QA & Regulatory Compliance Specialist

Bassett Mechanical•Kaukauna, WI

About The Position

The Quality Assurance and Regulatory Compliance Specialist oversees the company’s quality systems and regulatory compliance activities, ensures alignment with ISO standards and applicable requirements, maintains and administers document control systems, and works collaboratively across the organization. This role plays a critical part in identifying quality issues, coordinating internal and external audits, managing corrective actions, and supporting compliance readiness. The role also emphasizes documentation, training, and sustained adherence to regulatory and quality requirements across the organization.

Requirements

3+ years of experience in quality assurance, regulatory compliance, auditing, or related roles.
Proven experience with ISO standards (e.g., ISO 9001) and internal auditing.
Strong understanding of quality management systems, regulatory requirements, and compliance methodologies.
Demonstrated leadership in coordinating audits and testing processes.
Proficiency in Microsoft Office Suite and quality management software.
Exceptional organizational, analytical, and problem-solving skills.
Effective communication and collaboration abilities across diverse teams.
Proactive and results-oriented with a strong compliance and accountability mindset.
Flexible and adaptable to dynamic organizational needs.
Committed to professional growth and staying current with industry trends

Nice To Haves

Bachelor’s degree in Quality Management, Regulatory Affairs, or a related field (preferred) or equivalent experience.

Responsibilities

Provide strategic guidance on ISO compliance and ensure alignment with standards.
Monitor and manage the quality action system to ensure timely resolution of issues.
Lead root cause analysis and develop corrective actions for non-conformities.
Analyze quality trends and collaborate with teams to implement preventive measures.
Coordinate scheduling and preparation for ISO and other external customer/regulatory audits.
Lead the internal audit team and perform internal audits.
Develop and maintain audit documentation and train internal auditors.
Track and oversee the resolution of audit findings to ensure compliance.
Maintain and oversee document control systems, ensuring accuracy and accessibility of records.
Manage document change requests and approval workflows.
Create and update quality documentation, including procedures and work instructions.
Monitor regulatory requirements and internal obligations to ensure ongoing compliance across applicable quality systems.
Support regulatory inspections, customer requirements, and compliance assessments by coordinating documentation and evidence.
Partner with internal teams to address compliance gaps, implement corrective actions, and maintain readiness for audits and reviews.
Promote awareness of regulatory obligations through training, documentation updates, and standardized compliance practices.
Partner with cross-functional teams to address quality issues and share findings.
Prepare and present reports on quality trends, audit outcomes, compliance status, and corrective actions to leadership.
Act as a liaison between departments to align quality goals with organizational objectives.
Support and maintain a safe and Lean work environment.
Other duties as assigned.