Job Responsibilities : Staff Quality Engineer
Salary : $107000 per year
Company : Johnson & Johnson
Location : Remote US
Cerenovus part of the Johnson & Johnson Medical Devices Companies is recruiting for a Staff Supplier Quality Engineer located in Fremont CA. The primary location is Fremont CA USA; some consideration may be given on a case-by-case basis to candidates located near a Cerenovus site in Irvine CA Juarez Mexico Miami FL Raynham or Bridgewater MA or to remote candidates located within the United States
Every six seconds someone dies from a stroke. Stroke can be caused either by a clot obstructing the flow of blood to the brain (ischemic stroke) or by a blood vessel rupturing and preventing blood flow to the brain (hemorrhagic stroke). CERENOVUS is committed to changing the trajectory of stroke by providing physicians with innovative technologies to push the boundaries of what’s possible in neurovascular intervention. CERENOVUS offers a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke.
The staff supplier quality engineer will participate support and lead activities related to suppliers of raw materials components finished devices and services for the inspection of incoming materials implementation of corrective/preventive actions validations certifications qualifications and any project related to quality improvements.
- Supports different business units on the company following up on situations related to supplier quality.
- Support the incoming inspection group (technician team lead supervisor etc.) on the decision-making process and follow up of material nonconformance with suppliers.
- Responsible to coordinate supplier investigations related to material non-conformances.
- Participate in the investigation process and risk analysis of non-conformances caused by supplier.
- Works directly with suppliers and external manufacturers to ensure the products and services received meet requirements and/or specifications.
- Responsible for approving and/or escalating deviations on product specifications or processes from suppliers.
- Responsible for generating corrective and preventive actions to suppliers and verification of the effectiveness of such actions for approval and closure.
- Collect and distribute supplier performance data.
- Support suppliers on the implementation of improvement plans (example SPC Gage R&R etc)
- Support and lead initiatives to improve supplier’s performance in order to certify them or reduce receiving inspection activities.
- Participate in the analysis of complaints related to suppliers.
- Interact with other groups (Sourcing R&D LCM Engineering etc) for the process of supplier selection.
- Visit and evaluate suppliers thru audits or technical assessments.
- Develop and implement improvement programs for suppliers.
- Support the Quality Audit group providing quality metrics and supplier performance data
- Participate and support the introduction of new products in relation to new components or finished devices provided by suppliers.
- Supports the qualification validation and certification of supplier’s inspections methods and equipment.
- Responsible for the generation or updates to Supplier Quality Agreements.
- Participate with other functional groups and support activities related to changes requested by or to suppliers.
- Responsible to review create and approve changes to company procedures work instructions forms inspection reports and other related controlled documentation.
- Complete all training on time assigned by the quality compliance department.
- Responsible for follow ups implementation and closure of company corrective and preventive actions either internal or external.
- Attend and participate in quality metric reviews.
- Participate in different projects like Kaizen PE (GB/BB) and lean.
- Responsible for communicating business related issues or opportunities to next management level.
- Responsible for ensuring personal and Company compliance with all International Federal State local and company regulations requirements policies and procedures
- Performs other duties assigned as needed
- A minimum of a bachelor’s degree in an engineering discipline is required
Required Skills and Experience:
- 5+ years of experience in Quality Assurance working with suppliers within a relative industry
- Strong knowledge on corrective and preventive action systems (CAPA).
- Basic knowledge on statistical analysis and problem-solving techniques.
- Basic knowledge of project management tools.
- Strong understanding of GMP QSR .ISO 13485 requirements.
- Experienced with validation certification and auditing of suppliers.
- Understands specification drawings and departmental procedures.
- Knowledge of document control systems preferably ADAPTIV and JDE.
- Working knowledge of applicable requirements related to the MDSAP jurisdictions
- Understands six sigma tools
- Works under minimum supervision and takes self-directed action.
- Ability to take actions as needed based on J&J Credo.
- Ability to develop and implement quality standards.
- Effective verbal and written communication skills.
Preferred Skills and Experience:
- ASQ (or other) certified in Quality Engineering and/or Quality Auditor
- Green Belt or higher certification
- Experience implementing project management tools
- This position will be based in Fremont CA and may require up to 20% travel both international and domestic.
- Some consideration may be given on a case-by-case basis to candidates located near a Cerenovus site in Irvine CA Juarez Mexico Miami FL Raynham or Bridgewater MA or to remote candidates located within the United States
- An internal pre-identified candidate for consideration has been identified. However all applications will be considered
At Johnson & Johnson we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies we empower the physical mental emotional and financial health of our employees and the ones they love. As such candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees their families and the communities in which we live and work.
For more information on how we support the whole health of our employees throughout their wellness career and life journey please visit www.careers.jnj.com.
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.
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Medical Device Business Services Inc (6029)