As a member of the Quality and Regulatory group, the Quality Inspector will work to ensure compliance with FDA and international regulations and will participate in the ongoing improvement and maintenance of SpineFrontier’s Quality Management System. The Quality Inspector shall verity that the material and documentation received from suppliers are in compliance with SpineFrontier documented requirements. Additionally, this position is responsible for maintaining device history records, participating in the material review board, and managing non-conforming material reports (where appropriate). This is an opportunity for a quality professional to apply their knowledge and clearly see the benefits realized from their individual contribution.
Duties and Responsibilities
- Inspect all incoming product through examination (visual and functional) of the product final assembly and component’s critical features using the appropriate inspection tools and inspection methodology
- Interpret and review FAIs, certifications, label reconciliations, and other device history records for accuracy
- Help manage archival activities for device history records for lots inspected
- Coordinate with the supply chain, engineering, and quality departments on inspection priorities
- Write NCMRs and manage rejected material until a disposition is determined
- Reports are communicated verbally and in writing to material review board members
- Review inspection forms and MPIs as needed per product design changes
- Assist in the maintenance and updating of QMS documentation
- Effectively follow policies, procedures, and work instructions
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions, or to train technically-competent individuals in company specific software.
- High school diploma
- 5+ years of experience in Quality Inspection, preferably in medical devices or bio/pharma
- Ability to interpret instructions and mechanical drawings/part prints to effectively inspect product
- Comprehensive knowledge of inspection equipment and their applications
- Statistical understanding of AQL levels and ability to work in both English and metric units
- Working knowledge of ISO 13485 and 21 CFR 820 QSR
- Excellent communication and organizational skills
- Demonstrated ability to work collaboratively, follow instructions/schedules/timelines and handle multiple priorities with attention to detail
- Competency in Microsoft Office Suite
Work is generally performed within an office environment, with standard office equipment available. Travel up to 10%.
Must be able to read, write and communicate fluently in English.
How to Apply
Interested candidates, please submit your resume and cover letter to email@example.com