Quality Control Inspector
Astura Medical
Summary
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.
Job description
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.
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.
Requirements
- 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
- Experience with vision systems (preferred)
- Experience with SOLIDWORKS Inspection (preferred)
- Medical device or aerospace inspection experience (preferred)
- Experience working under ISO 13485, AS9100, or FDA-regulated quality systems (preferred)
Benefits
- Medical, Dental & Vision
- Short-term Disability
- Life Insurance
- Paid Vacation
- Sick Leave
- Inclement Weather Pay
- 401(k) Matching
Company overview
Astura Medical is a medical device company specializing in the development and manufacturing of innovative spinal surgery solutions. The company focuses on creating advanced orthopedic implants and surgical instrumentation designed to improve patient outcomes in spinal procedures. Astura Medical operates within the highly specialized field of spine surgery, developing products that address complex spinal conditions and degenerative disorders. The company's product portfolio likely includes spinal fusion systems, interbody devices, and related surgical tools that support minimally invasive surgical techniques. As a medical equipment manufacturer, Astura Medical contributes to the advancement of spinal care by providing surgeons with reliable, high-quality devices that enhance surgical precision and patient recovery. The company operates at the intersection of medical technology and orthopedic innovation, serving healthcare providers and patients in need of sophisticated spinal treatment options.