Quality & Regulatory (QA/RA) Manager

POSITION SUMMARY: 

The QA/RA Manager provides leadership, direction and hands-on involvement with Regulatory Affairs and Quality Management Systems. You will be able to influence the businesses performance by maintaining compliance with domestic quality system as required for Medical Device Manufacturers involved with Clean Room Operations, and through support of other functional departments or product staff in supplying quality and regulatory input and feedback. Using prior education and work experience knowledge, helps assure compliance with overall regularity requirements, site, and UDI requirements.

RESPONSIBILITIES:

 The duties & responsibilities of the QA/RA Manager include Regulatory Activities, Corporate Quality, oversight of Plant Quality, Microbiology/Sterilization and Document Control, but are not necessarily limited to the following responsibilities:

• Developing and maintaining quality and regulatory systems and system elements in conformity with domestic medical device agency regulations and requirements.
• Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing regulatory and quality activities, initiating, and executing audits (internal and external); determining system improvements; implementing change.
• Meets quality assurance financial objectives by estimating requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.
• Working knowledge of device and biologic frameworks Design Control and/or Quality by Design. Must be able to guide team through phases, understand documentation and testing requirements, and maintain files.
• Participating in the development and execution of installation, operational and performance qualifications of equipment, (IQ, OQ and PQ) including the clean room itself.
• Act as UDI information coordinator, including:
  • Managing data within the UDI spreadsheet, including updates due to product changes
  • Completing UDI system data entry throughout the product lifecycle (e.g., GUDID Label Data Entry User, EUDAMED)
  • Responding to regulatory agency questions with support from the Quality/Regulatory Director
  • Manage UDI system access (e.g., GUDID, EUDAMED)
• Prepares quality documentation (ERTs, CRTs and Management Review) and reports by collecting, analyzing, and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
• Updates job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations (Med Con, ASQ, AAMI).
• Manages supplier controls through the Approved Supplier List (ASL) and conducts supplier audits.

 Skills/Qualifications:

 EDUCATION AND EXPERIENCE

• BS or BA degree in a life science, or similar with advanced experience in QA/RA areas or related training required
• 5 – 7 years’ experience in QA and Regulatory Affairs Knowledge and direct working experience with ISO and FDA GMPs Regulations.
• Advanced training and certifications related to quality assurance a plus.

 SKILLS, SPECIALIZED KNOWLEDGE AND ABILITIES

• Demonstrated success in leading and developing a collaborative team is essential.
• Ability to work with Government officials and FDA/ISO auditors.
• Effective project management skills, excellent interpersonal, verbal, and written communications skills.
• The ability to exercise authority, manage conflict, and influence others to a point of view in a positive way.
• Customer, team-focused, proactive, and seeks continuous improvement.
• Ability to remain calm and composed in stressful situations.
• Ability to work with and communicate well with other groups outside of QA/RA.
• Ability to lead meetings and small groups.
• Working knowledge of Microsoft Word, Excel, and Master Control or a Cloud based quality systems.
• Working knowledge of ERP & PLM systems

 PERSONAL CHARACTERISTICS:

Behave Ethically:  Understand ethical behavior and business practices and ensure that own behavior and the behavior of others is consistent with these standards and aligns with the values of the organization.

Communicate Effectively:  Speak, listen and write in a clear, thorough and timely manner using appropriate and effective communication tools and techniques.

Creativity/Innovation:  Develop new and unique ways to improve function efficiency and performance.

Foster Teamwork:  Work cooperatively and effectively with others to set goals, resolve problems, and make decisions that enhance process effectiveness.