Quality Engineer

Quality Engineer Location: St. Paul, MN, US, 55128 Murata Viosis a global medical device company dedicated to creating a paradigm shift in the way healthcare is delivered. Through the utilization of our internet-of-things medical-grade sensors and virtual patient care services, we plan to lower the cost of healthcare and improve patient outcomes. Murata Viosis seeking qualified individuals who contribute to our vision through sound product development engineering practices and passionate sales and marketing leadership. Why Consider This Job Opportunity The Quality Engineer supports the development, maintenance, and continuous improvement of the work site's Quality Management System (QMS). This position is focused on learning and assisting with routine quality activities such as document control, internal audits, CAPA, change control, nonconforming product, and customer complaint tracking. The Quality Engineer will gain exposure to FDA, ISO, and other regulatory requirements. Workplace Policy Hybrid from Woodbury, MN What To Expect (Essential Job Responsibilities) Assist in maintaining QMS documentation (SOPs, work instructions, forms) and ensuring document control activities are current. Support the change control process which includes preparing change requests, routing for review, and filing records. Participate in internal, external, and supplier audits and audit followup as well as documenting findings and tracking corrective actions under guidance. Assist in investigating customer complaints and documenting results in the complaint handling system. Help manage CAPAs which includes collecting data, drafting CAPA records, monitoring implementation progress, and verifying effectiveness. Maintain calibration and training records for equipment and personnel as assigned. Miscellaneous Job Responsibilities Participate in quality improvement projects and crossfunctional team meetings as directed. Assist in preparing for external audits and inspections. Support regulatory submission activities by gathering and assembling required QMS records. What Is Required (Qualifications) Bachelor's Degree in Engineering, Life Sciences, or a related technical discipline. Experience in a quality role within an ISOcertified environment or manufacturing setting. Familiar with basic quality tools and terminology (e.g., audit, CAPA, document control). Proficiency with Microsoft Office Suite. Ability to organize, take notes, and manage Microsoft Teams meetings with domestic and international team members. Interpersonal skills including effective collaboration and communication skills. Adaptable with the ability to work in an ever-changing environment. How To Stand Out (Preferred Qualifications) Experience working in an ISO 13485:2016 or FDA 21 CFR Part 820 environment. Internship, Coop, or job experience in a medical device or regulated industry. Experience with electronic QMS platforms (e.g., eQMS). 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. Other Minimum Salary: $79,202 Maximum Salary: $106,032 We consider various factors in determining actual pay including your skills, qualifications, and experience. In addition to salary, this position is eligible for incentive awards based on individual and business performance as well as competitive benefits. Create a better life for patients, clinicians, and hospital administrators by joining the Murata Viosteam. Murata Viosoffers competitive compensation and comprehensive benefits. Equal Opportunity/Affirmative Action Employer - M/F/Disabilities/Veterans Nearest Major Market: Minneapolis pSemi Corporation supports a diverse workforce and is committed to a policy of equal employment opportunity f r applicants and employees. pSemi does not discriminate on the basis of age, race, color, religion (including religious dress and grooming practices), sex/gender (including pregnancy, childbirth, or related medical conditions or breastfeeding), gender identity, gender expression, genetic information, national origin (including language use restrictions and possession of a driver s license issued under Vehicle Code section 12801.9), ancestry, physical or mental disability, legally-protected medical condition, military or veteran status (including protected veterans under applicable affirmative action laws), marital status, sexual orientation, or any other basis protected by local, state or federal laws applicable to the Company. pSemi also prohibits discrimination based on the perception that an employee or applicant has any of those characteristics, or is associated with a person who has or is perceived as having any of those characteristics.