Quality Manager - Medical Device - Hudson, MA

This Quality Manager role requires ensuring cGMP and ISO 13485 compliance, managing quality systems, handling regulatory processes such as CAPA and recalls, and securing successful audits. The position also encompasses continuous improvement initiatives, data analysis, team leadership, and supplier quality management to assure the dependability and uniformity of medical devices.

Client Details

This company develops and markets advanced retinal imaging technology, primarily known for its ultra-widefield imaging devices. Their innovative solutions provide eye care professionals with comprehensive views of the retina, aiding in the early detection and management of ocular diseases.

Description

• Ensuring regulatory and quality system compliance (cGMP, ISO 13485).
• Managing key regulatory processes (complaints, MDR, CAPA, recalls, audits).
• Maintaining product and quality documentation (DMR, labeling, training).
• Driving continuous improvement through data analysis.
• Supervising staff and managing supplier quality.

Profile

• Strong knowledge of cGMP and ISO 13485 regulations and their practical application in a medical device setting.
• Proven experience in managing quality systems, handling regulatory submissions, and leading successful audits.
• Excellent analytical and problem-solving skills with a data-driven approach to continuous improvement.
• Effective leadership and communication abilities to manage teams and collaborate across departments.
• A proactive and detail-oriented approach with a commitment to maintaining high quality standards.

Job Offer

• Focus on quality and regulatory compliance.
• Collaborative teamwork.
• Continuous improvement mindset.
• Potential for professional growth.
• Comprehensive health and retirement plans.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.