QMS/ISO Compliance Specialist

Micro-Matics•Minneapolis, MN

3d•Onsite

About The Position

Micro-Matics Inc. is a leader in providing high quality precision Swiss components and assemblies to some of the largest companies in the medical, aerospace, and commercial industries. We offer competitive wages, and a comprehensive benefits package with a safe and clean working environment. The QMS / ISO Compliance Specialist is responsible for developing, maintaining, and improving the company’s Quality Management System (QMS) to ensure compliance with applicable standards, customer requirements, and regulatory expectations. This role owns the quality system infrastructure including documentation control, audits, corrective action systems, training compliance, and management review processes.

Requirements

Leadership - setting a high standard and leading by example
Good communication skills
Knowledge of calibration system
Management of Employees as well as sitting down and doing the job right alongside them
Strong contributor to a positive culture
Organizational Skills
Customer Service - Internal & External
ISO13485 & AS9100 Certification and Compliance Requirements
Bachelor’s degree or equivalent experience
2-year post education or a minimum of 5 years relevant experience

Responsibilities

Quality Management System Administration: Develop, maintain, and improve the company QMS in accordance with applicable standards such as International Organization for Standardization ISO 9001, International Organization for Standardization AS9100, International Organization for Standardization ISO 13485, or customer-specific requirements. Ensure company policies, procedures, forms, and work instructions remain current and controlled. Lead system improvements that support scalability, efficiency, and growth.
Document Control: Manage document revision control, approvals, distribution, retention, and archival systems. Ensure obsolete documents are removed from use. Maintain electronic and hardcopy controlled documentation.
Internal & External Audits: Plan and manage internal audit schedules. Lead registrar, customer, and regulatory audits. Coordinate responses to audit findings and verify closure of corrective actions. Train internal auditors as needed.
CAPA / Corrective Action System: Administer company corrective and preventive action systems. Ensure root cause investigations are documented, timely, and effective. Track open actions and drive closure accountability.
Training & Compliance Records: Maintain training matrices and quality-system training records. Ensure employees are trained to current procedures and revisions. Support onboarding compliance training.
Management Review & Metrics: Prepare management review reports and meeting materials. Track KPIs related to audit performance, CAPA status, document changes, training completion, and system effectiveness. Recommend strategic improvements to leadership.
Cross-Functional Collaboration: Partner with the Quality Manager to align shop-floor practices with documented procedures. Support Engineering, Operations, HR, Purchasing, and Leadership on compliance initiatives. Assist with new customer approvals, certifications, and qualification requirements.
Continuous Improvement: Identify inefficiencies within the QMS and recommend simplification or automation. Support digitalization of quality systems where appropriate.