Manager, Supplier Quality- Shockwave Medical - Santa Clara, California, United States of America

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 ...

Job description

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

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Manager of Supplier Quality – Shockwave Medical 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

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

Essential Job Functions

Supplier Management

• 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

Manufacturing Line Transfers

• 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

Manufacturing Support

• 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

Management

• 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

Qualifications

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

NOTE: This job description is not intended to be all-inclusive. Employees may perform other related duties as assigned or negotiated to meet the ongoing needs of the organization.

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  (ra-) or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Coaching, Controls Compliance, Critical Thinking, Engineering, Fact-Based Decision Making, Financial Competence, ISO 9001, Lean Supply Chain Management, Non-Conformance Reporting (NCR), Organizing, Process Improvements, Quality Control (QC), Quality Standards, Quality Systems Documentation, Quality Validation, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application

The anticipated base pay range for this position is :

$118, $203,550.00

Additional Description for Pay Transparency:

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: -