Vios Medical
Overview
Quality Engineering Specialist
at
Vios Medical
– Location: St. Paul, MN, US, 55128. Murata Viosis is a global medical device company focused on improving healthcare delivery and patient outcomes through medical-grade sensors and connected solutions. This role provides exposure to FDA, ISO, and other regulatory requirements while collaborating with Quality Engineers and cross-functional teams. The position supports day-to-day Quality Management System (QMS) activities on the production floor. What to Expect (Essential Job Responsibilities)
Support corrective and preventive actions (CAPA) by gathering data, performing verification checks, and documenting results. Assist with document control tasks, including routing, controlled copy distribution, and ensuring current versions are available at points of use. Assist complaint investigations by coordinating sample pulls, conducting basic tests, and documenting observations. Participate in internal audits as an auditor in training, collecting objective evidence and supporting audit follow-up. Collaborate with Production, Engineering, Supply Chain, and Regulatory to resolve quality issues. Help prepare for external audits and inspections by organizing records and retrieval of QMS documentation. Support regulatory submission activities by locating and assembling required QMS records. Participate in quality improvement initiatives and cross-functional projects as directed. What Is Required (Qualifications)
Bachelor's degree in Engineering, Life Sciences, or a related technical discipline. Familiar with quality system concepts (e.g., audit, CAPA, nonconforming product, document control). Experience in ISO-certified environments (ISO 9001 or ISO 13485) or equivalent. Strong attention to detail, organization, and communication skills with the ability to work independently and in a team environment. How to Stand Out (Preferred Qualifications)
Experience in a medical device or other regulated industry (ISO 13485 and/or FDA 21 CFR Part 820). Experience with electronic QMS platforms and/or ERP systems. ASQ certification (e.g., CQI, CQT) or Internal Auditor training. Perks
Comprehensive benefits package including medical, dental, and vision insurance. Generous Paid Time Off including paid holidays and floating holidays. 401(k) employer match on retirement planning. Hybrid working schedule for eligible positions. Tuition reimbursement on approved programs. Flexible and health spending accounts. Talent Development program. Employment Details
Employment type: Full-time Seniority level: Entry level Job function: Engineering and Information Technology Industries: Hospitals and Health Care Equal Opportunity/Affirmative Action Employer - M/F/Disabilities/Veterans
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Quality Engineering Specialist
at
Vios Medical
– Location: St. Paul, MN, US, 55128. Murata Viosis is a global medical device company focused on improving healthcare delivery and patient outcomes through medical-grade sensors and connected solutions. This role provides exposure to FDA, ISO, and other regulatory requirements while collaborating with Quality Engineers and cross-functional teams. The position supports day-to-day Quality Management System (QMS) activities on the production floor. What to Expect (Essential Job Responsibilities)
Support corrective and preventive actions (CAPA) by gathering data, performing verification checks, and documenting results. Assist with document control tasks, including routing, controlled copy distribution, and ensuring current versions are available at points of use. Assist complaint investigations by coordinating sample pulls, conducting basic tests, and documenting observations. Participate in internal audits as an auditor in training, collecting objective evidence and supporting audit follow-up. Collaborate with Production, Engineering, Supply Chain, and Regulatory to resolve quality issues. Help prepare for external audits and inspections by organizing records and retrieval of QMS documentation. Support regulatory submission activities by locating and assembling required QMS records. Participate in quality improvement initiatives and cross-functional projects as directed. What Is Required (Qualifications)
Bachelor's degree in Engineering, Life Sciences, or a related technical discipline. Familiar with quality system concepts (e.g., audit, CAPA, nonconforming product, document control). Experience in ISO-certified environments (ISO 9001 or ISO 13485) or equivalent. Strong attention to detail, organization, and communication skills with the ability to work independently and in a team environment. How to Stand Out (Preferred Qualifications)
Experience in a medical device or other regulated industry (ISO 13485 and/or FDA 21 CFR Part 820). Experience with electronic QMS platforms and/or ERP systems. ASQ certification (e.g., CQI, CQT) or Internal Auditor training. Perks
Comprehensive benefits package including medical, dental, and vision insurance. Generous Paid Time Off including paid holidays and floating holidays. 401(k) employer match on retirement planning. Hybrid working schedule for eligible positions. Tuition reimbursement on approved programs. Flexible and health spending accounts. Talent Development program. Employment Details
Employment type: Full-time Seniority level: Entry level Job function: Engineering and Information Technology Industries: Hospitals and Health Care Equal Opportunity/Affirmative Action Employer - M/F/Disabilities/Veterans
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