Job Description: 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.

Key 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 Lot History Records 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

Qualifications:

• 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

• Training

• Must be able to be trained on and retain the knowledge needed to effectively perform QA tasks

Benefits:

• Competitive pay rate and performance-based bonuses

• Comprehensive health, dental, and vision insurance

• Retirement savings plan with company match

• Paid time off and holidays

• Professional development and training opportunities