Johnson & Johnson Careers
Staff Quality Systems Engineer
Requisition ID: 5149180627
Johnson & Johnson Vision is currently recruiting for a Staff Quality Systems Engineer to be located in Santa Ana, CA or Milpitas, CA.
Johnson & Johnson Vision is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, it has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses. In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Primary accountability is to lead the design and implementation of Design Control, Risk Management and Human Factors Engineering Systems to enable the integration of existing Tear Sciences (TS) products and enable incremental changes and new or emerging technologies. This accountability includes -
In this role you will:
- Lead the integration of Tear Sciences Design History, Risk Management and Human Factors Engineering files to ensure that JJSV personnel can interpret TS requirements, specifications, design history adequately while ensuring compliance to regulations.
- Quality Systems Engineering: lead top experts to State the problem, Investigate alternatives, Model the system, Integrate, Launch the system, Assess performance, and Re-evaluate as needed.
- Critical input to quality and compliance planning. Navigate and lead others through Design Controls, Risk Management and Clinical Test Article Manufacturing Procedures as needed while records and procedures are being integrated and/or updated.
- Product and Quality Management Systems standards applicable to Tear Sciences products.
- Critical input to strategic technical planning
- Evaluate process development systems and correlation to product quality.
- Establishing the necessary hazards, hazardous situations and harms to harmonize the TS risk management policies and risk profiles with those of JJSV.
- Ensures recognition, implementation, training and adoption of unique product standards pertaining TS products.
- Define and implement Reliability Systems for TS products.
- Leads quality systems design and adaptation for research and engineering activities for overall and specific new products and/or new technologies.
- Leads quality systems integration and improvements, including VOC, User Needs, Clinical Measures, Design Inputs, Design Outputs, V&V.
- Leads ISO and QSR compliance consulting for NPD, QA and new technologies.
- Serve as technical liaison with contract manufacturing companies solving issues related to optical products and processes. Can related back and forth technical issues and solutions with compliance to existing or in process product standards.
- Performs other related duties as assigned by leadership with limited supervision.
- BS Degree in a technical field is required.
- MS (PhD preferred) in Optics/Physics, Mechanical, Electrical, Optoelectrical or Systems Engineering is preferred.
- Must be technically strong and capable of understanding optical and physical principles, human physiology as well as electromechanical manufacturing systems design and support for equipment change management.
- Minimum of 6 years of relevant work experience is required.
- Experience in Requirements Management, Reliability Engineering and Quality Engineering is required.
- Experience in Product Design, Systems Engineering, QFD (quality function deployment), physics of failure, statistical engineering, quality by design and compliance engineering are preferred.
- Good verbal and written communication skills are required.
- Must feel comfortable working and directing High Level Technical team members such as senior principal and fellows to comply with documentation and compliance requirements without being the SME.
- Capable of building technical credibility quickly with a very broad scientific, medical safety and engineering community.
- Thrive in a world of technical and scientific ambiguity.
- Must be adaptable and feel comfortable moving from one technology to another and adapting to different scientific and engineering backgrounds and ways to interpret laws and regulations.
- Assertiveness articulating requirements and simplifying systems.
- Ideal Certification(s): ASQ- CQE, CRE, CQA; INCOSE CRE, SEP or CSEP; RAPS: RAC
- This position will be located in Santa Ana, CA or Milpitas, CA and may require up to 20% domestic and or international travel.
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.
United States-California-Santa Ana
North America-United States-California-Milpitas
AMO Manufacturing USA, LLC (6240)