Johnson & Johnson Careers
Staff Quality Engineer, Supplier Quality
Requisition ID: 0988180830
Advanced Sterilization Products is recruiting for a Staff Quality Engineer, Supplier Quality to be located in Irvine, CA.
Healthcare-associated infections (HAIs) have a devastating personal and economic impact, claiming the lives of 99,000 people in the U.S. each year at a cost of up to $45 billion. Ensuring that all surgical devices are properly sterilized is one-way healthcare workers can help reduce the incidences of HAIs, and Advanced Sterilization Products (ASP) has been partnering with hospitals for decades to safeguard patient health and safety. ASP has a strong track record of designing and delivering innovative infection-prevention solutions, from low-temperature steam sterilization to high-level disinfection, and is a global market leader setting the standard in sterilization.
Johnson & Johnson announced that it has received a binding offer from Fortive Corporation to acquire Advanced Sterilization Products (ASP). If the offer is accepted, the proposed transaction would be expected to close no later than early 2019, subject to customary closing conditions and regulatory approvals. Should you receive and accept an offer for this position, upon completion of the transaction, your employment with ASP will transfer to Fortive according to local law and will be governed by Fortive’s employment processes, programs, policies and benefits plans.
You, the Staff Quality Engineer will establish and maintain quality assurance standards which adhere to Quality System Requirements (21 CFR 820) and ISO regulations (ISO 13485) to ensure products and services are provided to customer requirements.
- Be responsible for the quality and regulatory compliance of products manufactured at Suppliers and External Manufacturers.
- Monitor quality performance of suppliers and external manufacturer’s, establish inspection and test methods for assigned product lines manufactured at suppliers, participate in technical assessments & quality system audits of suppliers to identify potential areas of risks, process variability and address root causes.
- Using Six Sigma methodology capable to perform process variability studies, Risk analysis, test method variability and establish sampling plans.
- Lead or support teams to investigate quality issues (Failure investigations) to resolve complaints, non-conforming products and CAPA.
- Lead the preparation of validation and qualification protocols and support the execution of process / product qualifications &validations (IQ, OQ, PQ) projects.
- Provide support to develop and maintain good documentation to support the Validation Process, specifications, manufacturing and test procedures.
- Participate and collaborate with Supply chain, R&D Engineering, Operations Engineering and Manufacturing to identify potential areas of process variability, address root causes and implement improvements.
- Participates in preparation of Process/Design Failure Mode and Effects Analysis (PFMEA / DFMEA).
- Participate in new product development team activities in the development and qualification of suppliers.
- A bachelor’s degree in engineering and a minimum of 6 years of relevant work experience is required.
- Prior experience within an electro-mechanical environment as well as previous medical device experience is preferred.
- A Six Sigma Green belt /Black belt certification is preferred.
- Prior knowledge of medical device regulations such as 21 CFR 820 and ISO 13485 is preferred.
- Experience with process validations and the use/application of statistical tools is preferred
- Candidates who have prior experience in (sampling, design of experiments, process capability analysis) as well as the capability to review manufacturing processes (Control plan, process control and quality control) will be given higher considerations
- This position will be located in Irvine, CA and may require up to 30% domestic and/or international travel.
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.
Advanced Sterilization Products (ASP)