The Quality Compliance Specialist is responsible for supporting operations in the maintenance of the quality management system. This role ensures that all operational quality events are accurately recorded, thoroughly investigated, and that robust corrective actions are implemented and their effectiveness measured. The Operational QA Specialist is responsible for scheduling and performing quality audits to ensure the company quality processes and procedures are in compliance with AS9100, ISO9001, ISO14001, ISO45001, ISO17025, AS6081, AS6171, and ANSI/ESD S20.20.
Key Responsibilities
Maintains working knowledge of applicable regulatory requirements. Point of contact for all operational quality events and customer liaison responsibilities. Actively participates in operational quality event investigation, outcomes, and effectiveness checking. Actively participates in continuous improvement. Participates in the training of colleagues on the requirements surrounding investigations, documentation, and records management. Communicates best practices to staff during department meetings and assists in group training as directed. Performs analysis of data (monthly metrics). Writes, reviews, and updates SOPs. Ensures documentation is current and available for use. Receives and coordinates external customer documentation. Coordinates records management activities between Retronix sites to ensure effective and efficient compliance with all applicable laws and regulations. Reviews and maintains records retention schedules; participates in maintaining compliance with corporate and site document and records management programs, systems, and procedures. Maintains and updates logs and/or databases used for tracking records. Performs routine internal/method witness audits and generates reports to management. Assists in regulatory audits. Job Qualifications & Knowledge Requirements
Experience and knowledge of ISO9001, ISO17025, ISO13485, AS9100, or GMP. Demonstrable knowledge of investigation techniques. Experience with compliance assessments, gap assessments, and risk management assessments beneficial. Experience with program change management practices, lean or six sigma, program, and system integration efforts beneficial. Strong computer skills; Word, Excel, PowerPoint. Strong interpersonal skills are required. Must be an effective team player intra-departmentally and cross-functionally. Education & Experience Requirements
Bachelor’s degree required (Quality, Regulatory, Engineering, Business, or Life Sciences). 2+ years of industry experience within Quality and/or Regulatory field. Internal auditing certification or lead auditor certification highly desirable. Or a combination of education, experience, and/or training. Electronic or engineering background highly desirable.
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Maintains working knowledge of applicable regulatory requirements. Point of contact for all operational quality events and customer liaison responsibilities. Actively participates in operational quality event investigation, outcomes, and effectiveness checking. Actively participates in continuous improvement. Participates in the training of colleagues on the requirements surrounding investigations, documentation, and records management. Communicates best practices to staff during department meetings and assists in group training as directed. Performs analysis of data (monthly metrics). Writes, reviews, and updates SOPs. Ensures documentation is current and available for use. Receives and coordinates external customer documentation. Coordinates records management activities between Retronix sites to ensure effective and efficient compliance with all applicable laws and regulations. Reviews and maintains records retention schedules; participates in maintaining compliance with corporate and site document and records management programs, systems, and procedures. Maintains and updates logs and/or databases used for tracking records. Performs routine internal/method witness audits and generates reports to management. Assists in regulatory audits. Job Qualifications & Knowledge Requirements
Experience and knowledge of ISO9001, ISO17025, ISO13485, AS9100, or GMP. Demonstrable knowledge of investigation techniques. Experience with compliance assessments, gap assessments, and risk management assessments beneficial. Experience with program change management practices, lean or six sigma, program, and system integration efforts beneficial. Strong computer skills; Word, Excel, PowerPoint. Strong interpersonal skills are required. Must be an effective team player intra-departmentally and cross-functionally. Education & Experience Requirements
Bachelor’s degree required (Quality, Regulatory, Engineering, Business, or Life Sciences). 2+ years of industry experience within Quality and/or Regulatory field. Internal auditing certification or lead auditor certification highly desirable. Or a combination of education, experience, and/or training. Electronic or engineering background highly desirable.
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