Quality Control (QC) Technician

LifeLens Technologies, Inc. is a medical device developer located in beautiful Bucks County, PA. We are pioneering innovative, next-generation treatment devices for personal health monitoring. 

We are hiring a Quality Control (QC) Technician. In this role, you are responsible for the testing and evaluation of finished devices, printed circuit board assemblies (PCBAs), mechanical and electronic sub-assemblies. Duties will also include reviewing electronic and paper records associated with the processing, inspection, and testing of finished devices and executing Quality Assurance release of product that conforms to specified requirements including Good Documentation Practices (GDP). You play an essential role in product testing, acceptance, and defect tracking. 

This is a full-time, on-site position.

Responsibilities:

• Conduct quality inspections and testing throughout the production process, including incoming, in process and final inspections.


• Inspect PCBAs for defects, including solder quality and visual damage.

• Confirm all documentation including production and quality records supporting product release fully adheres to acceptance criteria and good Documentation Practices (GDP) including data integrity. Escalate any discrepancies immediately.


• Maintain, monitor, and manage the batch record management system, including closure and disposition, data collection, and archiving of the records.


• Log data from batch records into the quality metrics database. Generate reports on manufacturing yields and defects for management and engineering staff.

Education and Training:

• Associate’s degree in a science or technical field, or HS diploma with applicable work experience.


• Direct experience and knowledge of Good Documentation Practices (GDP)


• Knowledge of quality management systems and regulatory compliance requirements FDA Quality System Regulation ISO 13485 is preferred.


• Strong organizational and attention to detail skills.

 Experience:

• Minimum of 2 years of experience in a QA or QC role in medical device manufacturing or related industry.  Manufacturing Quality Record review experience is strongly preferred.

• Experience using a variety of measurement tools, including multimeters, calipers and micrometers.


• Experience with PCB assembly and/ or electronics manufacturing

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).


• Excellent communication and interpersonal skills.


• Ability to work independently and manage multiple priorities

Physical Demands:

• Able to use standard office equipment (computer, mouse, keyboard, printer, etc.)

• Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and the ability to adjust and focus.


• Must be able to lift 30 lbs.

Benefits:

• Health Insurance


• Dental & Vision Insurance


• Stock Options


• Paid Time Off


• Flextime