Quality Assurance Team Leader (Medtech)

TL;DR

Quality Assurance Team Leader (Medtech): Supervising a team of QA technicians to ensure product safety and compliance within a medical device environment with an accent on complaint handling and failure analysis. Focus on maintaining procedural requirements, performing root cause analysis, and coordinating departmental activities to meet quality standards.

Location: Must be based in Chelmsford, MA

Salary: $30.00–$45.00 per hour

Company

hirify.global Corporation is a global leader in acute care technology, dedicated to developing innovative lifesaving products and software solutions for cardiopulmonary and respiratory conditions.

What you will do

• Supervise and coach a team of Quality Assurance Technicians.
• Review and close product complaints and document investigation results.
• Perform root cause analysis on defective units, subassemblies, and accessories.
• Coordinate failure analysis with vendors and external laboratories.
• Propose corrective actions and report on unresolved problems to leadership.
• Conduct work group meetings and ensure adherence to production and quality schedules.

Requirements

• Knowledge of FDA QSR and quality tools in a medical device environment.
• Experience with ESD handling and electro-mechanical assembly methods.
• Proficiency in MS Windows and MS Office suite (Excel, Access, PowerPoint, Word).
• Ability to direct, coach, and train associates effectively.
• Experience with mechanical and electronic test equipment.
• Must be authorized to work in the United States.

Nice to have

• Associate's Degree.
• Knowledge of Vigilance, Canadian, and other international regulations.
• 4-6 years of relevant experience.

Culture & Benefits

• Comprehensive benefits plans including health and wellness coverage.
• Opportunity to work on lifesaving medical technology.
• Collaborative and innovative work environment.
• Commitment to professional growth and career development.