NextPhase Medical Devices LLC is a fast-growing, engineering design and contract manufacturer of single-use and electromechanical medical devices, with facilities in Rochester, NH, Mansfield, MA, and Tijuana, Mexico.
Based in our Mansfield, MA facility, the role of the Quality Control Technician is to perform and ensure the product documentation is complete, accurate and compliant to the ISO 13485 standards and FDA regulations.
Essential Duties and Responsibilities:
- Understand, support, and comply with the Company Quality System requirements.
- Maintain a safe and clean work environment.
- Follow the standard operating procedures and written work instructions.
- Openly communicate with the Company team members.
- Perform Device History Record (DHR) review for production and RGA products.
- Perform label inspection on product labeling.
- Generate product Certificate of Conformance (C of C) documents for production and RGA.
- Perform final acceptance of product before customer shipment
- Review sterilization process data and reports for compliance.
- Identify and support continuous improvement efforts with Supervisor.
- Take on special projects as assigned.
- Other duties as assigned.
Other Duties:
- Verifies work affecting quality independently and has the authority to perform these tasks as stated in the responsibilities section.
- Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Required Qualifications and Work Experience:
- 3-5 years in a regulated manufacturing environment, experience in an ISO 13485:2016 manufacturing environment is preferred.
- Strong mechanical aptitude abilities.
- Ability to communicate effectively through oral and written communications.
- Ability to work with others collaboratively.
- Attention to detail to understand and meet the requirements.
- Strong organizational skills.
- Strong verbal communication skills.
- Demonstrated problem-solving ability in a cross-functional environment.
- Take responsibility for task and time management.
Physical Demands:
This position requires working in an office setting. This includes sitting at a desk working on a computer
for long periods of time. It also could include lifting 40 pounds and standing for long periods of
time as well as walking the facility.
Attendance:
- This position necessitates full-time on-site presence