QA Inspector (MEDICAL DEVICE)

Aptyx•Charlotte, NC

3d•Onsite

About The Position

Quality Inspector I Position: Quality Inspector I Location: Charlotte, NC Department: Quality Reports to: Quality Assurance Supervisor Company Overview: At Aptyx, a new name backed by 70 years of expertise, we bring together the aptitude and excellence of more than a dozen companies with decades of experience helping customers in the life sciences and other demanding industries solve complex manufacturing problems with confidence so they can create more good things in the world. We are committed to delivering high-quality products and services to our customers worldwide. We are seeking a talented Quality Technician to join our dynamic team and contribute to our mission of excellence and innovation. Job 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.

Requirements

Vocational - High School Diploma or equivalent experience
2-5 years 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 cleanroom environment including but not limited to: Temperatures ranging from 68°F to 80°F Relative Humidity ranges below 35% Wearing appropriate cleanroom 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 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
Must be able to be trained on and retain the knowledge needed to effectively perform QA tasks

Nice To Haves

medical device experience preferred

Responsibilities

Follow Aptyx Quality system, including all applicable SOP's included in the Training Matrix
Verify that 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 L ot H istory R ecord s 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 the impact of action on quality of products (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.)
Support basic tasks for equipment maintenance and CER validation activities as required by management
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