Johnson & Johnson Careers
Senior Engineer, Quality Compliance
Requisition ID: 0803180827
Advanced Sterilization Products is recruiting for a Senior Engineer, Quality Compliance 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 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 Senior Engineer, Quality Compliance will have responsibilities in planning, implementing, execution, standardizing, coordinating, and managing product related Escalations, Process improvement projects and managing the Quality Review Board process for the ASP business.
- Be responsible for establishing and maintaining policies and procedures to ensure compliance with local, state and federal environmental regulations and standards including compliance with all Food & Drug Administration (FDA), European Union Medical Device Regulations (EU MDR) and all other applicable global regulatory requirements.
- Be responsible for all Issue Escalation and Quality Review Board Coordination – coordinate investigation strategy with business stakeholders, coordinate periodic escalation meetings with the Risk Management Board (RMB) and/or Quality Review Board (QRB) teams, maintain meeting minutes, report status to internal departments and regulatory agencies, gather documentation of all activities and follow up to successful completion per established strategy.
- Be responsible to ensure critical/ significant quality issues impacting the product in the field are presented to the Quality Review Board for decision in containment/ corrections to be implemented for these in the field.
- Be responsible for reporting process metrics to appropriate review boards such as Management review, CAPA review board, periodic metrics reporting, etc.
- Implement/modify quality systems to address changing Regulations or industry standard, providing regulatory interpretation and guidance where required.
- Be responsible for communicating business related issues or opportunities to next management level.
- Follow all company safety policies and other safety precautions within the work area. Set standards for safe behavior. Recognize and reward safe behavior in others.
- Other responsibilities include, but are not limited to: coordinate and participate in special projects as assigned; May also provide support to other operating companies/franchises and 3rd parties as their issue escalation and/or recall coordinator.
- A Bachelor’s degree and a minimum of 4 years of experience in a regulated industry is required. Medical device manufacturing/industry experience is preferred.
- Prior experience in ISO 13485 and or QSR 820 FDA regulated environment is required.
- Experience leading CAPA team and investigations is preferred.
- Project Management experience is preferred.
- Six Sigma Green Belt certification is preferred.
- Excellent interpersonal relations and communication skills are required.
- Strong oral and written communications skills with ability to speak to broad, non-technical audiences that are both internal and external personnel is required.
- Experience preparing executive briefings and broad communications is required.
- Ability to make solid decisions that will effectively support the business and company policies is required.
- Advanced skills on Microsoft Office software, including PowerPoint, is required.
- Ability to work in fast paced environment and rapidly shifting priorities with business and financial acumen is required.
- This position will be located in Irvine, CA and may require up to 25% domestic travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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