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Quality Consulting Group, LLC is seeking a highly motivated and experienced Quality Systems Specialist to join our team. In this role, you will be responsible for ensuring the development and maintenance of quality programs, systems, processes, and procedures that meet regulatory requirements and industry standards.
Key Responsibilities:- Provide oversight for the development and maintenance of quality programs, systems, processes, and procedures.
- Ensure compliance with regulatory requirements and industry standards.
- Provide expertise and guidance in interpreting policies, regulations, and guidelines.
- Lead audit and inspection preparation, resolution of audit and inspection findings, and liaise with auditing groups and inspectors.
- Coordinate legal requests in support of government investigations or litigations.
- Ensure the quality assurance programs and policies are maintained and modified regularly.
- Facilitate uniform standards worldwide and enable best practice sharing.
- Bachelor's degree in Science, Engineering, or related field.
- Minimum of 2 years of Quality Management Systems and medical device experience.
- Strong understanding of global regulatory requirements for medical devices.
- Experience defining, driving, and implementing process improvement and functional excellence efforts.
- Strong organizational skills and time management skills.
- Ability to multitask, support multiple projects, function globally, prioritize, conduct team meetings, and meet project deadlines.
- Proven experience in achieving results through influence management and motivating teams.
- Good communication (oral and written), presentation, and interpersonal skills.
- Exhibits high degree of initiative and good judgment.
Quality Consulting Group, LLC is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.