Quality Specialist (Charlton/Franklin, MA)

Our Customer is an endoscope manufacturer, offering systems for human and veterinary medicine as well as for industrial applications. They are headquartered in El Segundo, California.

Our Customer is seeking a Quality Specialist on a contract basis to perform a range of Quality Engineering activities focused on driving continuous improvement across products and processes, as well as supporting new product and process development initiatives.

Key responsibilities include process validation, defect analysis and corrective action, new product evaluation, and conducting internal audits to verify compliance with ISO standards and FDA/QSR regulations. The role also supports personnel training initiatives and the development and implementation of enhanced test and measurement techniques.

The ideal candidate brings strong analytical skills, regulatory knowledge, and a proactive approach to quality improvement within a regulated environment.

Schedule & Location:

Monday–Friday, 8:00 AM–5:00 PM. This role is primarily onsite in Charlton, MA, with occasional coverage required at the Franklin, MA site as needed.

Responsibilities:

• Oversee quality systems, including nonconforming materials, audits, management review, external standards, and document management
• Identify quality issues and provide resolution support
• Review test protocols, process validation protocols, and associated reports
• Prepare and analyze quality data, metrics, and performance reports
• Support internal audits of systems, products, and processes
• Prepare for and support external and regulatory audits
• Prepare and process engineering changes
• Provide training and direction to manufacturing and quality assurance personnel
• Participate in Material Review Board (MRB) meetings
• Support nonconforming material disposition activities
• Maintain CAPA processes, including investigation support and corrective action ownership
• Support quality and manufacturing continuous improvement initiatives
• Apply current management tools and quality practices in daily operations
• Ensure adherence to FDA Quality System Regulations and ISO 13485 requirements
• Maintain compliance with ISO 14001 environmental policies and company procedures
• Comply with all environmental, health, and safety laws, regulations, and internal policies
• Report environmental and safety concerns to the appropriate leadership
• Support Quality Management activities across applicable company locations
• Maintain professional working relationships across departments and with external customers
• Prepare professional written reports and deliver presentations to various organizational levels

Skills and Qualifications:

• Bachelor of Science degree in a technical or engineering discipline
• Minimum of 3 years of experience in a manufacturing environment
• Experience in manufacturing, quality, or process engineering preferred
• Knowledge of ISO 13485 and FDA Quality System Regulations (QSR) required
• Strong computer skills, including Microsoft Excel, Word, and Minitab
• Ability to communicate effectively at all organizational levels, both verbally and in writing
• Strong analytical and problem-solving skills
• Ability to function independently with minimal supervision
• Ability to manage multiple changing priorities in a fast-paced environment
• Sound judgment in making business decisions related to manufacturing quality and economic impact
• Ability to sustain attendance guidelines and assigned work hours
• Sufficient visual capability to assess component and product quality
• Ability to travel and drive as required for business needs

Preferred Qualifications:

• Medical device industry experience
• Certified Quality Engineer (CQE) certification
• Knowledge of Six Sigma and Lean manufacturing principles
• Experience supporting regulatory audits and compliance initiatives

We offer a competitive salary range for this position. Most candidates who join our team are hired at the median of this range, ensuring fair and equitable compensation based on experience and qualifications.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.