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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 Systems

Job Category:

Professional

All Job Posting Locations:

Guaynabo, Puerto Rico, 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 Sr Manager, Supply Chain Quality EndoMech and Energy to be in Guaynabo, Puerto Rico.

The Sr Manager, Supply Chain Quality EndoMech and Energy will support the Ethicon-Endo Surgery LLC (EES) Supply Chain Quality organization to transform the way we serve customers and patients with high-quality and compliant products each and every day into the future.

The Senior Manager is responsible to maintain a connection with the Quality Regulatory and Compliance and the Quality Excellence teams through strategies that drive continuous quality excellence, maintain supply chain compliance, providing Energy and Endomechanical platforms (Ethicon Endo-Surgery) support and addressing customer facing needs. In addition, this leader will identify and implement key capabilities that will make Quality a competitive advantage by unlocking productivity and accelerating execution.

This role will be responsible for the management of the Quality Management System (QMS) of Ethicon-Endo Surgery LLC (EES LLC), Guaynabo site, and manage audits/inspections from Health Authorities, Notified Bodies, Johnson & Johnson, and customers and serve as the deputy Person of Responsible Regulatory Compliance (PRRC) for EES LLC legal manufacturer as per the EU MDR regulation.

Key responsibilities:

+ Has oversight of the execution of the Quality Systems activities for EES LLC products. These activities include but are not limited to CAPA, Non -conformances, Management Review, Internal Audit, Records Management, Document/Procedures review/approval and Quality Agreements in Compliance with applicable regulations and procedures.

+ Assures systems are compliant to all applicable US and International Standards and Regulations such as GLP, GCP, GMP/QSR, MDD / EU MDR, EN (European Norm, harmonized standard for quality assurance in medical device manufacture), Canadian Medical Device Regulations, Japan PAL and ISO13485.

+ Provides pre-and post-inspection support for FDA, Notified Body, and other Health Authority inspections, which may include inspection readiness activities, direct interaction with inspectors/auditors, and establishing response strategies to address observations/nonconformances.

+ Provides strategic and operational support to the Senior Director, Supply Chain Quality (SCQ) for the EES franchise and serves as delegate.

+ Acts as the deputy Person of Responsible Regulatory Compliance (PRRC) for EES LLC legal manufacturer as per EU MDR regulation. Refer to supplemental Job Description100753348 for Management Representative and PRRC responsibilities.

+ Provides routine communication, performance results and updates to site management, franchise and supply chain leadership regarding quality systems trends, initiatives and risks.

+ Collaborates with other Quality and Supply Chain partners in identifying and deploying platform end to end strategies associated with Service, Quality, Compliance and People enabling platform Strategic Plans and Long -Range Financial Planning.

+ Support the legal manufacturer strategies and regulatory requirements such as document approval for EES LLC products, Certificates of Analysis, Manufacturing Declarations, regulatory requests, among others.

+ Serves as the Records Retention Manager for the Guaynabo site.

+ Attends meetings, such as Gate Review, Risk Management Board, Management Reviews, among others, in representation of the legal manufacturer EES LLC, as applicable.

Qualifications

Education:

+ A minimum of a Bachelor’s degree in a Life Science, Engineering, Physical Science or equivalent is required.

Experience/Skills

Required:

+ Eight plus (8+) years of related experience and/or training in a regulated environment (medical device and/or pharmaceutical preferred).

+ Front-room role experience with FDA (or similar) and Notified Body inspections.

+ Demonstrated knowledge of ISO 13485, 21 CFR Part 820, EU MDD/MDR, and MDSAP.

+ Demonstrated experience managing Quality Systems as well as experience with regulatory requirements.

+ Demonstrated knowledge of manufacturing/quality principles and practices.

+ Strong verbal and written communication to all levels of the organization, influencing, and leadership skills.

+ Ability to build strategic partnerships to accomplish company goals in a team environment.

+ Ability to handle multiple projects simultaneously and the judgement to discern and resolve major quality issues.

+ Fully Bilingual, Spanish and English, written and verbal.

Preferred:

+ ASQ or Industry recognized Certification.

Other:

+ This position may require up to a 20% of domestic and/or international travel.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

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