Location: Redwood City, CA
Company: Johnson And Johnson
modify, apply, and maintain quality standards and protocol for processing materials into partially finished or finished materials product. Develop technical quality plans to strategize and perform product testing. Develop technical protocols to perform studies (Gage R&R, Capability) and Validations (IQ, OQ, PQ).
Track and trend rejects data to investigate trend violations and implement corrective actions. Develop new processes for quality system and rejects management in production. Evaluate and develop PFMEA to identify failure modes to backss the effects and determine actions to be taken to mitigate failures. Lead root cause investigations using Six Sigma problem solving techniques
and tools and implement necessary corrective actions. Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
Evaluate process deviations to ensure product specifications and functionality requirements are met. Conduct quality assurance tests and perform statistical analysis to backss the cost of poor quality and determine the responsibility for products/materials that do not meet required standards and specifications. Develop sampling plans by applying attribute, variable, and sequential sampling methods for test protocols. Coordinate with component and supplier quality team on product issues
and work with suppliers for resolution. Lead CAPA activities to address site wide issues by determining the root cause and implementing corrective action.
Work with cross-functional teams to design new fixtures and to reduce process cycle times. Collaborate with R&D on product specification requirements, verification, and validation strategies. Support engineering team with product / process issues at contract manufacturer's site as required. Master's degree in Industrial / Mechanical Engineering or related field plus 3 years of quality engineering experience in the job offered or related occupation. Position requires experience in the following : 1. Supporting manufacture of medical device under FDA regulated environment utilizing software-controlled systems ; 2.
Experience with creating Inspection methods utilizing contact and non-contact gauging equipment and software controlled equipment ; 3. Statistical sampling methods and process assurance ; 4. p FMEAs, Test Method Validations, Root Cause, CAPAs, Non-Conformance Management, and Process Validations ; 5. Working within medical device regulatory environment (FDA and MDD) in compliance with ISO 13485 and 21 CFR 820 ; and 6. Supporting Design for Reliability and Manufacturability (DRM), Design for Six Sigma, Design for Lean Six Sigma, testing requirements, and risk management per ISO 14971.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long-term incentive, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. For additional general information on company benefits, please go to: - www. careers. /employee-benefits Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual 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.. ]
Quality Assurance (QA) jobs involve ensuring that products, services, or processes meet established standards of quality through systematic activities and measures. These roles typically focus on preventing defects, identifying potential issues, and implementing solutions to maintain quality consistency. Key features of QA positions include rigorous testing, meticulous attention to detail, and a commitment to continuous improvement. QA professionals work across various industries, from software development to manufacturing, to safeguard customer satisfaction and comply with regulatory requirements.
Quality Assurance (QA) jobs involve ensuring that products or services meet certain standards of quality before they reach the consumer. Individuals in QA roles are responsible for planning and implementing inspection processes, conducting tests, and analyzing the results to detect defects. They work to prevent errors and improve the overall quality of the final output. Key characteristics of QA jobs include attention to detail, a systematic approach to problem-solving, and a strong understanding of industry-specific regulations and quality standards. These professionals play a critical role in customer satisfaction and maintaining the reputation of a brand or company.
Quality Assurance (QA) jobs involve ensuring that products and services meet certain standards of quality before they reach the consumer. Those in QA roles are responsible for developing and implementing testing processes, inspecting products for defects and non-compliance, and analyzing quality data to drive improvements. A key characteristic of QA positions is the focus on preventing errors rather than just correcting them, which necessitates a proactive approach and attention to detail. Additionally, QA professionals often collaborate closely with production teams to foster a culture of quality throughout an organization.
Quality Assurance (QA) jobs involve ensuring that products and services meet certain standards of quality before they reach the consumer. Those in QA roles are responsible for developing and implementing testing processes, inspecting products for defects and non-compliance, and analyzing quality data to drive improvements. A key characteristic of QA positions is the focus on preventing errors rather than just correcting them, which necessitates a proactive approach and attention to detail. Additionally, QA professionals often collaborate closely with production teams to foster a culture of quality throughout an organization.
