SMC Ltd ยท 1 month ago
Quality Analyst I - 1st shift M-F 8hrs
Devens, MA, US
Full-time
Onsite
Senior Level
$26.99/hr - $26.99/hr
6+ years expSMC Ltd. is a globally recognized premium supplier to the medical market, seeking dedicated individuals for their team. The Quality Analyst I will work independently with minimal guidance, supporting various quality processes and ensuring compliance with ISO 13485 standards.
ManufacturingMedical Device
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
Qualification
Required
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
Preferred
Working knowledge of ISO, FDA, GMP, and OSHA standards preferred
Benefits
This is a long-term contract opportunity with benefits
Company
SMC Ltd
SMC Ltd. offers global solutions, contract manufacturing and molding services for the medical device, diagnostics, and pharmaceutical industries.
501-1000 employees
H1B Sponsorship
SMC Ltd has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2022 (1)
Funding
Current Stage
Late StageLeadership Team
Carlos Castro
Talent Acquisition Partner
Jeff Burke
Human Resource Partner
Company data provided by crunchbase