What are the responsibilities and job description for the Quality Systems/Operations Specialist position at Neuros Medical, Inc.?
About the job
Located in our Arden Hills, Minnesota headquarters, the Quality Systems/Operations Specialist will communicate across departments, levels of management and with external suppliers while responsible for maintaining document control processes, tracking various company quality management systems, and conducting other quality operations activities.
This role will be onsite daily in our Minnesota office.
Responsibilities will include:
· Routine processing of controlled document processes, for all controlled documentation in accordance with established procedures.
· Maintain organization of electronic and paper records to ensure easy issuance, storage and retrieval for both internal access and 3rd party regulators.
· Authorize the release of controlled documents when processes have been completed.
· Directly participate in 3rd party audits to demonstrate compliance to internal procedures and applicable regulations such as FDA Quality System Regulation CFR 820 and ISO 13485.
· Communicate internally and externally to suppliers to ensure compliance to established Neuros procedures. Ensure issues with compliance are communicated to management in a timely manner.
· Coordinate and manage documentation for the company’s Approved Suppliers, issuing required forms to initially approve and maintain approval status in our Quality System; also maintains the Approved Supplier List.
· Routinely coordinate and process clinical site materials.
· Conduct quality inspections and execute product release.
· Initiate and document nonconformance reports.
· Coordinate calibration/maintenance programs, as assigned.
· Provide facilities support, such as pest control.
Education and Experience:
Formal education in quality management systems, engineering or biological sciences and/or a minimum of 2-5 years in the medical device industry or related industries.
Skills and Qualifications:
· Ability to effectively communicate across departments, levels of management and with external suppliers.
· Strong interpersonal skills.
· Able to effectively prioritize based on changing needs.
· Must be able to work within assigned timelines.
· Good verbal, written, communication skills.
· Detail-oriented with strong organizational skills.
· Knowledge of regulations pertinent to the medical device industry.
· Proficient in MS office applications (Excel, Word, Power Point, Outlook, Teams, SharePoint), and Adobe.
· Master Control experience helpful, but not required.
Neuros Medical offers competitive health and wealth benefits for our employees. A range of factors, including location, skills, and experience, will be considered.
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; Accountable; Team Before Self; Humility; Deliver Excellence.
Our Mission:
Relieve Pain. Restore Life.