POSITION SUMMARY
The QA Technician Inspector I, works with limited supervision to conduct incoming, in-process, and final product
inspection; support the control and disposition of nonconforming materials and supplier corrective actions; calibrate
equipment; create, finalize and maintain quality records; process customer returns; and print product labels.
OriGen Biomedical is a global leader in cryopreservation and cell culture. We collaborate with top researchers,
clinicians and business partners to enhance solutions, improve patient outcomes, and achieve customer
satisfaction by providing safe and effective products that positively impact the quality of life.
Reporting directly to the QA Manager, this individual will interface daily with Manufacturing, Operations, Research
and Development, Customer Service, and Marketing in our corporate offices in Austin, TX.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The essential duties and responsibilities of this position include, but are not limited to the following:

• Performs inspections of incoming, in-process, and final product for conformance to quality assurance

standards using an approved sampling plan.

• Accurately completes all quality control documentation and inspection sheets in accordance with ISO

13485 Standard and established procedures.

• Verify inspection equipment, machinery and tools used are calibrated per company policy.
• Follows verbal and/or written instructions such as production traveler, work instruction, process

specifications, and drawings at the direction of supervisor in completing a variety of inspection tasks.

• Makes decisions as to the acceptable quality; determines reasons for rejection; completes required quality

records.

• Identify, initiate quarantine, report and document all nonconforming product.
• Bring problems/issues to attention of Management.
• Work efficiently to achieve targeted goals as set by the production schedule.
• Participates and/or assists with cross training activities, training of new hires and temporary staff.
• Follows set training program for position and ensures training requirements are up to date.
• Demonstrates safe work habits, maintain clean and safe work area.
• Performs other duties as assigned, to maintain efficiency throughout the company.
• Conducts equipment calibration activities, requiring a good understanding of current metrology practices

and use of measuring instruments.
COMPETENCIES

• Self-starter
• Close attention to detail
• Ability to perform product inspections, including understanding of drawing dimensions and tolerances.
• Understanding of the selection and use of sampling plans.
• Familiar with quality tools and procedures
• Creativity and curiosity
• Organizational and time management skills
• Good math, technical writing and computer skills.

MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, & ABILITIES)

• High school diploma
• 1 years’ experience working within a formalized FDA or ISO Quality System

PREFERRED EDUCATION AND EXPERIENCE

• Associate degree or professional certification
• 1 years’ experience within a medical device manufacturing environment

SHIFT:
This is a second shift position, hours are Monday-Thursday 2:15 PM to 12:45 AM