Sr. Director, Quality Operations and Supplier Quality-Shockwave
Johnson & JohnsonAbout the role
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:
Strategy & Corporate DevelopmentJob Sub Function:
Strategic Partnerships & AlliancesJob Category:
People LeaderAll Job Posting Locations:
Santa Clara, California, United States of AmericaJob Description:
Johnson & Johnson is hiring for a Sr. Director, Quality Operations and Supplier Quality for Shockwave Medical Inc. located in Santa Clara, CA.
The Sr. Director of Quality Operations and Supplier Quality provides leadership for the organization’s Quality Operations and Supplier Quality groups.
Participates in decisions on scope of work, risk management, length of tasks and compliance pathways, as well as optimization of manufacturing processes.
The Sr. Director participates in design changes to provide quality strategy and guidance for revised specifications and is expected to provide developmental and technical guidance to the team. The Sr. Director also develops and implements procedures and systems to assure Shockwave Medical 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
Essential Job Functions
• Quality Operations
o Directly responsible for ongoing management and improvements to the following Quality Operations activities:
Quality Control and Engineering support for manufacturing and operations
Incoming inspection and Final product acceptance activities
Complaints investigation
Document Control
Equipment Control
o Collaborate with R&D and Manufacturing engineering on process improvement projects.
o Interface with Design Assurance, R&D and Manufacturing to interpret Engineering requirements, drafting, reviewing and approving inspection and manufacturing related documentation.
o Support new product design transfer into manufacturing.
• Supplier Management
o 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.
o Identify supplier risks and work with cross-functional teams to prevent and/or resolve issues which could interrupt business continuity.
o Support component qualification projects in collaboration with key business partners and the supplier’s applicable functional groups.
• Manufacturing Line Transfers
o Define Quality requirements and plan tasks needed to transfer manufacturing lines or manufacturing processes to Contract Manufacturers or other SWMI sites.
o Support the cross-functional team by contributing to planning, allocating technical resources, assisting with technical issues, and providing guidance on transfers.
o Define processes to monitor product quality and production rates at CMs and to act when issues arise.
• Management
o Identify resource needs and hire as dictated by business needs.
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