Johnson & Johnson Careers
Requisition ID: 0398180822
Advanced Sterilization Products is recruiting for a Complaints Specialist 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.
- Review and analyze assigned customer complaints; and proper investigate the complaint and contact the customer if necessary.
- Evaluate all information from a clinical and technical perspective to ensure appropriate Subject codes, Analysis, Investigation, Root Cause, and Quality Engineering review is documented prior to complaint closure.
- Ensure proper documentation and closure of each complaint in order to make and document sound regulatory reporting decisions/justifications for worldwide reporting.
- Develop, establish, prepare and distribute dashboards and reports to assure complaints are processed and coded in a timely manner.
- Develop a thorough understanding of the complaint database.
- Develop, prepare, and analyze reports for coded complaints on a weekly and monthly basis, as required.
- Escalate critical issues for proper disposition as necessary.
- Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies, Johnson & Johnson Environmental, Health & Safety Practices, and other applicable standards as pertains to medical devices.
- Be responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
- Performs other duties assigned as needed
- A BS in computer science, engineering, physical, biological, or natural sciences is required.
- A minimum of 1 year of quality, manufacturing, or regulatory experience in a medical device or other regulated industry is required.
- Must possess the basic understanding of engineering fundamentals.
- Good written and oral English communication skills.
- Must be computer literate.
- Continuous interaction with global groups and ability to collaborate with global customers is expected.
- Previous experience with complaints handling is preferred.
- This positing will be located in Irvine, CA and may require up to 15% domestic and/or international 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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