Quality Assurance & Compliance Analyst

Perryman Company; Houston (PA); On-site; USD 60,000 - 90,000; Full time

Job summary

Perryman Company is seeking a Quality Assurance & Compliance Analyst to maintain document control, training records, and CAPA within the quality management system, with routine communication on ETQ. This on-site role requires collaboration across departments and timely handling of audits.

The ideal candidate will have 3–5 years of quality systems experience, familiarity with FDA/ISO standards, and strong MS Excel skills.

Qualifications

• 3–5 years of experience in quality systems administration or manufacturing quality.
• Experience with FDA/ISO 13485 AS9100 and ISO 9001 is a plus.
• Proficiency in Microsoft Office Suite, especially Excel.
• Knowledge of quality tools such as FMEA, SPC, Control Plans, and Process Audits.

Responsibilities

• Verify quality records meet customer and regulatory requirements.
• Ensure all documents pertaining to the Quality System are controlled and only the latest revisions are in use.
• Ensure retention and accessibility of quality records.
• Generate reports and metrics on quality system performance.
• Schedule Quality System training throughout the facilities as needed. Ensure proper training is conducted and provide training material for all departments as required. Maintain current status of training database by updating revisions to documents, learning paths, or individual employee status and requirements, such as job transfers or cross-training.
• Support compliance with NADCAP requirements and special process controls where applicable.
• Administer the CAPA System, including Customer complaints, corrective / preventive actions, and supplier corrective actions. Track nonconformances, customer complaints, and root cause investigations.
• Assist departments in preparing for regulatory and customer audits.
• Track audit findings and ensure timely completion of corrective actions.
• Prepare audit reports and management review documentation.
• All other duties as assigned.

Skills

Attention to detail

Verbal & written communication

Team collaboration

Prioritization

Education

Bachelor's/Associate in Quality Management or related field

Tools

ETQ

Microsoft Excel

Job description

The Quality Assurance & Compliance Analyst is responsible for maintaining and supporting document control, training records, internal and external audits and corrective and preventive actions (CAPA) within the quality management system along with regular communication with ETQ.

This position is an on-site role.

Key Result Accountabilities

• Verify quality records meet customer and regulatory requirements.
• Ensure all documents pertaining to the Quality System are controlled and only the latest revisions are in use.
• Ensure retention and accessibility of quality records.
• Generate reports and metrics on quality system performance.
• Schedule Quality System training throughout the facilities as needed. Ensure proper training is conducted and provide training material for all departments as required. Maintain current status of training database by updating revisions to documents, learning paths, or individual employee status and requirements, such as job transfers or cross-training.
• Support compliance with NADCAP requirements and special process controls where applicable.
• Administer the CAPA System, including Customer complaints, corrective / preventive actions, and supplier corrective actions. Track nonconformances, customer complaints, and root cause investigations.
• Assist departments in preparing for regulatory and customer audits.
• Track audit findings and ensure timely completion of corrective actions.
• Prepare audit reports and management review documentation.
• All other duties as assigned.

Requirements

Associate's or Bachelor's degree in Quality Management, Engineering, Manufacturing, Business Administration, or a related field, preferred.

3–5 years of experience in quality systems administration, quality assurance, or manufacturing quality, preferred.

Experience in quality management systems software, ETQ experience a plus. Must complete administrator training.

Proficiency in Microsoft Office Suite, particularly Excel.

Experience with FDA, ISO 13485 AS9100, and ISO 9001, ISO 14001 is a plus.

Knowledge of quality tools such as FMEA, SPC, Control Plans, and Process Audits.

Must work with a high attention to detail.

Ability to organize and judge priorities in a dynamic, fast-paced environment and work independently with minimal supervision.

Must possess excellent verbal & written communication skills.

Prolonged periods sitting at a desk and working on a computer.

Must be able to lift up to 15 pounds at times.

Qualifications

Behaviors

Preferred

Team Player

Team Player

: Works well as a member of a group

Detail Oriented

Detail Oriented

: Capable of carrying out a given task with all details necessary to get the task done well

Education

Preferred

Bachelors or better in Business Administration or related field.

Bachelors or better in Engineering or related field.

Equal Opportunity Employer
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