STAFF CSS, LEAD-FIELD CORRECTIVE ACTION Job

Job description

STAFF CSS, LEAD-FIELD CORRECTIVE ACTION-8468150611DescriptionThe Lead Staff CSS of Field Corrective Actions will have responsibilities for one of the Cardiovascular and Specialty Solution Companies (Acclarent, Biosense Webster, and Mentor – Johnson and Johnson Family of Companies) which may include a span of multiple product platforms such as ENT, Infection Prevention, Electrophysiology and Surgical and Non-Surgical Aesthetics.
Acclarent,Inc. is a medical device company, whose singular focus is to free patients to live better lives by designing, developing, and commercializing medical devices that address conditions affecting the ear, nose, and throat.
Biosense Webster, Inc. is the global leader in the science of diagnosing and treating heart rhythm disorders and one of the fastest-growing businesses within Johnson & Johnson.
Mentor Worldwide LLC is a leading supplier of medical products for the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow patients to improve their quality of life through breast, body and facial aesthetics.
SUMMARY OF THE JOBThis position will have responsibilities in planning, implementing, execution, standardizing, coordinating, and managing product related Escalations to all Field Corrective Actions (FCA) across CSS.ESSENTIAL DUTIES AND RESPONSIBILITIESUnder (e.g. limited supervision, general direction, etc.) and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: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) and European Union Medical Device Directives (MOD) as well as all other applicable global regulatory requirements. Schedule, lead, coordinate and prepare for FCA Teams and Meetings by gathering all required information from all sites/required groups, performing dry runs, managing the process, preparing minutes, following up on action items and maintaining records. Responsible for establishing and maintaining policies and procedures to ensure compliance with local, state, and federal environmental regulations and standards. Manage, maintain, and improve and standardize FCA processes to ensure compliance with FDA regulations and ISO Standards. Schedule, coordinate, follow-up on all FCA action items resulted from FCA Team meetings and maintain related files.
Implement/modify quality systems to address changing Regulations or industry standard, providing regulatory interpretation and guidance where required. Advise staff to help meet established schedules or resolve technical operations problems.
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. Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Performs other duties assigned as neededQualificationsREQUIRED EDUCATION/TRAINING and/or EXPERIENCE:A Bachelor’s degree is required. 3+ years’ experience in related experience with a minimum of 2 years direct experience in coordinating effective FCA’s in medical device industry is requied.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:A thorough knowledge of Quality, Regulatory compliance, and operations systems and processes, including GMP and QSR requirements for medical devices is required. Advanced knowledge of IS013485:2003, FDA's QSRs, EU's MDD, Canadian Regulations is a must. The ability to use broad knowledge of regulatory, technical, and business requirements to effectively lead, implement, and manage various quality systems and compliance is required. Excellent interpersonal skills, negotiation and influencing 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 are required.
Skills pertinent to preparing executive briefings and broad communications are required. Strong Computer Skills are required.
The ability to make solid decisions that will effectively support the business and company policies is required. The ability to work in fast paced environment and rapidly shifting priorities with business and financial acumen. Highest ethical standards and integrity.
This position is located in Irvine, CA. This position requires may require up to 20% travel.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NAPrimary Location:North America-United States-California-IrwindaleOrganization: Biosense Webster Inc. (6010)Job Function: Quality (Eng)Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and 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. EEO is the Law EEO is the Law GINA Supplement