Quality Analyst I - 1st shift M-F 8hrs

SMC Ltd.•Devens, MA

About The Position

SMC, Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people. This is a long-term contract opportunity with benefits

Requirements

High school diploma or equivalent experience.
Minimum 6 years of Quality experience in the plastics industry, clean room/medical device assembly.
Knowledge and practical understanding of various assembly Inspection methods and inspection equipment.
Attention to detail and ability to manage multiple tasks and priorities.
Excellent interpersonal and communication skills
Proficient PC skills in a windows environment, Microsoft Word and Excel.
Ability to read, write and communicate in English.

Nice To Haves

Working knowledge of ISO, FDA, GMP, and OSHA standards preferred.

Responsibilities

Works Independent with minimal technical guidance, relies on experience and judgement to plan and accomplish goals.
Ability to coach, mentor and train others on all jobs within the department
Works with Engineering, Production and Quality to complete the Batch process
Redlining /relabeling activities through an ECO process
May assist with NPD (New Product Development) launch
attend Pre-PQ (Performance Qualification) meetings as required
Supporting ISO 13485 system requirements
Maintain gaging calibration cycles working with all departments. This includes generating GNR/ANR/PO/IRF and certifications.
Maintain Tailgate samples and delivery to warehouse for shipment
Assisting Quality Inspectors to ensure they have all tools necessary to perform their daily tasks
May perform internal audits per ISO Internal Audit Schedule
May cover Quality Inspector role as needed
May be required to monitor pressure/temperature monitors
Maintain a clean, neat, and organized working area with the help of the QA inspectors
Supporting an investigation for any Quality failures and improvements
Regular attendance, punctuality and professionalism
Other duties as assigned