Manager, Supplier Quality- Shockwave Medical

Johnson & Johnson•Santa Clara, CA

20h

About The Position

Johnson & Johnson is hiring for a Manager of Supplier Quality – Shockwave Medica l to join our team located in Santa Clara, CA. 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/. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview The Manager of Supplier Quality is responsible for the administration, supervision, and development of the Supplier Quality group. They are expected to provide leadership for the organization’s quality engineering, quality system, and risk management program. They define processes and systems, and implement procedures to ensure that the organization complies with applicable regulatory standards such as: ISO 13485 – Medical Devices – Quality Management Systems ISO 14971 – Medical Devices – Application of Risk to Medical Devices 21 CFR Part 820 – Quality System Regulation 21 CFR Part 803 – Medical Device Reporting FDA Current Good Manufacturing Practices (CGMPs) EU MDR – European Medical Device Regulation (MDR) Council of the European Communities Directive 93/42/EEC – Medical Device Directive MDSAP and other relevant geography regulations CMDR – Canadian Medical Devices Regulations

Requirements

BS degree in a related engineering discipline and 10+ years of related experience, or MS degree in a related engineering discipline and 8+ years of related experience
2+ years of experience managing others or equivalent experience
Strong understanding of cGMP, FDA 820 QSR, ISO 13485
Ability to effectively supervise, manage, and develop teams
Ability to work in a fast-paced environment while managing multiple priorities
Ability to initiate and/or lead projects and successfully drive projects to completion
Ability to make decisions with minimal information with an understanding of risks and outcomes
Strong analytical and problem-solving skills
Strong communication skills (written, verbal)
Ability to travel up to 25% of the time

Nice To Haves

Prior experience in product / manufacturing line transfers is a plus
Relevant certifications (e.g.: Lead Auditor, Six Sigma, Project Management, CQE) are a plus

Responsibilities

Define and implement processes which meet regulatory requirements pertaining to the selection, evaluation, and monitoring of suppliers
Create and/or maintain procedures to ensure that the organization complies with applicable regulatory standards
Identify supplier risks and work with cross-functional teams to prevent and/or resolve issues which could interrupt business continuity
Communicate critical issues to upper management and escalate accordingly
Define KPIs and metrics for Supplier Quality and create/define systems to support the efficient collection and analysis of data for such KPIs and metrics
Plan, manage, and oversee the assessment and implementation of process changes (eg: capacity expansions, equipment, supply chain) at suppliers or at SWMI
Support component qualification projects in collaboration with key business partners and the supplier’s applicable functional groups
Oversee and manage the execution of Supplier Quality responsibilities such as Supplier Audits, Supplier Qualifications, Supplier Corrective Actions (SCARs), Supplier Change Assessments (SCAs), Non-conformance Reports (NCRs) for raw materials/components
Define Quality requirements and plan tasks needed to transfer manufacturing lines or manufacturing processes to Contract Manufacturers or other SWMI sites
Support the cross-functional team by contributing to planning, allocating technical resources, assisting with technical issues, and providing guidance on transfers
Define processes to monitor product quality and production rates at CMs and to act when issues arise which could interrupt business continuity
Oversee and manage the execution of Quality tasks to support Operations such as Corrective and Preventive Actions (CAPAs), Document Change Orders (DCOs), Non-conforming Reports (NCRs)
Collaborate with Manufacturing Engineering on process improvement projects
Participate in decision-making at Material Review Board (MRB) meetings
Interface with R&D, Quality Design Assurance and Operations to interpret requirements and to draft, review, and approve specification for products, processes, and components
Identify resource needs and hire personnel as dictated by business needs
Train, mentor, coach, and lead Supplier Quality Engineers
Define department and individual contributor goals which align with the organization
Directly manage and track overall department and individual contributor progress
Allocate SQE resources to cross-functional projects and manage fluctuating priorities
Collaborate cross-functionally in the interpretation of regulatory and engineering requirements, and educate and influence others on those requirements
Stay current with regulatory changes through industry publications, seminars, and participation in trade organizations
Integrates Johnson & Johnson’s Credo and Leadership Imperatives into team goals and decision-making.
Other duties as assigned

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits