Cross trained in all areas of inspection, including incoming inspection, Fiberscope Final Inspection, and Videoscope Final QC Inspection
  • Perform training in the aforementioned areas, to procedures and SAP transactions, as required
  • Perform calibrations and preventive maintenance activities for equipment assigned to the QA department
  • Maintenance of inspection logs, worksheets and device history records
  • Perform material transactions and other SAP transactions as required. Assist in trouble shooting activities, as related to department transactions and cycle counts
  • Perform final labeling and packaging of Finished Goods
  • Perform data entry of QC Inspection results using Excel and SAP
  • Ensure Good Documentation Practice of all controlled records
  • Perform archiving activities for digital storage of controlled records
  • Accountable for final release of product to shipment
  • Review of quality and repair records and review and maintenance of inspection and device history records
  • Coordination of and participation in MRB activities
  • Able to perform off-site inspection activities, as required

Requirements:

  • High school graduate or equivalent
  • 3 – 5 years’ experience in Quality Control or in a manufacturing role where quality is essential to the product
  • Ability to read and interpret engineering drawings, procedures and sampling plans
  • Knowledgeable in the Lean process
  • Ability to lead in both 6S and CI (EOED) efforts
  • Proficient in various inspection techniques, including visual inspection (using a microscope), performing variable and attribute mechanical/dimensional measurements, optics inspection and electronic/safety testing desired
  • Knowledgeable of fiber and video endoscopes and can make pass/fail decisions independently
  • Knowledgeable in the FDA and ISO Quality Systems requirements
  • Previous experience with medical devices and QSR/ISO requirements desirable
  • Process time at or below takt time consistently
  • Experience with computer data entry
  • Experience completing various ERP transactions such as SAP
  • Certified Shift Trainer preferred
  • Must be able to work overtime as needed
  • Must be punctual, able to sustain attendance guidelines, and work hours as assigned
  • Regular and predictable attendance and proper notification/communication in the event of absence or tardiness
  • Moderate lifting of objects up to 50lbs. Lifting up to 70lbs. (with assistance) may be required on occasion
  • Some inspection functions may require standing for extended periods of time
  • Some inspection functions may require viewing under microscope for long periods of time
  • Visual acuity of 20/25 in the better eye with or without correction
  • Capable of making accept/reject decisions based on both established procedural criteria and subjective criteria and of explaining these decisions to other inspection personnel or other contacts
  • Able to communicate, in both written and verbal format, clearly and concisely with personnel at all levels of the organization
  • Must be able to recognize and bring to supervisory attention, situations that may impact quality, but which are not covered in established procedures
  • Must be capable of making suggestions to aid in the solution of various workflow situations and process improvements
  • The ability to recognize and bring to supervisory attention near miss and ergonomic issues that may impact the department or company as a whole
  • Must be committed to a high standard of safety and be willing and able to comply with all environmental and safety laws and regulations
  • Must be willing to report actual and potential environmental and safety violations to appropriate supervisory and/or management personnel
  • Must not pose a direct threat or significant risk of substantial harm to the safety of himself/herself or others
  • Responsible for informing the Company if he/she is taking medications or if there are any other circumstances that would interfere with safe performance of job duties
  • Must be able to maintain productive working relationships with co-workers
  • Must treat fellow employees with respect
  • Able to escalate atypical non-conformances to management
  • Must be adaptable and demonstrate flexibility in dealing with changing priorities and work situations

Nice to have:

  • Previous experience with medical devices and QSR/ISO requirements desirable
  • Certified Shift Trainer preferred
What we offer:
  • Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance
  • 3 weeks vacation, 11 holidays plus paid sick time
  • Up to 8 weeks of 100% paid company parental leave
  • includes maternal/ paternal leave, adoption, and fostering of a child
  • 401(k) retirement savings plan providing a match of 60% of the employee’s first 6% contribution (up to IRS limits)
  • Section 125 Flexible Spending Accounts
  • Life, STD, LTD & LTC Insurance
  • Tuition pre-imbursement up to $5,250 per year
  • Fitness reimbursement of up to $200 annually

Additional Information:

Job Posted:
February 14, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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