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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)