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QUALIFICATIONS / REQUIREMENTS:

• Bachelor’s Degree in Science, BS in Engineering preferred.
• A minimum 8 years of related experience in a regulated environment.
• 3+ years of supervisory experience.
• Experience in the Medical Device industry or medical field.

SKILLS:

• ASQ Certified Quality Auditor (CQA) preferred, or ISO Certified Lead Auditor preferred.
• Advanced computer skills and use of software application(s).
• Fully Bilingual (Spanish & English)
• Strong technical writing skills are required.
• Leadership and management skills.
• Interpretation and application of QSR and ISO Standards.
• Excellent communication and interpersonal relation skills.
• Statistical and analytical problem solving.

PURPOSE:

Under the direction of the Site Quality Lead and with the objective of maintaining high quality standards for the product manufacturing process and in compliance with regulatory requirements, provides leadership, technical support and direction to Plant Operations and Quality Assurance.
Directly supervises Quality Engineers (different levels/pay grades), Quality Team Leaders, Quality Technicians and/or non-exempts associates in day to day activities supporting manufacturing lines, operator certification program, incoming and finished goods inspections; all in accordance with applicable regulations. Provide support and expertise on problem solving, process improvements and in the usage of quality tools.

YOU WILL BE RESPONSIBLE FOR:

Under the direction of the Site Quality Lead and in alignment with all federal, state, and local laws and Johnson & Johnson corporate guidelines, your responsibilities will include:

• Manages the deployment and utilization of resources for tactical day to day work. This includes but not limited to working with Operations, Materials Management, Technical Operations and Quality Assurance to facilitate testing and release of finished goods product.
• Manages the testing and controlling of raw material, finished product quality and in process quality, assuring compliance with company standards and applicable regulations.
• Responsible for the evaluation and disposition of WIP and questionable raw materials.
• Advice and guide Operations on inspection and testing procedures, provide direction and recommendations when required.
• Fosters teamwork and supports total associate involvement.
• Assists the Site Quality Lead in the preparation of the Annual Department Budget.
• Resides as a backup to the Site Quality Lead for signature authority and meeting representation.
• Approves purchases and expense reports submitted by direct reports.
• Analyzes Plant reports for significant quality trends and reports conclusions.
• Supports Internal Regulatory Compliance Function as required.
• Monitors GXP activities across the campus.
• Participates in the developments of procedures, specifications, cost control planning, self-inspection methods and systems for QA. Enforces implements and follows up on all procedure and specifications.
• Approves specification and process changes per applicable procedures.
• Provides feedback to operations on problems related to quality and/or compliance.
• Supports investigations of non-conformances and associated corrective and preventive actions.
• Supports validations as required.
• Assists Site Quality Lead in the preparation of the Performance/Potential Appraisals for the Quality Operations related functions.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices, and that all resources needed to do so are available and in good condition, if applicable. Ensure QA Department comply with Department Spending and deliver Cost improvement Projects (CIP).
• Ensure talent development of direct reports, including but not limited to Certifications and Trainings.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned, as needed.