What are the responsibilities and job description for the Sr. Quality Engineer position at Neuros Medical, Inc.?
About the Job
The Sr. Quality Engineer provides Quality Engineering and Quality Assurance support, including product inspection, test and release activities, design assurance activities, risk management, complaint investigation, returned goods authorization, and supplier management change order. The position will be part of our Quality Assurance team, and located on-site in Neuros Medical’s Arden Hills, Minnesota headquarters. The role includes:
Responsibilities
· Execute and maintain quality control and quality engineering processes, for all routine product related activities.
· Manage quality aspects of supplier relationships, ensuring that purchased materials and components meet quality requirements.
· Determine product disposition and provide recommendations regarding product quality to management as needed for various processes such as NCR, CAPA, Hazard Assessments, Field Actions, RGA, and Complaints.
· Lead investigation efforts, including root cause analysis, corrective actions, and problem-solving activities for product and product related manufacturing issues.
· Develop, document, and implement statistically valid sampling plans, designed experiments, capability studies, SPC, and trend analysis reports in support of product investigations and improvements.
· Serve in a technical role to provide expertise in the following areas: product development, risk management, product inspection, test and release, test method/process validation, and statistical methods in compliance with applicable FDA regulations, ISO standards, and other relevant requirements.
· Ensure compliance with regulatory standards and internal quality protocols throughout the manufacturing process.
· Support the calibration and preventive maintenance programs to ensure equipment accuracy and reliability.
· Serve as a core team member on cross-functional new product development teams.
· Support and prepare for regulatory inspections and during 3rd party audits to ensure positive compliance outcomes.
Qualifications
· Strong interpersonal skills with the ability to effectively communicate technical information to various levels within the organization and externally to suppliers.
· Knowledge of regulations pertinent to the medical device industry.
· Proficient and knowledgeable in engineering tools, such as Minitab. Proficient in MS office applications (Excel, Word, PowerPoint).
Education and Experience
· Formal education in science, engineering, or biological sciences and/or minimum of 5-7 years in the medical device industry or related industries.
· A minimum of 5-7 years in technical QA roles with demonstrated progressive increase in responsibility
· Active implantable medical device experience is preferred.
About Neuros Medical, Inc.
There are over two million amputees in the U.S., with an estimated 185,000 new amputations occurring every year. Post-amputation pain includes both phantom limb pain and residual limb pain and impacts nearly one million Americans, representing a significant unmet medical need as existing treatment options are limited and consist primarily of opioids and gabapentinoids. Neuros Medical is a privately held company and the maker of the Altius® Direct Electrical Nerve Stimulation System designed for the treatment of chronic post-amputation pain. Our mission is to reduce pain and restore life for people suffering with post-amputation pain. We are a passionate team guided by our core values and committed to our patients and the healthcare professionals who care for them.
Our Core Values:
Patients First, Deliver Excellence, Responsible Ambition, Inspire and Empower.