Staff Quality Systems Specialist
4 days ago
Johnson & Johnson is seeking a highly skilled Staff Quality Systems Specialist to join our team. This role will be responsible for leading the monitoring, assessment, and implementation of standards and regulations in the Quality Systems organization.
Key Responsibilities:- Manage external standards and regulations gap assessment and gap closure activities.
- Identify Subject Matter Experts (SMEs) for new and revised external standards and regulations.
- Assign, review, and approve external standards and regulations assessments.
- Assist SMEs with the external standards and regulations assessment process.
- Serve as lead SME in completing gap assessments for Quality System related external standards and regulations.
- Track the status of SME assignments relative to due dates, providing reminders and assisting with extensions, where appropriate.
- Monitor external standards and regulations for changes.
- Maintain the Master Standards and Regulations List for Abiomed.
- Serve as a local SME on the standards and regulations process for Abiomed in audits.
- Maintain lists in external standards and regulations monitoring services.
- Prepare standards and regulations content for Quality Systems Management Review and present at the meeting, if requested.
- Assist with sourcing, assisting, and tracking Abiomed SMEs for J&J internal standards.
- University/Bachelor's degree is required; a degree concentration in Math, Science, Business, Engineering, or other relevant subject area will be an asset.
- Minimum of four to six (4-6) years of related experience.
- Experience in Quality Systems, Quality Engineering, Quality Assurance, or other technical work experience.
- Minimum of five (5) years of experience in an FDA regulated industry.
- Ability to work independently and as part of a team.
- Up to 10% travel, domestic and internationally required.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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