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 Systems Specialist .
Type : Contract
Job Title : Quality Management Systems Specialist
Location : Oneonta, NY
Candidates must be able to commute and work onsite in Oneonta, NY
Pay Rate : Based on experience
Work Hours : M-F 8am-5pm
Education : Associates or Bachelor’s Degree, 3 years of work equivalent experience (work in a manufacturing environment is preferred)
A successful candidate in this position will possess strong soft skills as well as :
- Excellent communication and teamwork abilities
- Strong problem-solving and analytical skills
- Attention to detail with the ability to follow procedures accurately
Description
This position is responsible for performing change controls, creating and updating quality management procedures, managing records, and performing internal audits in compliance with the Quality Management System. The role will assist with the analysis of data for quality management system metrics, regulatory activities, and support quality management system projects and tasks.
Key Responsibilities :
Generate, review, and maintain division-level quality system documents including procedures, work instructions, job aids, certificates of conformity, etc., in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.Initiate Change Controls and Document Change Requests to update procedures and processes. Collaborate with manufacturing and distribution sites to assess the impact of changes to site-level processes.Monitor and assess quality system metrics to ensure continued compliance.Act as a lead auditor for the division internal audit program.Assist in completing quality projects and perform root cause analysis to help with the completion of CAPAs (Corrective and Preventive Actions).Support or lead continuous improvement initiatives for quality management system processes.Assist with regulatory activities.Other duties as required.Requirements :
Education : Associates or Bachelor’s Degree, 3 years of work equivalent experience (work in a manufacturing environment is preferred).Skills / Experience :Previous experience using ETQ or other Document Management software is preferred.
Proficiency in Microsoft Office.Experience in ISO 9001 or other Quality System standards.Knowledge of ISO 13485 and 21 CFR 820 Quality Management Systems is highly preferred.Internal auditor experience and / or training.Must be detail-oriented and accurate in executing work.Ability to apply basic mathematical concepts such as percentages, ratios, and proportions to practical situations.Ability to work across matrix organizations and with external consultants.Must be able to take ownership of assignments and proactively consult other project team members and department representatives as needed.Additional Information :
No third-party resumes will be accepted.Drug testing and / or other employment-related inquiries may be conducted.CTG will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws.All interested individuals MUST be able to work on a W2 tax basis (no C2C or third-party vendors).CTG is an Equal Employment Opportunity employer.CTG is an E-Verify Company.To 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 Rebecca.Olan@ctg.com .
