Job Description

Responsible for directing, planning, organizing and controlling the processes, procedures, policies and activities for the assurance of the quality of the products according to the guidelines established by the clients and in compliance with the ISO 13485, reporting to Director Quality and Regulatory Affairs.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Plan and implement programs that ensure quality according to the requirements and guidelines of customers and in compliance with quality standards.

• Implements and drives the culture of continuous improvement.

• Manage the preparation, updating in the system of quality documentation, basing the processes on the standard of ISO 9001: 2015 and ISO 13485:2016 and FDA.

• Maintain daily communication with the Departments to follow the established processes and together take actions for the improvement or problems solution detected in the product or in the processes.

• Responsible to follow up and ensure that the personnel of the Department under her responsibility have the proper training to performance the job duties.

• Ensures adequate operational quality controls are developed to incorpórate customer and regulatory requirements.

• Implements the risk based approach to the site QMS and operations.

• Regulatory ensure manufactured products are appropriately licensed, produced and marketed.

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Qualifications

• Bachelor's degree, with a minimum of 5 years in relatable work experience required.
• Minimum 2 years of supervisory experience.
• Excellent oral and written communication
• Strong knowledge in ISO 13485 and 21 CFR82
• Strong management and communication skills
• Skills to make presentations to top management
• The incumbent is required to demonstrate a positive attitude on a consistent basis when working with others.
• Ability to work in matrix management and able to work collaboratively and cross-functionally as well as across the organization.
• Broad understanding of manufacturing processes.
• Strong organizational and communication skills.
• Ability to conduct training and present material to a wide range of audiences.
• Problem solving ability through technical knowledge.
• Must be able to influence others at all levels of the organization.
• Must possess excellent computer skills, i.e.: Microsoft Office including Excel, Word and Power Point.
• JD Edwards or an ERP system experience is a plus.
• The incumbent must demonstrate and promote teamwork on a consistent basis within the assigned department as well as across functional lines of operations effectively maintaining close communication with all required employees. __
• Must be confident in their ability to make decisions balancing business requirements with quality requirements and the associated risks.

Additional Information

The national pay range for this role is $68,600 to $112,900 / year. The pay range may be slightly lower or higher based on the geographic location of the hired employee. The actual pay offered may vary based upon, but not limited to: education, skills, experience, proficiency, performance, shift and location. In addition to base salary, depending on the role, the total compensation package may also include participation in a bonus, commission or incentive program. RRD offers benefits including medical, dental, and vision coverage, paid time off, disability insurance, 401(k) with match, life insurance and other voluntary supplemental insurance coverages, plus tuition assistance, maternity leave, adoption assistance, and employer/partner discounts.

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RRD is an Equal Opportunity Employer, including disability/veterans