Quality Assurance Specialist

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. 

As the Quality Assurance Specialist, you will primarily support CAPA management. You’ll conduct quality-related activities to deliver consistent, high-quality documents, services; products, and processes in the Quality team. In this role, you will create and manage nonconformance records, document nonconformance outcomes, complete root cause investigations, and document all aspects of the CAPA process.

The ideal candidate for this role is a detail-oriented problem solver.  Your passion and drive will be rewarded with a competitive salary, benefits, and long-term growth opportunities. 

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

Job Responsibilities:

• Facilitate CAPA and NCR investigations and coordinate investigation documentation.
• Support supplier quality and Customer assessment activities.
• Track and trend site Quality data.
• Support Customer complaint investigations and complete complaint documentation.
• Risk Management - Applies basic Risk Management principles to work.
• Ensures compliant documentation related to area of responsibility.
• Receives general direction and exercises considerable discretion to own work detail. Recommends possible solutions. Provides compliant solutions to a variety of complex problems.
• Ensures compliant documentation, carrying out tasks related to area of responsibility with management oversight.
• Implements tactical solutions related to assignment.

Job Requirements:

• Bachelor’s Degree in a related discipline (e.g. Engineering, Physical or Life Science)
• 2 years of experience working in Quality in a regulated industry (FDA, ISO 13485)
• Strong customer focus and teamwork orientation.
• Must be results-oriented with attention to detail.
• Continuous improvement focus.
• Ability to analyze technical issues.
• Ability to cope with change and shifting priorities.
• Must have strong written and verbal communication skills.
• Experience with MS Office applications including Word and Excel.

Physical Demands

• Able to use standard office equipment (computer, mouse, keyboard, printer, etc.)
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust and focus.
• Excellent fine motor skills are required. 

Work Hours

• Non-Exempt Position; Shift 8 a.m. to 4:30 pm M-F. Some Saturdays may be required
• Minimum of 40-45 hours per week, or other agreed-upon documented schedule

Benefits:

• Health Insurance
• Dental & Vision Insurance
• Paid Time Off