Quality Technician

Quality Technician

The Quality Technician supports the design, development, and manufacture of advanced hemostat and wound healing technologies by performing hands-on quality activities in a collaborative, team-based environment. This role works closely with Operations, Quality, and Engineering teams, focusing approximately 25% of the time on receiving inspection and 75% on broader quality functions such as QMS documentation, CAPA support, and validation activities. The position is ideal for a self-motivated individual who enjoys working in a small, growing organization and is eager to expand their skills and responsibilities.

Responsibilities

• Perform receiving inspection of incoming raw materials using appropriate measurement tools and documentation practices.
• Prepare engineering and test samples to support product and process development activities.
• Record test results accurately and compare them against defined acceptance criteria, escalating issues when needed.
• Print and verify finished product labeling to ensure accuracy and compliance with requirements.
• Review and approve Product Lot Folders to confirm completeness, accuracy, and compliance with quality standards.
• Support equipment installation and qualification activities, including documentation and verification steps.
• Assist in the development of internal and supplier-based quality plans to improve product and process quality.
• Maintain and update Quality Management System (QMS) documentation in accordance with established procedures.
• Support Corrective and Preventive Action (CAPA) activities by gathering data, documenting findings, and assisting in implementation and verification of actions.
• Collaborate daily with Quality Engineering and other cross-functional teams to resolve quality issues and improve processes.
• Use micrometers, calipers, and other measurement tools to perform precise inspections and measurements.
• Manage multiple tasks and priorities in a dynamic environment, taking initiative and working with minimal supervision.

Essential Skills

• 2+ years of experience working in a Quality Technician role, preferably within the medical device industry.
• Hands-on experience performing receiving inspections of materials and components.
• Proficiency using micrometers, calipers, and other measurement tools for precise inspections.
• Strong documentation skills with the ability to record, organize, and maintain accurate quality records.
• Experience working within a Quality Management System (QMS) environment.
• Familiarity with CAPA (Corrective and Preventive Action) processes and supporting activities.
• Ability to support validation and qualification activities for equipment and processes.
• Self-starter mentality with the ability to take initiative and manage multiple responsibilities.
• Strong collaboration skills and comfort working closely with engineers and cross-functional teams.

Additional Skills & Qualifications

• Preferred 2-year degree in a technical, scientific, or related field.
• Experience in the medical device industry, particularly in a manufacturing or quality environment.
• Ability to wear multiple hats and adapt to changing priorities in a growing organization.
• Comfort working in a smaller company setting with a lean management structure.
• Interest in expanding skills in QMS documentation, CAPA, validation, and quality planning.
• Ability to contribute to internal and supplier-based quality plan development.

Work Environment

The role is based in a small, growing company of roughly 60 people within a midsized organization that is expanding through acquisition. The culture emphasizes collaboration, self-motivation, and close daily interaction with engineers and cross-functional teams. The work environment is business casual and supports individuals who take initiative and enjoy learning new skills. Typical hours are approximately 8:00 a.m. to 4:30 or 5:00 p.m. The company offers 120 hours per year of accrued paid time off, additional state safe and sick time, and 8 paid holidays.

The setting involves working with quality and measurement tools, supporting production and engineering activities, and engaging in both office-based documentation work and hands-on…