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 Quality Electronics Technician III is to perform and ensure that quality production and service activities are completed to meet the customer delivery schedules while upholding the highest possible level of Quality. The Quality Electronics Technician III will inspect, test, and troubleshoot the medical device products using assembly fixtures, work instructions, procedures, and other equipment or documentation to ensure product specification compliance. The Quality Electronics Technician III will manage the production and RGA workflow to meet the customer commitment dates. This position reports to the Director of Quality Assurance.
Qualifications:
- 7+ years in a regulated manufacturing environment, experience in an ISO 13485:2016 manufacturing environment is preferred. A certificate or Associates in an applicable field of study or relevant experience is also preferred.
- Assembly, inspecting, testing, verifying, troubleshooting, and repairing environment
- Related PCBA and electro-mechanical experience, or equivalent combination of education and experience.
- Ability to read and interpret documents such as mechanical drawings, part drawings, schematic diagrams, work instructions, bills of materials, and procedure manuals
- Familiar with test equipment including but not limited to an oscilloscope, frequency generator, power supplies, multi-meters, flow meter, pull tester, and microscope
- Strong mechanical and electrical 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
- Experience with working to time standards
Essential Functions:
- Maintain a safe and clean work environment
- Follow the standard operating procedures and written work instructions
- Execute the daily production and service test, inspection, and troubleshooting priorities
- Collect and record process data in the Quality Management System
- Perform the preventive maintenance requirements on the identified test equipment as required
- Perform failure investigations and summarize the findings
- Review, train, and certify quality technician team members; on-the-job training records
- Provide leadership and mentoring to the quality team to achieve their goals & objectives
- Recognize, suggest, and lead continuous improvement ideas and cost reduction projects using Lean Six Sigma principles
- Identify and communicate document change requests when issues are identified
- Document any identified nonconformances and complete the corresponding documentation
- Take on special projects as assigned
- Other duties as assigned
Other Responsibilities Include:
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. The duties, responsibilities, and activities may change at any time with or without notice.
On-site/Remote Attendance:
This position requires 100% on-site attendance
Physical Requirements:
- Full range of motion for wrist, hand, and finger dexterity
- Ability to frequently sit, stand, walk, stoop, kneel, and crouch
- Ability to regularly lift/push/carry on average 30 pounds and at times up to 45 pounds
- Ability to use a microscope and/or magnifier lamp for visual inspection and evaluation
- Ability to see up close and from a distance for visual inspection and evaluation