Quality & Regulatory; QA​/RA Manager

Exsurco Ohio
10804 Green Road
Wakeman, OH 44889, USA

• Developing and maintaining quality and regulatory systems and system elements in conformity with domestic medical device agency regulations and requirements.
• Achieve 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 changes.
• Meet quality assurance financial objectives by estimating requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.
• Have working knowledge of device and biologic frameworks Design Control and/or Quality by Design. Guide the team through phases, understand documentation and testing requirements, and maintain files.
• Participate 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
  • Managing UDI system access (e.g., GUDID, EUDAMED)
• Prepare 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.
• Update job knowledge by studying trends and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations (Med Con, ASQ, AAMI).
• Manage supplier controls through the Approved Supplier List (ASL) and conduct supplier audits.

• 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.

• 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 communication skills.
• Ability to exercise authority, manage conflict, and influence others positively.
• 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 system.
• Working knowledge of ERP & PLM systems.

• 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.

Equal Opportunity Employer
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