Johnson & Johnson Group of Companies is recruiting for Senior Quality Engineer.
Johnson & Johnson’s Cardiovascular & Specialty Solutions (CSS) Group within Medical Devices is recruiting for a Senior Quality Engineer under our Quality System group to be located in Irvine, CA, or Irving, Texas which are key headquarter locations of the CSS companies. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Surgical and Non Surgical Aesthetics, Sedation and Reprocessing.
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The Quality Engineer will have responsibilities for operating companies under Medical Device Sector (Acclarent, BWI, Cerenovus, Depuy, Ethicon, Mentor, Sterilmed) with a variety of products, from implantable devices, respiratory products, surgical instruments and device reprocessing.
The Senior Quality Engineer should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. You should be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and MarketingSummary of the job
Reporting to Sr. Manager, Escalation/Field Action, this individual is responsible for development, implementation and support of product escalation and Product Risk Escalation (PRE) Board/Risk Management Board (RMB) processes for any of CSS CompaniesEssential duties and responsibilities:
To work under limited supervision to make compliance decisions to meet departmental and internal/external customer needs. You will own the Risk Management Board and Quality Review Board (QRB) activities by: leading meetings, ensuring process is executed per procedures, coach investigators in proper problem definition and risk assessment, write meeting minutes, route and verify document review duties. You will be responsible for reporting on quality system performance metrics to appropriate review boards such as Management Review, CAPA Review Board, Q&C Dashboard, etc.
To serve as liaison member between the QRB and Field Action Management Team, to ensure proper transition of QRB actions and documentation that the Field Corrective Action Lead will use to report to regulatory authorities.
To facilitate root cause investigation, documentation, trend analysis, corrective action recommendations, and project management on RMBs; initiate and or approve document change orders as applicable for job; provide periodic reports, completes special assignments, assists manager as requested; and lead and participate in cross-franchise teams as directed by manager.
To evaluate events and trends within the quality system, to assure safety, efficacy, and quality of products throughout their lifecycle through Product Quality & Health Risk Evaluations. Presenting Product Quality, Health Risk Evaluations and Quality Review Board investigations weekly to executive management. Documenting these assessments in a timely and compliant manner.
Directly support and presenter of the product quality issue process during internal and external audits/ inspections.
Additional responsibilities (not limited to): lead and participate in special projects as assigned; act as backup support for Field Corrective Action Lead; and act as backup for other Product Issue Quality Engineers.Qualifications
Bachelor's degree in a life science, engineering, physical science or related discipline.
Minimum of 3 years in medical device manufacturing or related industry experience.
At least 4 years of experience as a Quality Engineer in an FDA-regulated industry
Advanced skills on Microsoft Office, project management and Statistical Techniques knowledge.
Prior Experience in ISO 13485 and 21CFR 820 FDA regulated Environment.PREFERRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:
An Advanced degree in a related field is an asset. You should have the ability to work independently and partner with a multi-functional team. Quality Engineering/ Design or Process Excellence/ Lean Experience. ASQ or Six Sigma Certification. Mechanical products knowledge. Excellent social relations, negotiation, decision-making and interpersonal skills cultivating a conflict resolution to technical situations are desired. Risk Management and Root Cause Analysis
This position preferred locations: Irvine, CA or Irving, Texas and requires up to 10% domestic U.S. or international travel. Additional locations to be considered: Miami, FL; Raynham, MA; Cincinnati, OH; Warsaw, IN; Leiden, Netherlands; Somerville, NJ
No direct staff responsibilityLeadership Imperatives