Quality Inspector
Our facility in Lake Zurich is looking for an experienced Quality Inspector to come in and make a quick impact on our Medical Device production team. This is a 2nd Shift role, from 3PM to 11PM, Monday to Friday with little OT. Please see below for further detail:
Position Summary |
The Quality Inspector I position performs component and product inspection in the quality department in support of the department objectives to provide goods and services that meet customer’s requirements for quality, quantity and timeliness. The position’s responsibilities pertain to confirming a part’s or product’s physical attributes meet a customer’s or internal specification.
Duties and Responsibilities |
· Follow companies Quality system, including all applicable SOP's included in the Training Matrix
· Affirm incoming materials meet purchase order specifications
· Prepare station for inspection, including organization and cleaning of station
· Audit samples of in-process components, sub-assemblies, and final product to ensure they meet customer specifications, provide documentation support
· Perform first article inspections and prepare appropriate reports
· Completely and accurately fill in LHRs or forms in support of manufacturing, maintain documents in accordance with Quality Manual and all applicable work instructions
· Inform supervisor and/or Production Line Supervisor of issues or unanticipated non-conformances.
· Advise supervisor in the event of needed tool or equipment repairs.
· Awareness of impact of action to quality of product (defect awareness). Identify defects and communicate defects to supervisor and/or engineer for the product through use of the reject log or direct communication.
· Identify defects and communicate these defects to the Production Line Supervisor, responsible engineer, and/or quality representative
- Perform Lot release testing with assistance (e.g. engineer, higher level inspector, etc.)
· Maintain good working relationships with peers and co-workers
· Maintain identification of materials, tools and procedures as the device is inspected
· Work overtime as required
· Perform line clearance audits
· Performs other duties as assigned
Education |
- Vocational - High School Diploma or equivalent experience
Experience |
- I - 5 years inspection experience (medical device experience preferred)
- Computer experience and proficiency required to support business system tracking and data entry
Skills, Knowledge and Abilities |
· Ability to fluently read, write, verbally communicate, and follow directions in English
· Ability to work an entire shift under a microscope
· Ability to work an entire shift in a clean room environment including but not limited to:
o Temperatures ranging from 68°F to 80°F
o Relative Humidity ranges below 35%
o Wearing of appropriate clean room gowns, head/foot/hair coverings, non-latex rubber gloves for an entire work shift
· Ability to organize and coordinate work efficiently. Complete tasks and assignments as assigned by Management and Sr. peer group
· Skilled in writing procedures, reports and data entry
· Ability to read/interpret engineering drawings
· Good hand to eye coordination and manual dexterity
· Able to work on a computer and familiar with Microsoft Office (Word and Excel) and Adobe programs (PDF's)
· Knowledgeable on the use of Metrology measurement tools (calipers, micrometers, vision measurement systems, inspection microscopes and similar measurement instrumentation). Able to effectively use tools and equipment as assigned.
· Have and demonstrate good judgment
· Maintains confidential information, in accordance with Company policy
· Training
o Must be able to be trained on and retain the knowledge needed to effectively perform QA tasks
Physical Demands of Position |
The physical demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee sits, stands, uses hands, arms and fingers to perform routine tasks in inspection, packaging and cleaning. Normal vision and hearing are needed, and the ability to communicate effectively to others in person or via written communication. This position will primarily work in a production-controlled environment room (CER), but also required to work in the final packaging and warehouse environment. This position has occasional lifting of 25 lbs. This is not an exhaustive list of responsibilities, skills, duties, requirements, or working conditions associated with this job. While this list is intended to be an accurate reflection of the position, the company reserves the right to revise the functions and duties of the job or to increase or decrease the scope of responsibilities when circumstances dictate, as determined by management.
Measurement of Performance |