Job Description
Job Description
Overview
Come join us and grow your career with CTG! CTG has worked with this international, Fortune 500 end-client for over 15 years! Apply with CTG for this exciting opportunity!
CTG's premier client has a contract assignment for a Quality Management System Specialist.
Type : Contract
Job Title : Quality Management System Specialist
Location : Tewksbury, MA
Candidates must be able to commute and work onsite in Tewksbury, MA
Pay Rate : Based on experience
Work Hours : M-F 8am-5pm
Education : Bachelor’s or Master’s Degree
A successful candidate in this position will possess strong soft skills as well as :
- Excellent communication skills, both written and verbal
- Strong organizational and time management skills
- A proactive approach with the ability to work independently
- Strong attention to detail and problem-solving abilities
Description :
The Quality Management System Specialist will be responsible for ensuring that quality management system processes are effectively implemented and maintained, in compliance with applicable standards. The role involves performing change controls, managing quality management records, conducting internal audits, and supporting continuous improvement initiatives. The specialist will also assist with regulatory activities, analyze quality metrics, and support various quality projects.
Key responsibilities include :
Quality Documentation : Generate, review, and maintain division-level quality system documents such as procedures, work instructions, job aids, and certificates of conformity, ensuring compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.Change Controls : Initiate and manage Change Controls and Document Change Requests to update quality procedures and processes. Work with manufacturing and distribution teams to assess the impact of changes on site-level operations.Quality System Metrics : Assist in monitoring and assessing key quality system metrics to ensure ongoing compliance.Internal Audits : Lead internal audits for the division’s audit program to ensure conformity to internal quality management processes.CAPA Support : Assist in the completion of Corrective and Preventive Actions (CAPAs), utilizing root cause analysis techniques.Continuous Improvement : Support and lead continuous improvement initiatives for quality management system processes.Regulatory Activities : Assist in activities related to regulatory compliance.Requirements : Education :
Bachelor’s Degree with 3 years of relevant work experience (manufacturing environment preferred)Master’s Degree with 1 years of relevant work experience (manufacturing environment preferred)Qualifications :
Previous experience using ETQ software preferredProficiency in Microsoft Office Suite (Excel, Word, PowerPoint)Strong knowledge of ISO 13485, 21 CFR 820, and other Quality Management System standardsExperience with internal auditing or formal auditor trainingDetail-oriented and highly accurateAbility to apply basic mathematical concepts such as percentages, ratios, and proportions in practical situationsStrong collaboration skills to work across teams and with external consultantsOwnership mentality with the ability to take the initiative on assignments and proactively seek guidance when neededAdditional Information :
No third-party resumes will be acceptedDrug testing and / or other employment-related inquiries may be conductedCTG will consider qualified applicants with criminal histories, consistent with applicable lawsAll interested individuals MUST be able to work on a W2 Tax basis (no C2C or third-party vendors)CTG is an Equal Employment Opportunity employerCTG is an E-Verify CompanyTo be considered for this opportunity, please apply directly through our website by clicking the link below or email your Word version resume and salary expectations to Krista.Eckard@ctg.com .
