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.

• 1 - 3 years' experience in Quality Control or Manufacturing

• Ability to read and interpret engineering drawings, procedures and sampling plans.

• Knowledgeable in various inspection techniques, including visual inspection (using a microscope), performing variable and attribute mechanical/dimensional measurements, optics inspection and electronic/safety testing and inspection desired.

• Previous experience with medical devices and QSR/ISO requirements desirable.

• Experience with computer data entry.

• Computer literacy and experience with in-house applications (Excel)

• Experience in SAP 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.

• Some inspection functions may require standing for extended periods of time.

• Some inspection functions may require viewing under microscope for long periods of time.

• Moderate lifting of objects up to 50lbs. Lifting up to 70lbs. (with assistance) may be required on occasion.

• 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.

2. MENTAL REQUIREMENTS

• Capable of making accept/reject decisions based on both established procedural criteria and subjective criteria.

• 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 able to recognize and bring to supervisory attention situations that may impact quality, but which are not covered in established procedures.

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.
• Able to understand and direct focus to priorities within the inspection department under supervision.
• Able to cross-train in two or more areas of inspection, including incoming inspection, Fiberscope Final QC inspection, and Videoscope Final QC inspection
• Perform preventive maintenance activities for equipment assigned to the QA department.
• Perform periodic audits for ESD compliance and report audit results.
• Maintenance of inspection logs, worksheets and device history records.
• Perform material transactions and other SAP transactions as required.
• 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.

• Participation in MRB activities.

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