Quality Inspector Technician
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Summary
Inspects and tests medical orthosis components and devices at multiple stages to ensure compliance with quality standards before shipment.
Why should you join our success story?
Based on patented technology developed at MIT, Harvard Medical School and by the Company, Myomo develops and markets the MyoPro® product line of lightweight, non-invasive, powered arm braces (orthoses) to restore function in paralyzed or weakened arms and hands of individuals that have suffered a stroke, spinal cord, or nerve injury. (E.g. brachial plexus injury or other neuro-muscular disabilities.) It is the only device that, sensing a patient’s own neurological signals through non-invasive wearable sensors, can restore the ability to use their arms and hands so that they can live independently, increase their quality of life, reduce cost of care, and return to work. Published clinical research shows a clinically significant instantaneous reduction in upper extremity impairment with the MyoPro. Our technology has been referred by leading-edge rehabilitation facilities including Mayo Clinic, Kennedy Krieger Institute, Cleveland Clinic, Loma Linda Medical Center, Massachusetts General Hospital, numerous VA Hospitals, and more. Myomo is headquartered in Burlington, Massachusetts, with sales and clinical professionals across the U.S.
What we’re looking for:
What we’re looking for:
The core responsibility of the Quality Inspector Technician role is to perform quality inspections while providing overall support to both Quality and cross-functional departments/stakeholders as necessary.
Additional responsibilities include conducting inspection of incoming orthosis design components, mid-process checks, and a final outgoing inspection on devices prior to shipment. The Quality Inspector Technician will initiate NCMRs for nonconforming materials and devices, offering testing support to quality and engineering as well.
The ideal candidate is a process-oriented, and systematic-minded professional with both previous regulatory compliance background as well as an appreciation for consistency, standardization, and accuracy. He/she will demonstrate strong attention to detail as well as the capability to thrive an evolving environment, all while driving back to processes and procedures.
The ideal candidate is a process-oriented, and systematic-minded professional with both previous regulatory compliance background as well as an appreciation for consistency, standardization, and accuracy. He/she will demonstrate strong attention to detail as well as the capability to thrive an evolving environment, all while driving back to processes and procedures.
- Conduct inspection of incoming product components.
- Initiate NCMRs for nonconforming materials; conducting data collection and testing for NCMRs as appropriate.
- Ability to sort materials and components as needed.
- Assist with rework, device servicing, and repairs. (NCMRs)
- Perform in-process quality inspections and checks, as well as final inspection and device testing prior to outgoing shipments.
- Provide quality support to New Product Development, as well as execution of tasks and assignments for QC Manager on an ad hoc basis.
- 2+ years' electro-mechanical device quality inspection background within the medical device industry, or similar.
- Familiarity with components, materials testing, inspection tools, product rework, and equipment.
- Strong attention to detail and a disciplined work ethic.
- High school diploma or GED required. Some college may be a plus.
- FDA – GMP experience and training a plus.
- Technical training and/or certifications a plus.
- Teamwork-oriented mindset with the ability to follow work instructions and procedures systematically as well as a capability to complete and submit documentation accurately and promptly.