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, Waldwick, NJ, and Tijuana, Mexico.
Based in our Mansfield, MA facility, the Senior Quality Control Technician will work with other NextPhase personnel to maintain a corporate quality system. They will be responsible for product
inspection and/or audits of quality control programs. This candidate will also provide input and guidance to engineering department personnel regarding the completion of the nonconformance reports, product dispositions, and documentation of findings, as appropriate.
Other Responsibilities include:
- Assist with processing nonconformance report processing, including investigation for resolution.
- Expedite nonconformance evaluation and disposition.
- Conduct in-process and incoming inspections to approved procedures.
- Interpret manufacturing drawings, diagrams, and specifications to approve or reject units or
- Review device history records and complete sterilization reports, as applicable, per approved
- Responsible for the coordination and reporting of Quality Metrics including Nonconformance,
CAPAs, and other systems identified by management.
Skills & Experience Required:
- 5+ years in medical device quality assurance or related fields.
- Working knowledge of FDA Quality System and ISO-13485.
- Must be motivated and able to work well unsupervised.