Massachusetts Jobs

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 preferred

• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint)

• Strong knowledge of ISO 13485, 21 CFR 820, and other Quality Management System standards

• Experience with internal auditing or formal auditor training

• Detail-oriented and highly accurate

• Ability to apply basic mathematical concepts such as percentages, ratios, and proportions in practical situations

• Strong collaboration skills to work across teams and with external consultants

• Ownership mentality with the ability to take the initiative on assignments and proactively seek guidance when needed

Additional Information:

• No third-party resumes will be accepted

• Drug testing and/or other employment-related inquiries may be conducted

• CTG will consider qualified applicants with criminal histories, consistent with applicable 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 Krista.Eckard@ctg.com .

About CTG

CTG, a Cegeka company, is at the forefront of digital transformation, providing IT and business solutions that accelerate project momentum and deliver desired value. Over nearly 60 years, we have earned a reputation as a faster and more reliable, results-driven partner. Our vision is to be an indispensable partner to our clients and the preferred career destination for digital and technology experts. CTG leverages the expertise of over 9,000 team members in 19 countries to provide innovative solutions. Together, we operate across the Americas, Europe, and India, working in close cooperation with over 3,000 clients in many of today's highest-growth industries. For more information, visit www.ctg.com .

Our culture is a direct result of the people who work at CTG, the values we hold, and the actions we take. In other words, our people define our culture. It's a living, breathing thing that is renewed every day through the ways we engage with each other, our clients, and our communities. Part of our mission is to cultivate a workplace that attracts and develops the best people, reflected by our recognition as a Great Place to Work Certified™ company across many of our global operations.

CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws.

CTG is an Equal Opportunity and Affirmative Action Employer. CTG will assure equal opportunity and consideration to all applicants and employees in recruitment, selection, placement, training, benefits, compensation, promotion, transfer, and release of individuals without regard to race, creed, religion, color, national origin, sex, sexual orientation, gender identity and gender expression, age, disability, marital or veteran status, citizenship status, or any other discriminatory factors as required by law. Our Affirmative Action program serves to promote occupational equality and diversity through good faith efforts. CTG is fully committed to promoting employment opportunities for members of protected classes.