Johnson & Johnson Careers
QUALITY SOURCE MANAGER
Requisition ID: 1905746305W
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
The Global Job Posting policy promotes the dedication to the advancement and development of our employees. We invite you to read this posting and apply if you are passionate about the position and meet the requirements.
Biosense Webster, Inc. is recognized worldwide as a leader in the science behind the diagnosis and treatment of cardiac arrhythmias. Guided by the needs of electrophysiologists and cardiologists, Biosense Webster has pioneered innovative technological advancements for more than 30 years. Some might call this quite a heritage. At Biosense Webster, Inc., we say it's just the beginning. For more information, visit www.biosensewebster.com
Quality Source Manager
Reporting to the Director, Quality Source Direct Materials - Americas, the Manager Quality Source has primary responsibility to provide global Supplier Quality Assurance expertise, direction and mentorship in the development, implementation and continuous improvement of Source Quality programs associated with the management of Biosense Webster (BWI) Suppliers. This position will provide Source Quality support in line with established J&J MD, industry and regulatory standards (e.g. QSR, ISO, EN, and Medical Device Directive (MDD) requirements). He/She will develop and monitor quality systems to ensure that all Suppliers meet their quality objectives with regards to supplier, process and product controls.
You will be responsible of:
- Overall quality activities, including purchasing controls, associated with Suppliers.
- Leading development, continuous improvement and implementation of purchasing control processes for responsible Suppliers that meet regulatory requirements and align with J&J MD standards.
- Recruiting, developing and leading a high performing source quality team to achieve the group’s objectives, if applicable.
- Providing Source Quality Engineering support to Suppliers including inspection technique, product non-conformances, verification/validation activities, CAPA and change management.
- Ensuring effective and timely investigation and closure of all CAPA’s, Non-Conformances, complaints, product issues.
- Providing Supplier quality input to Franchise QS Management Reviews, quality/business reviews and product/process escalations.
- Supporting third party assessments at both Direct Material Suppliers and sub-tier suppliers.
- Providing Quality Leadership in support of Supplier Outsourcing programs and product transfers.
- Partnering with site Management teams to meet site Source Quality related objectives.
- Driving a standardised approach by chairing Supplier Management Committee meetings, Supplier Performance Monitoring and Joint Supplier Collaboration sessions.
- Leading the approved supplier list for responsible sites.
- Maintaining and controling Purchasing Control SOPs in compliance with J&J requirements and applicable regulations.
- Maintaining supplier management documentation and records to ensure they are complete and current.
- Conducting tactical planning and collaborating with different functions to establish quality strategies, business priorities and resource allocation, as well as driving continuous improvement initiatives.
- Designing and validating Quality System processes where appropriate.
- Participating in design evaluations where appropriate.
- Resolving problems and eliminating constraints to ensure project and supply targets are met.
- Generating Quality metrics on supplier performance and establish measures to monitor quality.
Requirements and Education:
- A minimum of a bachelor’s degree in Engineering, an Applied Science or a related technical or quality field.
- An Advanced degree in engineering/scientific or management discipline is preferred.
- 6+ years of related experience in a medical device or regulated industry is required.
- Previous work experience with Suppliers is preferred.
- Fluent English.
- 30% domestic/international travel availability.
Knowledge and Skill Sets:
- Demonstrated knowledge of business impact of compliance issues and risk management.
- Experience in leadership roles involving project management, problem-solving and technical projects.
- Excellent oral and written communication skills, facilitation, presentation, negotiation, and influencing skills.
- Computer-literate in the use of software applications including Microsoft Office (Word, Excel, PowerPoint).
- Ability to collaborate with all levels of management in matrixed team environment.
- General understanding of regulatory compliance requirements (QSR, MDD, ISO 9001, ISO13485, ISO 14971 and other international standards).
- ASQ Certification: Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), Certified Supplier Quality Professional (CSQP), and/or Certified Six Sigma Black Belt (CSSBB) preferred.
- J&J Flawless Project Execution (FPX) or Project Management Professional (PMP) Certification, and/or J&J Lean/Six Sigma Certification preferred.
- People management/talent development experience, hands on strategy development and deployment experience is preferred.
Primary Location: Biosense Webster
Reporting to: Director MD Quality Direct Material Americas
Cordis de Mexico S.A. de C.V. (8286)