Johnson & Johnson Careers
POST MARKET SURVEILLANCE QUALITY ENGINEER II
Descripción del Trabajo
Requisition ID: 1905735686W
“Johnson & Johnson companies are equal opportunity employers”
The Global Job Posting policy promotes the commitment to the advancement and development of our employees. We invite you to read this posting and apply if you are interested in the position and meet the requirements.
Biosense Webster, Inc. is recognized worldwide as a leader in the science behind the diagnosis and treatment of cardiac arrhythmias. We help patients around the world regain their health, their energy and their lives. Guided by the needs of electrophysiologists and cardiologists, Biosense Webster, Inc. has pioneered innovative technological advancements for more than 30 years. Join us as we continue to look for new and better ways to help physicians heal more hearts. Because that is what we do -- we put lives back in rhythm.
Searching the best talent for: POST MARKET SURVEILLANCE QUALITY ENGINEER II
Responsible for the execution of the business improvement initiatives in the plant. He/she conducts, analyzes, designs and improves the business process by identifying and influencing multifunctional teams, that are able to provide tangible results to the business through the application of methodologies or tools such as Six Sigma and lean manufacturing principles. Using his business abilities, leadership and technical knowledge, the Excellence Process Manager executes and monitors projects in the plant.
If CSS Position: This position will have responsibilities across ETHICON and Cardiovascular and Specialty Solution (CSS) Companies Johnson and Johnson Family of Companies) including a span of multiple product platforms such as General Surgical Devices, Sutures, ENT, Infection Prevention, Electrophysiology and Surgical and Non-Surgical Aesthetics.
DUTIES & RESPONSIBILITIES
Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
• Is responsible for the improvement projects related to quality, supply chain and costs reduction.
• Will direct process improvement initiative that include resources administration, deadlines and change administration tools.
• Collaborates and work in a team with different functions of the company.
• Is responsible for the display of improvement tools such as Six Sigma and Lean Manufacturing through follow up and training of all the levels within the plant.
• Creates sustainable improvements through the application of DMAIC, Lean and ME2.
• Assists in PE training administrations, certifications, recertification and savings if necessary.
• Follows up and observes all the regulatory requirements (GMPs, ISO, FDA, internal policies) applicable to the area of responsibility.
• Is in compliance with all the J&J safety requirements, safe work conditions and applies them within his/her department.
• Responsible for the development and implementation of process improvements using Lean Manufacturing, Six Sigma and Excellence tools in the Manufacturing Teams within the plant.
• Supervision Responsibilities:
• Manages multiple Engineers and Technicians who are his/her subordinates.
• Responsible for the complete direction and evaluation of his/her Unit.
• Directs his/her subordinates according to the applicable policies and laws.
• His/her responsibilities include interviewing, hiring and training of employees, planning, assigning and directing their work, monitoring their development, as well as acknowledge and discipline employees, assign complaints and solve conflicts.
• Responsible for communicating business related issues or opportunities to next management level
• 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 needed.
• Evaluates Safety Signals through data analytics mainly, Adverse Event reporting, Non-Conformance Reports, Corrective Actions/Preventative Actions, Customer Feedback and FG Product testing data utilizing the following tools/techniques:
o Facilitate cross-functional team meetings as well as lead and influence a variety of individuals and/or groups.
o Executes the PMS process with a primary focus on product performance, safety and efficacy.
o Active member of PMS data reviews for both reactive and dedicated data sources.
o Collaborates with internal partners, mainly, R&D, Operations, Medical Affairs and Marketing.
o Develops and maintains PMS tracking and trending reports as assigned by manager. Supports Managers or Director on various projects.
• The post market surveillance data set is large and includes reported product complaints, malfunctions, and adverse events, as well as capital equipment service records, clinical reviews, company-sponsored funded registries, post-market studies, and literature reviews. As required, responsible for summarizing trends, signals, and escalations.
• Responsible for creating and delivering the post market surveillance plans and the post market surveillance reports for the company’s products to be used as an input into technical, safety and regulatory documentation.
• Ensures appropriate governance of complaint coding schemes. Links post-market quality systems to risk management files as appropriate.
• Executes filing of appropriate post-market, safety surveillance-related submissions and reports to regulatory agencies worldwide in accordance with Quality System procedures. Supports engineering and other ad-hoc data queries in support of CAPA and other post market quality related requests.
o Completes projects/other duties as assigned. Provides support during external and internal audits of the customer quality process. o Responsible for communicating business related issues or opportunities to next management level
o For those who supervise or manage a staff, responsible for ensuring that 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, if applicable
o Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
o Performs other duties assigned as needed.
REPORTS TO: MANAGER OF POST MARKET SURVEILLANCE
EXPERIENCE AND EDICATION:
· A minimum of a Bachelor of Science degree is required. in a technical, scientific or engineering field or a related technical field is required.
· A minimum of 2 years of relevant experience is required. An Advanced degree is preferred. Ability to work efficiently with general supervision is required. Strong quantitative and critical thinking skills are required.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:
· Strong technical writing skills are required. An understanding of basic statistical analysis is required. Experience with statistical tools such as Six Sigma, Statistical Process Control, six sigma green belt or black belt certification or equivalent statistical experience etc. is preferred. Experience with technical documents is preferred.
· Demonstrated ability to identify issues in post-market surveillance, complaints and service is preferred. A demonstrated analytical capability with the ability to summarize data into graphs, charts and statistics is required. Experience with analysis and signal detection in a large data set is preferred. Understanding of Risk Management (Medical Device) is preferred.
· Experience working in a regulated environment or quality functional area with a demonstrated competency in quality system regulations specifically to the FDA is preferred. Past experience executing data management tasks is preferred.
· Ability to write and communicate in a professional manner, including generating and presenting well-written reports and presentations is required. Demonstrated ability to work effectively with cross-functional teams required. Past experience working with complaint investigations, root cause analysis, identification and implementation of CAPAs are preferred. Ability to effectively prioritize and handle multiple activities and responsibilities is required. Project management skills and the ability to maintain excellent electronic records is required. Experience with basic office software tools (e.g. Microsoft Word, PowerPoint, Excel) and internet browsers (e.g. Internet Explorer, Chrome) are required. Experience with electronic Complaint Management System is preferred.
Global Leadership Profile Competencies:
Collaboration and Teaming ~ puts interests of enterprise above own; works well across functions and groups; builds teams effectively; inspires follower ship; instills a global mindset
Results and Performance Driven ~ assumes personal ownership and accountability for business results and solutions; willing to make tough calls; consistently delivers results that meet or exceed expectations; demonstrates a track record of people development; champions diversity; net exporter of successful talent
Prudent Risk-taking ~ inner confidence to take risks and learn from experience; courage to grab opportunities or shed non-viable businesses
Sense of Urgency ~ proactively senses and responds to problems and opportunities; works to reduce “cycle” time; takes action when needed.
México-Chihuahua-Ciudad Juárez-Circuito Interior Norte 1820 Parque Industrial
Cordis de Mexico S.A. de C.V. (8286)