Quality Inspector III, 2nd

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Job Function:
Supply Chain & Procurement

Location:

Charlton, MA, US, 01507

Work Flexibility:
Onsite (Office/ Production)

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.

• 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.

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.

B. 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…