Quality Assurance and Regulatory Affairs Manager

Quality Assurance / Regulatory Affairs Manager

Job Summary :

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 :

Reasonable accommodations may be made to enable individuals with disabilities to perform the 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.

Conduct periodic management review meetings.

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.
• Create and maintain regular lines of communication with other department managers to promote quality awareness, regulatory partnership, and harmonization of quality processes.
• Collaborate with other managers to develop, implement, monitor, and track standardized quality training for employees.
• 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.
• Provide consultative guidance to other managers, quality personnel and other stakeholders of QA / RA issues.
• Research, recommend, and implement best practices, and contribute to both the strategic and operational functions of the team

Additional Responsibilities :

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.

Duties, responsibilities and activities may change at any time with or without notice.

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.

Desired Competencies :

Any combination of education and experience that has led to the acquisition of the knowledge, skills, and abilities as indicated above.

Strong operational and project management skills.

Demonstrated team building and leadership skills.

Solid understanding of engineering issues / needs, financial, sales, and marketing as related to quality / regulatory requirements during product design and development.

Self-motivated with excellent organizational and time management skills.

Proficient use of a personal computer, office software systems, and other equipment associated with a general office environment (copier, telephone, fax, etc.).

Must be able to communicate efficiently and effectively in both written and verbal form.

Must maintain confidentiality of work related information and materials.

Must establish and maintain effective working relationships.

Ability to stay on task and work effectively with no supervision