Quality Control Inspector

Description

Astura Medical is quality driven, surgeon-inspired, and innovative medical device company. We have a robust distribution channel combined with passion and innovation to drive our teams to achieve great success with developing medical devices and entering them into the spinal implant marketplace.

We're centrally located in Irving, TX, and we offer a collaborative work environment with casual dress and work-life balance.

What You Will Do

As a Quality Control Inspector, you’ll be the last line of defense between our manufacturing partners and the surgeons who rely on our implants and instruments. You’ll inspect parts against engineering drawings, document results accurately, and help keep nonconforming product out of the field. You’ll report to the Quality Control Manager.

Responsibilities

• Perform inspection of implants and surgical instruments against engineering drawings and specifications.
• Take precision dimensional measurements using calipers, micrometers, optical comparators, pin gauges, gauge blocks, and      other equipment, such as height gauges, or a vision system.
• Perform visual and cosmetic inspection using surface finish and color standards.
• Verify provided documentation aligns with drawing/assembly specs.
• Verify fit and function using hard gauges and functional fixtures/ mating parts where applicable.
• Record inspection results accurately and completely in SOLIDWORKS inspection.
• Identify and document nonconforming product and support the nonconformance process.
• Work within a quality system aligned with FDA 21 CFR Part 820 and ISO 13485 .

Pay Range: $23.00–$25.00 per hour, OT as required

Requirements

Qualifications

• 2+ years of hands-on inspection experience in a manufacturing environment.
• Strong skills with calipers, micrometers, pin gauges, gauge blocks, optical comparators, and vision systems a plus.
• Ability to read and interpret engineering drawings.
• Solid GD&T interpretation and understanding.
• Sharp attention to detail and organized work habits.
• Comfort with Microsoft Excel and Word.
• Clear written and spoken English.
• High School Diploma or equivalent

Nice to Have

• Experience with vision systems
• Experience with SOLIDWORKS Inspection
• Medical device or aerospace inspection experience
• Experience working under ISO 13485, AS9100, or FDA-regulated quality systems

Physical Requirements

In an office settings require prolonged sitting and standing, frequent hand-eye coordination for computer work, and manual dexterity for using tools. Physical demands include walking, bending, reaching, and lifting, typically up to 10–25 lbs.

What We Offer!

• 100% paid Benefits that include -- Medical, Dental, Vision, STD, and Life
• 10-days’ Vacation that increases each year employed
• 3-days Sick / 2-days Inclement Weather pay
• 401k matching up to 3%