Senior Quality Operations Manager

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

San Angelo, Texas, United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Senior Quality Operations Manager.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

Purpose:

Plans, coordinates and directs quality assurance programs designed to ensure the continuous production of products consistent with established standards through the following responsibilities, either personally or through subordinates.

At this level, the position has a major impact on business results and typically, management responsibility for the group of professionals under his/her charge.

This position will have responsibilities across the ETHICON and Cardiovascular and Specialty Solutions (CSS) Family of Companies of Johnson and Johnson) companies including a range of multiple product platforms such as General Surgical Devices, Sutures, ENT, Infection Prevention, Electrophysiology and Surgical and Non-Surgical Aesthetics.

You may be designated as a Management Representative.

You will be responsible for:

• Leads or supports quality improvement initiatives such as process and product characterizations leading to continuous improvement / cost.

• Reviews / analyzes the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and other improvement tools and programs.

• Conducts benchmarking to develop more effective methods to improve quality.

• Establishes and formulates quality metrics to maintain quality assurance objectives and alignment with plant objectives.

• Supports the development of quality engineering and quality compliance with appropriate skills for new product introduction, and product life cycle management.

• Promotes and supports the implementation of quality, product and process improvement projects.

• Reviews and approves engineering change orders (ECOs).

• Evaluates, monitors and analyzes quality costs to maintain a quality system in accordance with medical industry standards.

• Reviews / analyzes whether current products and processes (including actions or decisions taken) comply with standards, such as QSRs, ISO 13485, etc.

• Leads preparation activities for regulatory agency audits, including active participation as "SME" or "Escort" (e.g. FDA, JJRC, BSI, etc).

• Reviews and approves responses to internal or external audit observations to ensure compliance with internal procedures and applicable regulations.

• Establishes and properly maintains required documentation of quality assurance activities and/or quality systems.

• Ensures periodic line audits are conducted to evaluate GMPs, production controls, batch segregation and process audits in accordance with JJPS. Reviews results of area audits to ensure corrective and preventive actions are appropriate.

• Defines, monitors and manages the department's central budget/cost.

• New Product / Process Introduction

• Collaborates with NPI and the operations and engineering departments to develop, conduct and approve product and process validation strategies.

• Leads and attends NC Review meetings as a member of MRB.

• Reviews and approves investigations, bounding, documentation, review and approval of non-conformances (NCs), corrective and preventive actions (CAPAs), customer complaints and Escalation of quality issues as applicable.

• Responsible and owner of material identification, material segregation, cla