Quality Systems Manager

Quality Systems Manager Imricor Medical Systems Inc Burnsville, MN Job Details Full-time $130,000 - $165,000 a year 1 day ago Benefits Health savings account Disability insurance Health insurance Dental insurance Flexible spending account Vision insurance Life insurance Retirement plan Qualifications Regulatory inspections ISO standards Preventive action implementation Quality control preventive actions Corrective and preventive actions (CAPA) Biomedical regulatory compliance Quality audits Cross-functional collaboration Cross-functional team management Cross-functional communication FDA regulations Audit support

Full Job Description Description:

Supervisor's Title:

Quality Director Exempt or Non-Exempt :

Exempt Location:

Must be able to work at our Burnsville location.

Compensation:

The expected salary/wage for this Minnesota-based position is between $130,000-165,000. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate's knowledge, skills, and or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, and Retirement Benefits). Basic Function The Quality Systems Manager is responsible for establishing, maintaining, and continuously improving Imricor's Quality Management System to ensure compliance with all applicable regulatory requirements and standards for medical devices. This role provides leadership across a cross-functional team to ensure quality, regulatory compliance, and inspection readiness throughout the product lifecycle. Responsibilities Quality Management System Leadership o Owns, maintains, and improves the Quality Management System in compliance with 21 CFR Part 820, EU

MDR, ISO

13485, and other applicable international regulations and guidelines. o Ensures effective implementation and ongoing compliance with QMS processes, procedures, and records o Owns and maintains electronic QMS system Documentation and Change Management o Manages document control, record retention, and change control processes o Drives harmonization and simplification of quality documentation where possible o Owns and maintains external document and standards database and drive updates, as applicable

Audits:

o Plans, conducts, and manages internal audits and support external regulatory and customer audits o Acts as the primary interface with regulatory authorities and notified bodies during inspections o Leads audit responses, root cause analysis, and corrective actions to closure CAPA Management o Oversees the Corrective and Preventive Action (CAPA) system, ensuring timely, effective investigations and actions o Analyzes quality data and trends to proactively drive system improvements Complaint Handling o Owns and maintains the Complaint Handling System in compliance with 21 CFR 820.198 and

ISO 13485

o Ensures timely intake, documentation, investigation, and closure of product complaints o Collaborates with Regulatory Affairs to ensure compliance with regulatory reporting and international vigilance requirements o Monitors complaint trends to identify systemic issues and drive continuous improvement Post-Market Surveillance o Leads and maintains Post-Market Surveillance (PMS) processes in accordance with applicable

U.S., EU

MDR, and other applicable international regulations o Collects, analyzes, and evaluates post-market data and prepare post-market reports (PMSR, PSURs) o Partners with cross-functional teams to assess post-market risk and ensure timely implementation of field actions when required Quality Metrics Trending and Reporting o Defines, implements, and maintains quality metrics to monitor QMS performance and effectiveness o Prepares and presents quality performance reports to leadership and Management Review forums o Uses data-driven insights to identify risks, improvement opportunities, and systemic trends Training and Culture o Ensures QMS training programs are effective and current o Promotes a culture of quality, compliance, and continuous improvement across the organization Performs other related duties and responsibilities, as assigned.

Requirements:

Qualifications Bachelor of Science in a scientific discipline or equivalent education/ training 10+ years' experience in Quality Systems; 4+ years within the medical device industry Comprehensive working knowledge of

EU MDR, ISO 13485, 21 CFR 820

Experience leading audits, CAPA systems, and regulatory inspections Proven ability to effectively influence cross-functional teams Working Conditions Light work, exerting up to 20 lbs. of force or less. 85% of time requires viewing and working at computer screen. The statements above reflect the principal function and most significant duties of the job as necessary for its evaluation in relation to other jobs in the organization and shall not be construed as a detailed description of all the work requirements that may be inherent in the job. Any functions that are non-Essential will be identified as such above. A request for Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.