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Job Description
- Plans and executes continuous development of quality system projects from planning through launch and maintenance, according to project plan.
- Develop and implement strategies and processes to maintain compliance with applicable regulations and standards.
- Maintain proficiency on quality and regulatory requirements.
- Provide guidance on regulations and policies to project teams.
- Actively engage internal and extended project team members.
- Develop and manage the project plan including but not limited to goals, strategy, identification of risks, analysis of development alternatives, and communication with the team.
- Update manager and business process owners on project status.
- Define, implement, and maintain internal audit processes and activities.
- May act as Lead Auditor for Quality System Internal Audits
- May act as Internal Audit Quality Administrator
- Support external audits and audit responses.
- Implement Non conformance Corrections and Corrective & Preventive actions as required.
- Has the responsibility and authority to perform required tasks to ensure all provisions of the quality system are met.
Job Requirements
- 10-12 years of experience.
- Previous experience with project management of activities related, but not limited to: global regulations, quality procedure development, audit facilitation, implementation of systemic compliance solutions, documentation approval, and internal communications is strongly preferred.
- Previous experience with internal auditing to ISO9001 and ISO27001 requirements is preferred.
- Strong interpersonal and presentation skills for interacting with management team.
- Ability to work in a team environment
- Ability to deal with ambiguity and change
- Commitment to excellence and high standards.
- Excellent written and oral communication skills.
- Ability to work with all levels of management.
- Strong organizational, problem-solving, and analytical skills.
- Ability to manage priorities and workflow.
- Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
- Acute attention to detail.
- Demonstrated ability to plan and organize projects.
- Proven ability to handle single projects and meet deadlines.
- Good judgment with the ability to make timely and sound decisions.
- Creative, flexible, and innovative team player.
- Working knowledge and understanding of the basic principles, theories, concepts, and practices in the applicable area of regulatory/quality specialization.
- Bachelor's degree in Engineering or related discipline.
- Project Management Professional, and/or ISO Lead Auditor Certifications are a plus.
