As a member of the Quality and Regulatory group, the Quality Inspector will work in accordance with FDA and international regulations. The Quality Inspector shall verity that the material and documentation received from suppliers are in compliance with SpineFrontier specification requirements. Additionally, this position is responsible for maintaining lot history records, participating in the material review board (MRB), and processing non-conforming material reports (where appropriate). As a member of the Quality team, the inspector will participate in the ongoing improvement and maintenance of SpineFrontier’s Quality Management System. Secondary functions of this role include working with the Supply Chain department on shipping and receiving activities, as required.
To perform this role successfully, the candidate must be able to fulfill each duty and responsibility satisfactorily; training will be provided as needed.
- Coordinate with Supply Chain and Engineering departments on inspection priorities
- Initiate NCMRs and participate in MRB meetings for material disposition
- Review inspection forms and MPIs per product design changes
- Assist in archival activities for lot history records (LHRs), including scanning and compilation
- Receive incoming material: verify the part number, lot number and quantity of parts being received, and transact the receipts in the ERP system
- Perform technical inspections on parts returned from the field, as required
- Label material, as required
- Effectively follow policies, procedures, and work instructions
- Assist in the maintenance and updating of QMS documentation related to subject matter area(s).
Inspect all incoming product through verification (visual and functional) using the appropriate inspection tools and inspection methodology
- Interpret and review FAIs, certifications, label reconciliations and other records for accuracy
- Identify device non-conformalities
- Support shipping and receiving:
- Pick and pack product for shipment according to standard operating procedures.
- Ensure orders are fulfilled with the correct product, quantity, revisions, and lot numbers.
- Must be able to read, write and communicate fluently in English.
- The employee in this position often communicates with employees and vendors who have inquiries, therefore must be able to read, write and communicate to exchange correct information in these situations
- Competency in inspection methodology and equipment usage
- Critical thinking skills
- Attention to detail
- Familiarity with quality management systems and regulations
To perform this job successfully, the candidate must be able to perform each essential duty satisfactorily; training will be provided as needed. 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.
The successful candidate will be required to possess:
- High school diploma or GED
- 0-2+ 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 applications
- Understanding of sampling plans and AQLs, 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
- CQI preferred
- This employee is required to sit for extended periods of time using a computer keyboard and monitor
- Position routinely requires filing, which will require opening file cabinet drawers, being able to bend for file placement.
- The position often needs objects be moved from one place to another under 15 pounds lifting periodically must move objects.
- The employee in this position often communicates with employees and vendors who have inquiries, therefore must be able to read, write and communicate to exchange correct information in these situations.
- Worker must have the visual acuity to determine the accuracy, neatness, and thoroughness of the work assigned.
- The employee is required to have close visual acuity to inspect products perform, analyze data and numbers, view a computer terminal; extensive reading at a distance that is close to the eyes.
- This position operates in a clerical setting and routinely uses standard equipment, telephones, photocopiers, filing cabinets etc.
- Employee may be required to travel up to 10% of the time
Please no outside unsolicited recruiters