Overview
Quality Analyst I Jobs in Devens, MA at SMC Ltd.
Full Job Description
About Us:
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.
Job Summary:
Develops and implements processes and procedures meant to improve quality throughout the organization.
Essential Job Duties and 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
Essential Qualifications:
High school diploma or equivalent experience.
Minimum 4 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.
Working knowledge of ISO, FDA, GMP, and OSHA standards preferred.
Ability to read, write and communicate in English.
ADA Requirements:
Stand, walk, bend, squat, twist, reach or otherwise move frequently
Occasional repetitive motion and grasping
Occasional climbing to reach areas on machines or racks
Lift, move or otherwise transfer up to 50 lbs. occasionally, >20 lbs. frequently
Typically sits, grasps items or performs keyboarding for occasional operation of a computer
Exposure to typical machine shop physical hazards which may require respiratory protection
At SMC Ltd. we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process.
SMC Ltd. is an equal opportunity employer. M/F/D/V; this organization uses E-Verify.
Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.
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Title: Quality Analyst I
Company: SMC Ltd.
Location: Devens, MA
Category:
