QMS/ISO Compliance Specialist
Micro-Matics Inc. · Minneapolis, MN · 1 wk ago
On-siteFinanceFull-time
About the role
Micro-Matics Inc. is a leader in providing high-quality precision Swiss components and assemblies to the medical, aerospace, and commercial industries. We offer a safe and clean working environment.
Responsibilities
- Quality Management System Administration
- Develop, maintain, and improve the company QMS in accordance with applicable standards such as ISO 9001, AS9100, 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.
Requirements
- Bachelor’s degree or equivalent experience
- 2-year post-education or a minimum of 5 years relevant experience
Skills
- Leadership – setting a high standard and leading by example
- Good communication skills
- Knowledge of calibration systems
- Management of employees as well as hands-on contribution
- Strong contributor to a positive culture
- Organizational skills
- Customer service – internal & external
- ISO 13485 & AS9100 certification and compliance
Benefits
- Competitive wage
- Paid PTO & holidays
- Medical, dental, vision, H.S.A
- 401k & match
- Monthly & annual incentive plan