Senior Quality Inspector

Our facility in Lake Zurich is looking for an experienced Senior Quality Inspector to come in and make a quick impact on our Medical Device production team. This is a 1st Shift role, from 6AM to 2PM, Monday to Friday with little OT. Please see below for further detail:

The Quality Inspector Senior 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

·         Identify applicable dimensions for the FAI – Prepare, format, and produce FAI sheets needed for inspections

·         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.

·         Generate NCR to address the Non-conformance

·         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

• Independently perform Lot Release testing, understanding the equipment required to perform the testing

·         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 Bachelors Degree (Preferred), some level of Quality Training and/or Certification (ANSI/ASQ, Six Sigma)

• Minimum 7 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

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

·         Able to effectively assign and manage workload of less senior QA personnel, as requested by QC management

·         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/or equipment as assigned

·         Demonstrated ability to distinguish the best tools and/or equipment to use for a task or assignment

·         Demonstrated ability to identify and recommend improved QA means and methods for a task or assignment

·         Be a subject matter point of reference for certain tools and equipment – especially computer-controlled QA devices

·         Demonstrated ability to train and mentor others on the best and proper use of Metrology tools

·         Ability to create and execute measurement programs on computer-controlled QA devices     

·         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 QC tasks

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

o    Demonstrated ability to train and certify proficiency on any task or assignment

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