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Department: Inspection (650)
Reports To: Manager – Regulatory Affairs/Quality Assurance
FLSA Status: Non-exempt

Summary: Under minimal supervision, the Inspector level II-MRB Specialist will, in accordance with ISO 13485 and FDA 21 CFR 820 Good Manufacturing Practices established operating procedures; perform the following essential duties and responsibilities:

Essential Duties and Responsibilities include the following:

1. Nonconforming Material: Either directly or through others, ensure the identification, traceability and control of rejected material and is able to accurately classify the origination of the defect.

2. Bonded Material: Maintain the security of nonconforming material under bond, whether inside or outside the Bond Room. (this does not include customer/government owned or returned material)

3. MRB Dispositions: Implement official Material Review Board (MRB) Dispositions including Scrap, Repair, Rework, RTV and UAI decisions. This will include follow up, problem resolution and coordination of disposition to obtain closure.

4. Quality Control Software: Manage nonconforming material and implement MRB Dispositions using the Epicor Discrepant Material Reporting (DMR) Nonconforming Material Control Module and corrective preventive action Module.

5. Mechanical Inspection: must be able to set up and accurately inspect machined parts using standard inspection devices including optical comparators.

6. Inspection Activities: must be able to perform all tasks related to Receiving, In-Process and Final Inspection for parts, components, assemblies, weldments, wiring harnesses, etc.

7. Quality Control Records: will file and maintain inspection related documents, records and reports related to inspection activities either in hard copy or electronic form.

8. Effectiveness: Must be able to multi-task with the ability to respond to changing priorities as required.

9. Other duties as assigned:

Supervisory Responsibilities

This job has no supervisory responsibilities.

Competencies

To perform the job successfully, an individual should demonstrate the following competencies:

Dependability / Attendance Decision Quality Delivers Results
Fast Paced Customer Focus Teamwork
Accuracy Managing Vision/Purpose Develops People Capability
Detail Oriented Values and Ethics Technical Skills
Safety & Security Action-Oriented

Qualifications

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.

Education and/or Experience

Associate's degree (A. A.) or equivalent from two-year College or technical school; and/or 3-5 years’ related experience and/or training; or equivalent combination of education and experience. Quality assurance duties performed in accordance with FDA 21 CFR 820 Good Manufacturing Practices and ISO 13485 preferred.

Other Qualifications

ASQ Certified Mechanical Inspector Certificate and ISO 9001 experience is a definite plus.

Language Skills

The employee must have the ability to read, write and comprehend simple instructions, data recording, correspondence, and memos.

Mathematical Skills

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.

Reasoning Ability

Must be able to demonstrate problem solving capabilities to carry out detailed written or oral instructions. Ability to deal with problems involving minimal variables in standard situations.

Computer Skills

To perform this job successfully, an individual must have experience with basic computer programs including: E-mail, MS Word and MS Excel including experience with databases and enterprise resource planning (ERP) systems. Preferred ERP system knowledge of Epicor (Vantage), SAP, Oracle, etc.

Physical Demands The physical demands described here are representative of those that must be met by an 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.

While performing the duties of this position, the employee is regularly required to sit or stand as well as freely move about the facility. The employee must be able use hands and fingers, handle or feel, talk and hear. The employee must be able to lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision and ability to adjust focus.

Work Environment The work environment characteristics described here are representative of those conditions an employee encounters while performing the essential functions of this job.

The noise level in the work environment is usually moderate. Temperature is ambient conditions.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions