E-Quality Lead

INNOVIZE & XCEL SCIENTIFIC•Vadnais Heights, MN

4d•$31 - $35

About The Position

The Quality Lead is a high-impact role responsible for overseeing the development, implementation, maintenance, and continuous improvement of the Quality Management System (QMS) to ensure full compliance with applicable industry standards, customer requirements, and regulatory frameworks. This role serves as the subject matter expert and primary liaison between the Quality department and all internal and external stakeholders, driving cross-functional alignment on quality processes and initiatives. This role requires strategic thinking, strong analytical capabilities, hands-on leadership, and a deep commitment to quality excellence. The Quality Lead acts as both a tactical executor and a strategic partner, with the responsibility to lead audit readiness, day to day quality operations, maintain robust systems, resolve quality issues at the root, and ensure an organizational culture of continuous improvement and compliance.

Requirements

3+ years related experience in a medical device or biotech manufacturing environment with a good understanding of current Good Manufacturing Practices.
Knowledge of ISO 9001 standards.
3+ years experience supporting ECO’s, NCR’s, CAPA’s.
3+ years experience in leading QMS processes.
3+ years supporting audits.
3+ years in Document Control.
Proficiency in MS Office and Outlook.
Independent, self-starter with exceptional communication (written and verbal) skills, detail-oriented, organized, and able to prioritize and balance department workloads in a fast-paced environment.
Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Ability to write reports, business correspondence, and procedure manuals.
Ability to respond to common inquiries or complaints from employees, customers, or regulatory agencies.
Ability to effectively present information and respond to questions as needed.
Conversion from decimal to metric, area, and other generally used mechanical measurements.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Must interpret various technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Demonstrated background in organizational structure, operational system, and controls, including procedure documentation, training, and audit processes.
Knowledge of Quality improvement philosophy and techniques.
Baseline knowledge in use and understanding of rulers, calipers, eye loops, and other inspection equipment.
Strong written and verbal presentation skills.
Light Work - Lifting of 20 pounds maximum
While performing the duties of this job, the employee is regularly required to talk or hear.
The employee frequently is required to stand; walk; and use hands to finger, handle or feel objects, tools, or controls.
The employee is occasionally required to sit and reach with hands and arms.
This job's specific vision abilities include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

Nice To Haves

Competency in SharePoint workflow development and other SharePoint collaboration features is a plus.
Experience with electronic quality management systems software a plus.

Responsibilities

Quality Management System (QMS) Oversight & Compliance Own and maintain the company's QMS, ensuring systems and procedures are effective, efficient, scalable, and compliant with ISO and other applicable standards and regulations.
Continually monitor and evaluate the QMS for improvement opportunities; develop and implement system enhancements to strengthen operational effectiveness and compliance.
Create, revise, and manage the control of QMS-related documentation including procedures, work instructions, and forms, ensuring alignment with regulatory and customer expectations.
Perform regular audits of QMS records, logs, and documentation for accuracy, completeness, and proper archival, driving document control integrity and traceability.
Cross-Functional Representation Act as the main point of contact and representative of the Quality team across departments.
Provide QMS process clarifications to associates.
Serve as the liaison for quality-related issues in cross-functional meetings.
Attend and participate in Tier meetings, leadership huddles, and cross-departmental initiatives to ensure quality is integrated into decision-making and daily operations when needed Support leadership with the development and coaching of the Quality team, ensuring depth in QMS knowledge.
Demonstrate a high level of professionalism when communicating areas of concern, systemic gaps, or compliance risks—particularly when engaging with leadership or external parties—ensuring issues are addressed constructively, transparently, and with appropriate urgency.
Training & Organizational Readiness Lead and manage the QMS Training Program for all employees, ensuring proper onboarding, refresher training, and ongoing awareness of quality responsibilities and expectations.
Maintain training records and proactively report outstanding training requirements to leadership for follow-up and resolution.
Nonconformance & Root Cause Management Lead investigations and resolution of quality events, including Nonconformance Reports (NCRs), Corrective Action Requests (CARs), Customer Complaints.
Participate in Supplier Corrective Action Requests (SCARs) as necessary.
Perform in-depth root cause analyses (RCA) using structured problem-solving tools and facilitate cross-functional teams in the identification, implementation, and verification of effective corrective and preventive actions (CAPAs).
Own the end-to-end closure process for CARs, DCNs, and Complaints, ensuring timeliness, accuracy, and regulatory compliance.
Supplier & Customer Interface Lead the management and reporting of customer complaints, coordinating investigations and responses that meet or exceed customer expectations.
Interface with customers and suppliers as needed during audits, inquiries, or complaint escalations.
Audit & Inspection Readiness Lead the planning, coordination, and execution of internal audits across departments to monitor QMS adherence.
Act as the lead representative during external audits (ISO, customer, regulatory), including preparation, hosting, documentation management, and post-audit follow-ups.
Organize and conduct mock audits and gap analyses to ensure the organization is audit-ready at all times.
Performance Monitoring & Reporting Define, track, and report key performance indicators (KPIs) for quality system processes including NCRs, CARs, complaints, training compliance, audit findings, and continuous improvement initiatives.
Conduct data analysis to identify trends, systemic issues, and opportunities for improvement.
Provide regular reports and dashboards to senior leadership highlighting commonalities among complaints, NCRs, CARs, and other quality events — along with recommended corrective actions.
Continuous Improvement Serve as an authorized member of the Material Review Board (MRB), collaborating in the disposition of nonconforming product and associated risk assessments.
Conduct Gemba walks and process observations to assess the real-time effectiveness of procedures and identify optimization opportunities.
Lead and facilitate quality improvement projects using Lean, Six Sigma, or similar methodologies.
Collaborate cross-functionally to drive improvements in product quality, operational efficiency, and customer satisfaction.
Additional Responsibilities Escalate critical quality risks to leadership with urgency and clear impact assessments.
Maintain an up-to-date knowledge of regulatory changes and emerging trends; propose updates to internal systems accordingly.
Communicate company values, quality objectives, and strategic vision to all associates.
Perform duties of other Quality roles as needed, ensuring department coverage and continuity.
Support and enforce all company health and safety regulations.
Execute additional tasks and responsibilities as assigned.