Senior Quality Engineer

The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting a Senior Quality Engineer located in Irwindale, CA.
The CSS Group consists of six diverse businesses including Advanced Sterilization Products (ASP), Acclarent, Bio sense Webster, Mentor, SEDASYS¬ and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology, Surgical and Non-Surgical Aesthetics, Sedation and Reprocessing. The CSS Group is committed to delivering innovative products, solutions and programs to address unmet customer and patient needs around the world. Our customers and the patients they treat are our first priority and these values are reflected in Our Credo, which guides our daily decisions and actions. Our relentless commitment to Quality and the principles that define us in Our Credo have helped us achieve significant milestones and continues to help us deliver significant growth year after year.
Participate in new product/process teams to develop quality-engineered systems and products, lead and support design verification tests, process validations, quality processes to 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. Drive quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. May receive technical mentorship on complex problems, but independently figures out and develops approaches and solutions. Shares technical expertise with others and helps develop junior level engineers.
Essential duties and responsibilities
Primary responsibilities include working in Quality Life Cycle management or Quality Engineering and with other functional groups in support of new product/process development.
Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
Leading efforts with quality improvement opportunities as appropriate to legacy products, continuous improvement and customer satisfaction.
Develop and establish effective quality control and associated risk management plans.Write, review and/or approve process and product validation protocols and reports, equipment qualifications, engineering change orders.
Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, Statistical Process Control, Design of Experiment).
Direct Failure Mode and Effects Analysis activities for both Design and Process Failure Mode Analysis's.
Resolve sterility, biological and packaging test requirements utilizing appropriate industry or agency standards for new products.
Ensure that development activities follow design control requirements, product is tested per applicable standards, European Essential Requirements are met per the MDD, and product is properly transferred to manufacturing.
Provide all planning necessary to ensure effective product acceptance. This includes, but is not limited to, part qualifications, specification development, and sampling plans.
Support vendor audits as technical lead as needed and support Supplier Quality as Quality LCM representative as appropriate.
Participate in MRB review of nonconforming product; recommend disposition and corrective action.
Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate.
Assist in complaint analysis as appropriate.
Assist Regulatory Affairs in developing submissions for process changes, inspection changes, and new processes/devices as necessary.
Participate in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
Makes decisions independently on engineering problems and methods, and represents the organization in conferences to resolve important questions and to plan and coordinate work.
Consults with supervisor and provide guidance as needed concerning unusual problems and developments.
You will be responsible for one or more of the following as needed:
Supervise and/or provide guidance to Inspectors and Technicians in Quality LCM activities.
In a supervisory capacity, plans, develops, coordinates, and directs a medium-sized engineering project or a number of small projects with varying levels of complexity.
Work is expected to result in the development of new or improved techniques, refined equipment, materials processes, products, procedures and/ or methods.
Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment when necessary data are insufficient or confirmation by testing is advisable.
Performs other duties assigned as needed.
Bachelor's degree in a related field, along with a minimum of 4 ‚€“ 6 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry is required. Master's degree is preferred.
American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable.
Knowledge of GD&T (Geometric Dimensioning and Tolerancing) is desirable.
Ability to develop and implement Quality standards is required.
Thorough knowledge of Quality and operations systems and processes, including GMP and Quality System Regulation requirements is required.
Strong knowledge of leading edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies is required.
Ability to apply project management skills to ensure fulfillment of new product development requirements is required.
Demonstrated auditing and analytical skills is required.
Ability to train and mentor a diverse array of employees on quality topics.
Estimate travel 5-10%, domestic and international.
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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