Position Scope/Summary
This position is necessary to provide accurate and timely movement of product through the facility. The ability to verify correct and legible marking on product, support quality with basic inspection, and ensure proper and timely shipments to our Customers is required.
Key Result Accountabilities
•Manufacturing Support
oIn-process inspection as required.
oInspect vendor supplied components / assemblies. Assist suppliers in duplicating our inspection techniques and meeting our product specifications.
oLaser inspection.
oUse most gaging methods in the facility, including roundness checker, profilometer, and height stands.
•Final Product Release
oDocument any discrepancies in accordance with BRIM-WI-13-01 Control of Non-Conforming Material; insure that parts are properly labeled and quarantined to prevent shipment
oCertify documentation (i.e.: Certification, first article data, process capability study, etc.) prior to shipment against C of C (provided in traveler packet)
oVerify packaging matches specified requirements (where indicated) or is adequate if no specific requirements exist
oVerify customer purchase order requirements (provided in traveler packet)
oVerify/ sign completed MSC-10.01 shipment verification review form
•Continuous Improvement
oComplies with work rules including safety, health, quality system, and Accellent Quality Management Systems
oAssist in investigating and preventing customer complaints
oWork with customers and suppliers to implement corrective and preventive actions
oWhen asked, serve as a member of Continuous Improvement teams
Environmental Working Conditions
Employee must comply with all safety policies and safe work procedures established by the company.
Job tasks may also involve:
•Using personal protective equipment such as safety glasses, goggles, gloves, and other equipment as established in company policies and safe work procedures
•Working near cutting & machining fluids, solvents, lubricants and other hazardous chemicals using appropriate safety controls
•Lifting up to 50 pounds
•Frequent carrying, bending, standing, sitting, and repetitive motion
Employee will be expected to attend safety training, serve on the facility safety committee, if asked, and participate in hazard analysis and resolution.
Qualifications
•High school diploma or GED, plus 3 years experience in Quality and/or Operations
•Some college and / or 1 year equivalent experience in similar regulated field, Medical Device experience preferred
•Experience with MS-Word, Excel, Access, and Power Point for word processing and documentation support
•Good communication skills
•Must be able to complete prioritized tasks with minimal direct supervision while maintaining focus on preventive activities
•Complete all job specific required training
•Ability to understand and comply with the FDA’s Quality Systems Regulations (QSR) and ISO 13485:2003 standards
Please submit resume to
Accellent
Attn: Christian Svejk
68 Mill Lane Road
Brimfield, Mass 01010
or submit electronically to
christian.svejk@accellent.com
or
craig.swanson@accellent.com