Job Description

Job Description

The following is not intended to represent an all inclusive list of job responsibilities, but to outline the ESSENCIAL FUNCTIONS of the position.

Basic Function:

* Under direct supervision performs a substantial variety of moderately complex to highly complex inspection tasks using standard procedures, gauges, tools, computers and equipment.

Responsibilities:

* Continuously fully comply with all ISO, FDA regulations and QSR and other quality standard requirements,
* Perform inspections of manufacturing processes of Injection Molded components and process raw materials.
* Ensure in process, and/or finished components meet company and regulatory standards.
* Participates in training others on inspection techniques and procedures.
* Work from engineering prints, task instruction or quality inspection procedures to perform accurate checks and tests.
* Comply with documentation and regulatory procedures and policies.
* Interact with engineers, supervisors and non-exempt / exempt personnel, to resolve in process products issues.
* Work from written and/or verbal directions/instructions.
* Assess compliance of processes to standards established.
* Assist in developing and using standard inspection procedures.
* Participate in or lead QA improvement projects, audits.
* Generate and investigate non-conformance reports under the supervision of the Quality Engineers.
* Ensure proper use of inspection routines for measuring components.
* Inspect components through validated measuring routines on OGP optical measuring system.
* Inspect calibration certificates, labeling and literature to ensure regulatory compliance.
* Verify periodically ECA parameters to ensure room compliance to procedure environmental controls.

Supervisory Responsibilities:

* N/A

Physical Requirements:

* Medium Work: Exerting up to 50 pounds of force occasionally and/or up to 20 pounds of force constantly to move objects.
* Very good visual acuity.
* Ability to work with and inspect very small objects and/or tools and component parts.

Mental Requirements:

* Observe and note minute inconsistencies.
* Follow and explain detailed instructions and inspections procedures.
* Explain detailed documentation accurately.
* Communicate product and/or component part deficiencies to supervisory or engineering personnel.
* Prioritize work effectively.
* Identify routine product issues using independent judgment and inspection equipment.
* Address problems independently based on limited information.

Required Skills:

* Read, write, and speak English.
* Math and measurement skills.
* Ability to select and operate appropriate measurement equipment accurately.
* Procedures/engineering drawings reading and interpretation.
* Routine inspection techniques.
* Basic Computer Skills

Required Experience:

* 6-12 months experience in manufacturing processes for medical devices or other regulated environment such as ISO, FDA, and Pharmaceutical etc.
* At least 2 years close tolerance quality inspection.

Required Education and Training:

* High School Diploma.
* Quality/Mechanical skills recognition desired.