Senior Quality Engineering Technician
New Hartford, NY - USA
Department:
Job Summary
Overview
Resonetics is a global leader in advanced engineering prototyping product development and micro manufacturing driving innovation in the medical device industry. With rapid expansion across all our locations we continue to push the boundaries of technology while fostering a dynamic employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.
The Senior Quality Engineering Technician provides advanced customer- and factory-facing quality support for contract manufacturing of medical device components. This role serves as a key technical resource in the transition validation and sustaining of Nitinol manufacturing processes with increased ownership of quality systems data-driven decision-making and cross-functional support. The Senior Quality Engineering Technician operates with a high degree of independence and is expected to lead routine quality activities mentor junior technicians and operations personnel and drive improvements aligned with ISO 9001 ISO 13485 and 21 CFR 820 requirements.
Join Resonetics and be part of a team thats redefining medical device manufacturing. If youre passionate about innovation and thrive in a fast-paced environment wed love to hear from you.
Responsibilities
- Own and drive timely processing of Nonconformances Process Deviations and other quality records
- Maintaining calibration program
- Maintaining control plans/pFMEAs
- React to leading indicators in facilitation of preventive action execution
- Support document control activities
- Support Gage R&R completion and Test Method Validations
- Support Corrective and Preventive Actions
- Support continuous improvement projects
- Support process validation activities including protocol execution and data analysis
- Perform and/or oversee sample preparation and testing (Tensile BFR DSC Chemical) ensuring data integrity and accuracy
- Lead inspection activities and decision-making for mill products (Bar Coil Wire Thick Sheet) including disposition recommendations
- Author and revise quality procedures
- Conducting training including onboarding of new employees
- Other duties as necessary
Required Qualifications
- High school diploma or equivalent
- Minimum 3 year experience in a quality role such as inspector analyst technician etc.
- Demonstrated technical writing and communication skills.
- Proven ability to work independently and lead technical tasks
Preferred Qualifications
- Associate degree or equivalent
- 5 years experience in a Quality Engineering Technician role for a medical device manufacturer or equivalent experience
- Familiarity with ISO and FDA compliance Six Sigma Green Belt
Physical Demands
- Primarily light office work
- May involve bending and lifting of light to medium weight objects.
Compensation
- The compensation for this role is competitive and will be based on experience and qualifications. Theanticipatedrange is $22 - 36/hr.
- Our company policy is that we are unable to provide visa sponsorship. Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.
Required Experience:
Senior IC
About Company
We understand the fast-paced medical device development process and the importance of time-to-market. Let us help bring your breakthrough medical devices and diagnostics to market faster.