Quality Manager

Overview

The Quality Manager, reporting to the Director of Quality Assurance & Regulatory Affairs, is responsible for leading and managing the development, implementation, maintenance, and evaluation of quality systems and processes in our MA and ME facilities. Oversees production and supplier quality management activities. Responsible for ensuring that quality practices comply with applicable standards, regulations, and procedures.

Please note that relocation assistance is not available for this position.

Principal Responsibilities

• Evaluate production operations to ensure that products meet quality, integrity, functionality, and other specifications and requirements.
• Ensure the effective use of QMS systems including CAPAs, customer complaints, NCRs/MRB, change management, training, supplier management, deviations, preventive maintenance, and calibration.
• Implement Quality Control objectives, metrics, KPIs, and reporting to monitor production quality and post-sale product performance and identify continuous improvement opportunities.
• Ensure departmental compliance with the QMS, FDA QSR, ISO13485, ISO9001, and other regulatory requirements.
• Prepare product and process quality reports by collecting, analyzing, and summarizing information and trends.
• Monitor supplier performance; evaluate and improve supplier auditing and monitoring processes.
• Oversee internal quality audits and develop corrective action plans to address findings; support external audits.
• Oversee documentation control activities & tools; ensure QC documentation such as checklists, logs, and reports are effective, and accurate.
• Participate in new product introduction and transfer to production activities, including providing feedback for continuous improvement.
• Foster a collaborative and high-performance quality culture based on continuous improvement principles to help improve quality, reduce costs, and increase customer satisfaction.
• Collaborate cross-functionally to develop training methods and training effectiveness.
• Ensure individual and team goals align with corporate strategic objectives.
• Perform miscellaneous duties and projects as assigned and required.

Working Conditions

This job operates in manufacturing and engineering laboratory environments including ISO class 7 cleanrooms. PPE required when in controlled environment rooms or cleanrooms.

Physical surroundings

This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets.

Physical Effort

While performing duties of this job, the employee is occasionally required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear.

Work Schedule / Travel

In-person, Mon to Fri in Gardner, MA; occasional travel, with periodic presence in the Windham, ME site.

Other Requirements

Applicants must have US citizenship or US person status.

Training, Skills, Knowledge and/or Experience

• 5 years of experience in quality management in process-oriented manufacturing operations in a regulated environment, with a minimum of 3 years in managing quality control/management.
• Minimum 2 years of experience in medical devices and FDA QSR and ISO 13485 required; prior defense/aerospace industry experience desired.
• Demonstrated experience in implementation and continuous improvement of the QMS to improve quality, reduce costs and improve efficiency.
• Lean and/or Six Sigma certification/experience highly preferred.
• Demonstrated experience in internal and external QMS audits; ISO 13485 Lead Auditor certification preferred.
• Experience building strong relationships with employees, customers, and suppliers.
• Proficiency with Microsoft 365 apps suite, and project management tools.

Competencies

• Solid understanding of quality management and engineering and related tools, FDA QSR, and ISO standards relating to regulation of medical devices.
• Strong data collection & analysis, problem solving, presentation and communication skills.
• Strong attention to detail, with excellent analytical, problem-solving, and project management skills.
• Excellent leadership and people skills, with the ability to identify/develop talent, and inspire others to achieve.
• Process improvement skills to simplify quality/business processes, tools, and workflows.

Education Requirements

Bachelor’s degree in Engineering or a related technical/science field; or an equivalent combination of education and experience.