Job Description

QA/RA Manager – Oaks, PA

The QA/RA Manager (Quality Assurance / Regulatory Affairs) is responsible for overall development, implementation, and maintenance of the organization’s Quality Management System (QMS). Oversee production staff and improve upon production processes to increase efficiency in operations. The QA/RA Manager is responsible for global regulatory affairs and quality assurance activities related to regulated manufactured products. The QA/RA Manager is also responsible for advising and consulting with stakeholders about compliance with applicable FDA regulations and other applicable standards for regulated distributed products.

Essential Functions:

• Ensure that the organization’s Quality Management System conforms to customer, internal, FDA, ISO 9001 & 13485, and applicable medical device regulatory/legal requirements.
• Ensure all products consistently meet and pass set quality standards.
• Management of vendors as needed. Ensure evaluation of, and reporting on, vendor quality systems.
• Manage the monitoring, measurement, review of internal processes, and effectiveness checks of the quality systems to continuously improve performance.
• Work with customers, employees, contractors, and outsourcing firms to ensure effective quality processes that meet product requirements.
• Conduct internal audits and provide guidance regarding best practices and continuous improvement.
• Report to top management on the performance of the QMS (e.g., results of quality audits, corrective actions), including the need for improvement.
• Identify opportunities for improvement and develop new efficient procedures.
• Responsible for accuracy and timely inspection/calibration of monitoring and measuring devices.
• Keep up on standards, regulations/laws, issues, with respect to product (service) quality. Maintain current knowledge of FDA and other applicable foreign country regulations, legislation, best practices, and guidelines related to QA/RA.
• Monitor changes to applicable laws and regulations, identify impact to the business, and in collaboration with other stakeholders, develop response strategies and/or a work plan and complete according to deadline.
• Manage key quality and regulatory affairs initiatives to drive continuous improvement.
• Track, record, and maintain accurate quality data/documentation and perform statistical analysis.
• Effectively and efficiently document and investigate customer complaints, root cause analysis, implement corrective actions, and perform effectiveness checks.
• Educate staff in proper adherence to current quality procedures / processes.
• Communicate with suppliers and vendors to resolve quality issues.
• Maintain FDA regulatory compliance for regulated manufactured products, including registrations, listings, 510(k) submissions, letters to file, labeling, UDI, and other requirements.
• Provide leadership, guidance, and oversight to product quality teams, and other employees with responsibilities related to regulated products.
• Promote audit readiness, prepare quality teams for audits by external bodies, including FDA and BSI, and facilitate audits as needed.
• Prepare reports and respond to regulatory body enforcement inquiries by FDA or other foreign governments.
• Research, recommend, and implement best practices, and contribute to both the strategic and operational functions of the team.

Qualifications:

• Bachelor’s degree in business, engineering, or related field preferred.
• 5+ years’ experience in manufacturing and quality required. 3+ years’ experience in the medical device manufacturing industry with emphasis on quality assurance/quality control program management preferred.
• In depth understanding of quality procedures and ISO 9001/13485 compliance.
• Experience with lean manufacturing principles.
• Detail-oriented and a results driven approach.
• Working knowledge of data analysis/statistical methods.

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