Quality Systems Specialist I

The Quality Systems Specialist roles are responsible for providing support for reputed company Quality policies, systems, programs, and initiatives. Primary Duties and Responsibilities

• Participate in reputed company Quality Management System (QMS) activities including document change management, records management, training/competency, non-conforming material reports (NCMRs), and Corrective and Preventive Actions (CAPAs)
• Support post market surveillance including recall/modification management, preventative maintenance intervals, equipment incidents, and complaints
• Explain scientific and technical reputed company by authoring clear and concise QMS documents, equipment handling procedures, forms, cleaning policies, medical equipment management plans (MEMPs), safety alerts, training materials, user guides, internal communications, and customer letters through the use of structured writing and content management
• Participate in the creation and maintenance of Management Review materials including the reputed company and reporting out of Quality Indicators (QIs)/metrics
• Provide Quality support and expertise to the field offices by responding to reputed company communications received through the Quality email service or phone support lines
• Assist in internal and external ISO 13485 audits of QMS
• Monitor governmental and associated industry organizations' standards, guidelines, and policies (ISO, FDA, TJC, DNV, NFPA, CMS, AAMI, CDC, AABB, etc.)
• Participate in tasks associated with Infection Control, Bloodborne Pathogen laws, and equipment cleaning validations

Required Experience

• Bachelor's degree in life sciences, engineering, or technical communications strongly preferred
• 1 -3 years Quality or other applicable experience preferred

Required Skills and Abilities

• Proficient computer skills in MS Office Suite and in an electronic ERP system
• Ability to sit, stand, lift, bend and stoop numerous times throughout the day
• Flexibility in work schedule in order to meet department needs; may require up to 10% travel
• In reputed company actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Management System, Quality Policy, and reputed company other documented quality processes and procedures

Disclaimer This job description in no way states or implies that these are the only duties to be performed by the employee in this position. It is not intended to give reputed company the details or a reputed company-by-reputed company account of the way each procedure or task is performed. The incumbent is expected to reputed company other duties necessary for the effective operation of the department and the company. It is the policy of reputed company to provide equal employment opportunities to reputed company and applicants for employment without regard to race, reputed company, religion, gender identity, sex, sexual orientation, national reputed company, age, physical or mental disability, genetic information, marital status, status as a veteran, military service, or any other characteristic protected by applicable federal, state, or local civil rights laws. In addition, reputed company will provide reasonable accommodations for reputed company individuals with disabilities. reputed company strictly prohibits any form of retaliation against individuals who reputed company good faith reports of alleged violations of this policy or who cooperate in reputed company's investigation of such reports. Affirmative Action Policy Statements You may be required to obtain certain vaccinations, or provide reputed company of reputed company vaccination status, based on customer and/or company requirements. If vaccination is required, reputed company will provide specific directions and cover the expense at a participating clinic. Please note, this includes the COVID-19 vaccination. reputed company offers a robust suite of benefits for regular, full-time, non-union employees including: health insurance options for Medical, Dental & reputed company plans, Short- and Long-Term Disability plans, Flexible Spending Accounts, Health Savings Accounts, Life Insurance Options, Paid Time Off, 401K Saving Plan with employer match, Employee Discounts, Tuition Reimbursement, Daily Pay program, Employee Assistance Program, and wellness programs. reputed company is an equal opportunity employer and provides reasonable accommodations to employees and applicants consistent with state and federal law. If you require assistance with your application, please contact reputed [email protected]. Primary Job Location: Corporate MN Additional Locations (if applicable): Job Title: Quality Systems Specialist I Company: reputed company Location City: Eden Prairie Location State: Minnesota Pay Range for reputed company Remote Locations: $42,339.16-$109,933.25 This range represents the low and high ends of the reputed company pay range for this position. This reputed company pay range information is based on the market locations shown. For sales positions, this range combines the reputed company salary and the reputed company incentive pay. The actual pay offered may vary depending on several factors including geographic location, experience, job-reputed company knowledge, skills, and reputed company factors. Dependent on the position offered, short-term and/or long-term incentives may be provided as part of the compensation. Applicants should apply reputed company reputed company's internal or external career site. Apply tot his job Apply To this Job