Location: South San Francisco, CA
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.. ]
documentation forms are completed properly Properly sorting docs Ability to lift, move and carry medium sized boxes. Follow policies to safeguard data and information Light Filing and scanning Performs other duties and projects as assigned. Skills & Qualifications Great attention to detail Strong organization skills Ability to identify and solve problems Team oriented Light filing and scanning Performs other duties and projects as assigned.
Bilingual Preferable but not required. Company Benefits 401K with company match Medical, dental and vision Optional life insurance Paid holidays Paid vacation and sick days Job Posted by Applicant Pro
established procedures.
Troubleshoots problems to component level. Utilizes general testing equipment, which includes but is not limited to, oscilloscopes, digital multimeters, AC/DC clamp on ammeters, Hi Pot testers, LCR meters, Automated Test Equipment, and custom made test fixtures and test consoles.
In the absence of established procedures, confers with Lead Test Technician, Supervisor Engineering Test - Mfg. or Sustaining Engineer. Properly documents all test findings as required and directed by departmental procedures. Essential Functions: Tests and troubleshoots complex Printed Wiring Assemblies, Subassemblies, Modules and Systems using Functional Test Procedures, Individual
Acceptance Test Procedures, Technical Repair Standard Procedures, Quality Test Instructions, Return Acceptance Test Procedures, and Factory Acceptance Test Procedures.
Performs Factory Acceptance Test of completed systems using Quality Test Instructions and Factory Acceptance Test Procedures. Identifies non-conforming material and initiates Material Discrepancy Reports, FR/FF reports in Tip QA, and Break-Out Shop Orders, as applicable. Programs and verifies programmable integrated circuits using approved procedures and Quality Assurance software. Identifies and initiates changes to test documents using a Quality Test Change Request form. Documents information for failure analysis and
reporting using the Failure Reporting and Corrective Action System and Failure Analysis Reports.
As required, supports Engineering for First Article testing and Qualification testing. As directed by management, tests and troubleshoots test equipment and custom made Test Fixtures and Test Sets using available documentation. Performs other duties as assigned by Management. Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requires a High School Diploma or equivalent and a minimum of 6 years of prior relevant experience or 2 years post-Secondary/Associates Degree with a minimum of 2 years of prior related experience. Must be able to read, understand and accurately follow Engineering Orders, Quality procedures, Test procedures, and operating instructions. Must have a good working knowledge of basic analog and digital components and circuitry. Must be able to correctly analyze and interpret drawings, schematics, wiring diagrams, and specifications. Must be able to correctly document specific details of each test failure encountered, as well as document and update daily status of each assigned repair.
Must be adept at utilization and operation of general electronic test equipment. Preferred Qualifications: Must be able to work well with interdepartmental personnel. Must be self-motivated and have the ability to handle and complete multiple tasks within defined time limitations. Must have a working knowledge of computers. A working knowledge of Microsoft Windows and Office is a plus. In compliance with pay transparency requirements, the salary range for this role is $51,500k - $95,500k.
This is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited to experience and geographic location. L3Harris also offers a variety of benefits, including health and disability insurance, 401(k) match, flexible spending accounts, EAP, education assistance, parental leave, paid time off, and company-paid holidays. The specific programs and options available to an employee may vary depending on date of hire, schedule type, and the applicability of collective bargaining agreements. PDN-9aa97ac2-64ec-4180-8662-f06b3194fb3a
