JOB SUMMARY Working without significant direction, supports Quality Management through advanced level activities requiring broad business knowledge.
Performs a broad range of tasks which may include research, architecture planning, analysis, design, validation, maintenance, support, training, and implementation of Quality Systems, Policies, and Procedures.
ESSENTIAL DUTIES Works with quality management, manufacturing, engineering, and other functional groups on regulatory and quality system compliance issues.
Develops or participates in the development of solutions to problems of intermediate to high complexity.
Performs varied quality/regulatory activities such as developing and implementing plans and procedures to comply with applicable local and international regulations.
Interprets, executes, and recommends modifications to operating policies/procedures where appropriate.
Modifies, updates, and executes established programs to achieve and maintain a state of compliance.
Contributes to or leads projects for the timely completion of corrective actions.
Supports the implementation and maintenance of the Quality System.
Provides support to the internal and external audit program.
Leads and participates in continuous improvement.
Document quality issues, execute root cause investigations and implement actions to address the issues.
- Ensure great customer service at all levels.
OTHER DUTIES AND RESPONSIBILITIES May assist or lead in identification, creation, implementation, and maintenance of training for QMS policies and procedures.
May prepare and deliver presentations to management team.
May direct supervision of professional and quality support staff including the review, evaluation, and development of reporting associates.
- May plan workloads, allocating tasks and monitoring progress against targets
**Requisitos**:
REQUIREMENTS Bachelor's degree in Engineering.
Minimum 5 years of prior experience in medical devices industries.
Minimum 2 years in Quality operations experience is desirable.
Advanced English skills.
Strong knowledge of FDA and ISO regulations preferred.