Quality Inspector II

Our facility in Lake Zurich is looking for an experienced Quality Inspector II 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:

The Quality Inspector II 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.

·         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.

·         Identify and evaluate best means and methods by which to perform the inspection.

·         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 minimal 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

• Applicable Associates or Bachelors Degree (Preferred), Quality Training and/or Certification preferred (ANSI/ASQ, Six Sigma)

• Minimum 2 years of applicable inspection experience (medical device experience preferred)
• Computer experience and proficiency required to support business system tracking and data entry

·         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.

·         Able to complete tasks and assignments as assigned by Management and Sr. peer group in a timely manner

·         Able to manage own workload and understand amount of time necessary to complete a task or assignment

·         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 Metrology tool and/or equipment as assigned

·         Demonstrate ability to distinguish the best metrology tool and/or equipment to use for a task or assignment      

·         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

o    Should be able to self-train on routine and similar skilled tasks

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 is 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.

1.     Completion of quality inspections and tasks accurately, on time and on budget

2.     Complete all reports (NCR’s, first article inspections, inspection forms, etc.) accurately and on time

3.     Uses appropriate metrology instruments to acquire accurate part/product inspection results

4.     Follow written procedures

5.     Maintains positive relationships with peers, supervisors and all internal and external customers and suppliers