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 Control
Job Category:
Professional
All Job Posting Locations:
Palm Beach Gardens, Florida, United States of America
Job Description:
We are searching for the best talent for Manager, Supply Chain Quality to join our DePuy Synthes Quality and Compliance organization located in Palm Beach Gardens, FL.
About Orthopaedics
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that's reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
The Manager, Supply Chain Quality will be accountable for the Operational Quality support of manufacturing and ancillary processes in the Palm Beach manufacturing site. This includes the execution and delivery of quality strategies for sustaining engineering and supporting the manufacturing of Power tools and medical equipment/robotics. This individual should be willing to make a significant contribution to a multi-disciplined team, be self-motivated to act, and have excellent written and verbal communication skills.
Key Responsibilities:
Partner with Operations, Regulatory, and Research to assure all sustaining engineering and Operation quality deliverables are met in accordance with all regulatory standards (e.g. FDA 21 CFR Part 820, ISO13485, EU MD Directive/Regulations, Japan JPAL, Canada CMDCAS, Brazil ANVISA, Australia TGA and all other applicable regulatory standards considering the countries/regions products are marketed.) within cost, quality, and schedule targets.
Manage the Operation Quality engineering resources and allocate projects as needed to support business objectives.
Excels as Supply Chain Quality processes such as CAPA, Change Management, and escalation.
Can discuss and defend documents and processes proficiently in front and back room during internal and external audits
Monitor quality metrics across the business unit to identify systemic product and process issues, assuring appropriate investigation, correction, and corrective and preventive action when needed.
Is able to identify and execute improvements on the Quality systems and execution thereof as it relate to improving the quality and compliance of the product, and the operational effectiveness.
Partner with R&D, Operations, and Regulatory to assure there is appropriate execution of risk management and design controls and process validation for new and existing products.
Know and follow all laws, standards, and policies that apply to one's job, and maintain the highest levels of professionalism, ethics, and compliance at all times.
Diligently participate in compliance program-related activities as denoted by leadership or our Compliance experts.
Promote and nurture the highest standards of professionalism, ethics, and compliance, and actively support our compliance program-related initiatives and activities.
Consistently enforce employee compliance, including attendance at training programs, and promptly report any non-compliance.
Develop team talent and competency.
Provide leadership in all areas of the Quality System beyond the support of production, such as product complaints, post market surveillance, nonconforming materials, risk management.
Provide leadership in the understanding of medical device regulations to other disciplines.
Communicate effectively at all levels, both within Quality and cross functionally with departments such as Product Development, Regulatory, Manufacturing, and Marketing.
Qualifications:
A minimum of a bachelor's degree is required. A degree in engineering and/or in a technical science is a plus. A master's degree is a plus.
A minimum of 8 years related working experience in a GMP and/or ISO regulated industry with a minimum of 3 years people management or project management experience is required.
Strong Quality engineering or Quality operations skills with a proven track record in design transfer Operation support, Process Validation, and product risk management is preferred.
Previous experience in a medical device or a healthcare discipline is strongly preferred.
Strong working knowledge of QSR (21 CFR 820), ISO (13485, 14971), and all country specific regulatory requirements is strongly preferred.
Knowledge of process and design excellence tools is strongly preferred. Certification is a plus.
Candidate should possess excellent problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations.
Candidate should have a proven track record implementing Quality System improvements to meet compliance and overall business goals. Proficiency with the Microsoft Office Suite is required.
Ability to effectively present complex information in a clear and concise manner is required.
Previous experience managing multiple projects is preferred.
Ability to clearly communicate to a variety of audiences, both big picture ideas as well as technical details is required.
Experience of developing concise and audience-focused communications, both written and for presentations is required.
Can manage through urgent unplanned topic with professionalism.
Excellent communication and interpersonal skills are required.
This position will be based in Palm Beach Gardens, FL and will require up to 10% travel, potentially including international travel.
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.
Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers .Internal employees contact AskGS to be directed to your accommodation resource.
LI-Hybrid
Required Skills:
Preferred Skills:
Coaching, Compliance Management, Human-Computer Relationships, Innovation, Performance Measurement, Process Improvements, Product Testing, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Standard Operating Procedure (SOP), Technical Credibility
