Palm Beach Gardens, FL, 33410, USA
20 hours ago
Senior Customer Quality Product Investigation Engineer & Site Liaison
Johnson & Johnson is currently recruiting for a Senior Customer Quality Product Investigation Engineer & Site Liaison! This position will be located in Palm Beach Gardens, FL. At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity. Position Summary: Manages and maintains the customer complaint systems in accordance with company and regulatory requirements. Conducts complaint investigations, updates and closure. This complaint investigation role exists at the DePuy Synthes Palm Beach Gardens, FL site to perform primary complaint investigation for Velys related complaints. This investigator role includes all elements of complaint investigation with the additional responsibilities of providing product, procedure, and investigation training to the broader DePuy Synthes Customer Quality Investigation Team, coordinating material, design, and photographic analysis conducted by the Research and Development and materials teams, and liaising with the Velys product team. The site-based role is primarily responsible for Joint Reconstruction and Power Tools franchise support but may work across J&J MedTech operating companies where requested and trained to additional Quality Management System requirements. Key Responsibilities: + Investigates customer complaints for product quality issues and concerns. + Physical Investigation of Devices (visual, dimensional, functional) + Review of Medical Records, X-Rays + Photo / Video Analysis + Coordinates complex investigations with key manufacturing, design, supplier and engineering teams to timely / accurate closure. + Approves peer and partner complaint investigations. + Identifies and escalates confirmed manufacturing, supplier, or design caused device failures. + Provides/Coordinates product, procedure, and investigation training for remote Customer Quality teams. + Lead or participate on CAPA teams and act as CAPA and Internal Audit Observation owner. + Represent Customer Quality in Post Market Safety Surveillance (PMSS) reviews and complete action items as assigned from Management Review, trending and PMSS reviews. + Support internal and external audits. + Responsible for communicating business related issues or opportunities to next management level. + Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable. + Follow all Company guidelines related to Health, Safety and Environmental practices. + Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. + Performs other duties assigned as needed. **Qualifications** Education: A minimum of a Bachelors or equivalent University degree is required with a focus in Engineering preferred. Required: + Generally, requires 4-6 Years Work Experience + Experience in the Medical Device industry or medical field + Demonstrated experience in failure analysis/investigation + Ability to Investigate customer complaints for product quality issues and concerns. o Physical Investigation of Devices (visual, dimensional, functional) o Review of Medical Records, X-Rays o Photo / Video Analysis + Ability to work collaboratively with coworkers across multiple functions and geographies + Ability to perform duties in accordance with policies and procedures + Ability to coach/train others (products, procedures, investigation techniques). + Ability to communicate verbally and in writing for documentation of complaint investigations and conduct of training. Preferred: + Knowledge of Joint Reconstruction business and ECM System + Demonstrated knowledge of manufacturing principles and practices + Ability to communicate effectively with diverse business partners + Knowledge of / experience with six sigma and other process excellence tools/methodologies (CQE, PEx Green Belt, etc…) + Training/education methodologies. Other: This position may require up to 10% domestic 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. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
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