Quality Systems Specialist (Mid-Level)

Job Description

Job Description

Quality Systems Specialist (Mid-Level)

Job Summary

The Quality Systems Specialist maintains and improves the organization's quality management system (QMS), administers quality programs across departments, and leads or supports internal and external audits. This role ensures compliance with applicable regulatory and industry standards while driving continuous improvement.

Key Responsibilities

• Implement, maintain, and improve quality system programs (e.g., document control, CAPA, change control, nonconformance management, training records).
• Administer the QMS platform, including document approvals, workflow routing, and system access.
• Plan, coordinate, and conduct internal audits; support external/regulatory audits and certification assessments (e.g., ISO 9001, ISO 13485, AS9100, as applicable).
• Track audit findings through to closure and verify effectiveness of corrective and preventive actions (CAPA).
• Develop and revise SOPs, work instructions, and quality records to reflect current processes and regulatory requirements.
• Analyze quality metrics and trends; prepare reports for management review.
• Partner with operations, engineering, and regulatory affairs to resolve quality issues and drive root cause analysis.
• Deliver quality system training to employees and new hires.
• Support supplier quality activities, including supplier audits and scorecards, as needed.

Qualifications

• Bachelor's degree in a related field (Quality, Engineering, Life Sciences, or equivalent experience).
• 3–5 years of experience in quality systems, quality assurance, or a related role.
• Working knowledge of quality standards/frameworks (ISO 9001, ISO 13485, AS9100, FDA 21 CFR Part 820, or industry equivalent).
• Experience administering a QMS or electronic document management system (e.g., MasterControl, Veeva, ETQ).
• Demonstrated experience planning and executing internal audits; familiarity with external audit support.
• Strong root cause analysis and CAPA management skills (e.g., 5-Why, fishbone/Ishikawa).
• Excellent written and verbal communication skills; ability to write clear technical documentation.
• Proficiency with Microsoft Office/Excel; data analysis skills a plus.

Preferred

• ASQ certification (CQA, CQE, or CMQ/OE).
• Lead Auditor certification.
• Experience in a regulated manufacturing, medical device, aerospace, or pharmaceutical environment.

Physical/Work Requirements

• Ability to work on-site with occasional travel for supplier or facility audits.

\nCompany Description

Our high-reliability and high-accuracy temperature sensors are primarily used in aerospace, defense, and energy applications, among others. RdF actively serves the U.S. and commercial space industry, and has proudly supported every manned U.S. space mission.
RdF Corporation is an ISO9001 and AS9100 registered company.

Company Description

Our high-reliability and high-accuracy temperature sensors are primarily used in aerospace, defense, and energy applications, among others. RdF actively serves the U.S. and commercial space industry, and has proudly supported every manned U.S. space mission.\r\nRdF Corporation is an ISO9001 and AS9100 registered company.