JOB DESCRIPTION
North American Rescue, LLC
Job Title: Quality Inspector
Department: QA/RA
Reports to: Quality Manager
FLSA Status: Non-Exempt
SUMMARY
Participates as a TEAM member within the QA/RA Department. This NAR Associate works closely to ensure that all incoming inspection activities and Device History Record (DHR) kit assembly documentation is completed accurately, and that all product is released as appropriate. Primary function is to complete quality control and inspection activities, including incoming inspection activities, final QC inspection, and DHR final review and batch release.
ESSENTIAL RESPONSIBILITIES
This is not an all-inclusive list of duties and responsibilities. Projects/duties may be modified/changed/added/deleted as needed.
- Know/understand NAR Products, as directed; their quality requirements (specifications/tolerances/lot control, etc.)
- Know/understand NAR Product "direct packaging" requirements, such as those that must be vacuum packed, and non-vacuum packed
- Know/understand the related/necessary assembly processing requirements that NAR Products must undergo
- Conduct incoming inspection activities, including inspecting product, following sampling plans and applicable work instructions, notifying QA/RA of any nonconformities or necessary updates to inspection criteria, release conforming product
- Conduct final QC inspection activities, including inspecting product, following sampling plans and applicable work instructions, notifying QA/RA of any nonconformities or necessary updates to inspection criteria, release conforming
- Review DHRs for accuracy and proper completion; consult with the originator to correct any inaccuracies; ultimately, sign and release all completed and conforming DHRs
- Report all identified non-conformances and document them on the non-conformance log
- Cooperate/take direction/support Quality Manager and the QA/RA department; and all executive management personnel, as a means to support internal/external "Stakeholders"
SUPPLEMENTAL RESPONSIBILITIES
- Completes any other duties and/ or projects assigned by the supervisor
- Demonstrate capability and become cross-trained to provide strong assistance for NAR
- "Other" support work as identified by the Operations and Regulatory Management
AUTHORITY
- After review of NAR Quality System documents, such as NAR DHRs and MOs, and upon any discrepancy findings is empowered to seek and obtain appropriate corrections from subject document initiator(s)
- Empowered to conduct incoming inspection activities and identify nonconformities or potential nonconformities
- Empowered to conduct final review and batch release of DHRs
- Empowered to report any potential nonconformities, and conduct investigation into root cause of any nonconformities
QUALIFICATIONS
Education
- Graduation from High School and/or Trade School is required.
- One (1) year experience working in quality, warehouse, and distribution environment is preferred.
- Previous forklift/materials handling experience is preferred.
- Demonstrated knowledge and basic experience of ability to use company software system(s), such as GP/MS-Dynamics and MS-Excel spreadsheet creation and interpretation is preferred; job shop/production schedule execution experience is required.
Competency and Skills
- Consistently applies appropriate communication skills; both oral and written
- Strong quality orientation, attention to detail, personal desire to meet/exceed requirements
- Ability to identify and resolve problems
- Ability to manage multiple priorities
- Ability to work with limited direction and supervision
- Builds and maintains effective working relationships
- Ability to change direction and focus
- Ability to learn/utilize company business system software and MS-Office Products
- Ability to learn/become a trained "trainer" in all applicable NAR Quality System requirements, and related: FDA compliance requirements, ISO-13485 they are applied locally
DEMANDS
Time and Availability
- Personal tasks are completed in both office and operational environments
- Ability to use a computer including visual acuity and hand-eye coordination
- Ability to perform standard body movements:
- Frequent sitting at desk and using computer keyboard
- Occasional bending, squatting, stooping and reaching
- Ability to tolerate moderate office noise levels
- Ability to tolerate moderate operational /warehouse floor noise levels
Travel
- Must have reliable transportation to and from NAR, LLC 35 Tedwall Ct.
Physical
The physical demands described here are representative of those that must be met by a typical office employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Ability to lift 50+ pounds on an occasional basis
Environment
- Ability to tolerate warehouse and assembly operations noise
- Ability to work in a confined area and in a warehouse environment
DISCLAIMERS
- AAP/EEO Statement
North American Rescue provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law. Further, the company takes affirmative action to ensure that applicants are employed, and employees are treated during employment without regard to any of these characteristics. Discrimination of any type will not be tolerated.
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