Quality Systems Specialist II

Elucent Medical•Eden Prairie, MN

1d•Onsite

About The Position

The Quality Systems Specialist II owns and continuously improves multiple elements of Elucent Medical’s quality management system, with primary ownership of the Corrective and Preventive Action (CAPA) and internal audit programs. The role oversees the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with company policies and applicable internal and external standards and regulations. Working cross-functionally with process stakeholders, the specialist ensures quality processes are appropriately documented, completed on time, and effective. The position operates with a high degree of independence and exercises judgment regarding investigation scope, root cause, risk, and corrective-action adequacy. It coordinates preparation of document packages for internal audits, FDA inspections, and external audits, and supports the Quality Director and Regulatory Affairs with quality-system content for regulatory submissions. The specialist may provide technical guidance and backup support to other Quality Systems staff but has no direct reports. The position is full-time, Monday through Friday, 40 hours per week, and is performed in person. The work environment includes an office and manufacturing floor, with less than 10% travel. Physical demands include prolonged sitting and computer work and occasionally lifting up to 15 pounds.

Requirements

Bachelor’s degree in engineering, life sciences, or a related technical field; an equivalent combination of education and directly relevant experience will be considered.
At least 5 years of relevant medical device quality systems/ISO 13485 experience.
Demonstrated ownership of at least two quality system elements, one of which must be CAPA or internal audit.
Demonstrated experience leading CAPA investigations using structured root cause analysis methods and verifying corrective-action effectiveness.
Demonstrated experience leading internal audits.
Direct experience supporting FDA inspections or third-party quality system audits.
Technical writing skills and excellent written and oral communication skills.
Excellent computer skills, including MS Office, Adobe Acrobat, and electronic QMS (eQMS) platforms.
Working expertise in medical device quality management systems, including 21 CFR Part 820 (QMSR) and ISO 13485; familiarity with ISO 14971 risk management.
Hands-on approach, strong organizational and time-management skills, and ability to work in a self-directed team environment.
Ability to work independently with minimal supervision and exercise sound judgment on investigation scope, risk, and corrective-action adequacy.
Ability to apply the medical device regulatory environment to day-to-day quality decisions.
Ability to work effectively on cross-functional teams, establish appropriate quality processes, and influence and facilitate teams without direct authority.
Ability to formulate responses to inquiries from internal and external customers and regulatory agencies, including responses to audit and inspection observations.
Ability to review, analyze, summarize, and interpret data; draw conclusions; and make appropriate recommendations and decisions.
Must be legally authorized to work in the United States for any employer; visa sponsorship is not provided.

Nice To Haves

ISO 13485 Lead Auditor certification or ASQ Certified Quality Auditor (CQA).

Responsibilities

Ensure quality systems documentation and recordkeeping activities comply with established procedures and work instructions.
Serve as system owner for two or more quality system elements, managing system effectiveness and related activities such as procedure ownership, training, issue resolution, and metrics reporting.
Support timely completion of document change requests (DCRs), CAPAs, and corrections.
Plan, schedule, and lead the internal audit program, including audit execution, reporting, follow-up of findings to closure, program records, and auditor qualifications.
Control and maintain externally supplied documentation other than prints and specifications, as required.
Coordinate collection and reporting of quality metrics and trends, identify adverse trends, and initiate appropriate action.
Author, revise, and improve quality systems procedures; perform gap assessments against 21 CFR Part 820 (QMSR), ISO 13485:2016, and related standards; and drive remediation.
Lead preparation for FDA inspections and external audits and serve as a front-room or back-room representative, coordinating document requests, drafting responses to observations, and managing associated corrective actions.
Develop and deliver training on owned quality system elements and define training requirements for related procedure changes.
Compile and analyze quality system inputs for Management Review, present data and recommendations, and track resulting actions to closure.
Drive continuous improvement of quality system processes and eQMS workflows and serve as a subject matter expert on QMSR and ISO 13485 requirements.
Support Regulatory Affairs with quality system documentation and evidence for regulatory submissions.
Provide technical guidance, review, and backup support to Quality Systems staff responsible for quality system elements.
Demonstrate safe work habits and maintain a clean and safe work area.
Complete other duties assigned by the supervisor.