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.. ]
