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Quality Inspector II, Sterile Single Use

3 months ago

Bellingham Massachusetts, Norfolk County, MA, United States KARL STORZ Endoscopy - America Full time

I. POSITION SUMMARY


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.

II. MINIMUM KNOWLEDGE, EDUCATION AND SKILL 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.

III. ESSENTIAL FUNCTIONS

A. PHYSICAL REQUIREMENTS

  • 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 in order to make judgments on visual quality of optical and other devices.

  • Work environment ranges from typical room ambient conditions of temperature and humidity to typical warehouse conditions, with uncontrolled temperature and humidity.

  1. MENTAL REQUIREMENTS

  • 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 (other departments, engineers, etc.), as required.

  • 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.

C. DUTIES AND RESPONSIBILITIES (Other duties consistent with the general nature and focus of the position and/or the goals and objectives of the department may be assigned.)

  • All employees are expected to be knowledgeable about and follow the Company’s Equal Employment and Affirmative Action Policies, including policies on the rights of individuals with disabilities and harassment.
  • 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.

D. ENVIRONMENT, HEALTH AND SAFETY:

  • Must be committed to a high standard of safety and be willing and able to comply with all environmental and safety laws and regulations, including the Company’s environmental and safety policies and procedures. Must be willing to report actual and potential environmental and safety violations to appropriate supervisory and/or management personnel.

  • The incumbent in this position is responsible for knowledge of and adherence to environmental policies and company procedures as they relate to ISO 14001.

  • 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.

E. QUALITY

  • The incumbent in this position is responsible for knowledge of and adherence to the policies and procedures as they relate to the requirements of FDA Quality System Regulation, and ISO 13485.

F. INTERPERSONAL AND COMMUNICATION SKILLS

  • 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.

  • Able to communicate, in both written and verbal format, clearly and concisely with personnel at all levels of the organization and on occasion, with external customers and suppliers.

  • Must be adaptable and demonstrate flexibility in dealing with changing priorities and work situations.

IV. OTHER FUNCTIONS

A. OTHER DUTIES AND RESPONSIBILITIES (Other duties consistent with the general nature and focus of the position and/or the goals and objectives of the department may be assigned.)

  • 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.

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