Senior Supplier Quality Engineer

Employer: Auris Health, Inc.
Job Title: Senior Supplier Quality Engineer Job Code : A011.
4061 Job Location : Redwood City, CA Job Type: Full-Time Rate of Pay: $157,700 - $167,700 Job Duties: Collaborate with suppliers and business partners to ensure robust materials, products, processes, and systems.
Support internal and supplier root cause investigations and CAPA.
Lead supplier development projects and drive identified corrective actions and process improvements at supplier to ensure robust process and adequate controls at supplier per Auris requirements.
Manage and escalate supplier issues when intervention or a change at a supplier is vital.
Drive changes and provide guidance to company specifications development to meet DFA/DFM requirements.
Plan, execute, report and follow-up on supplier quality system audits.
Partner with Procurement, R&D, Engineering/Technical Operations, Quality, Operations, and Suppliers in the timely investigation, resolution/prevention of supplier-related issues to minimize/prevent business disruptions.
Monitor and analyze supplier performance metrics using statistical techniques method using Minitab and lean six sigma tools and identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes.
Lead and implement supplier change management process including change notification, dissemination of information, impact assessment, approval of changes, and support material/supplier qualifications.
Own, drive, and lead the assigned Supplier Quality related projects, activities, initiatives with limited supervision.
Utilize Project Management methodologies to plan, organize, connect, shape, lead, and deliver results for SQM projects.
Utilize analytical and problem-solving skills to develop and optimize supplier performance working in conjunction with the Worldwide Supplier Quality Management Team.
Provides Quality System Guidance and training to ensure compliance to applicable standards.
Initiate changes to various QMS documents to keep up to date with latest standard revisions.
Analyze quality data and identify trends impacting risk benefits requirements of product and quality systems for external suppliers, and lead discussions to drive resolution.
Prepare Supplier Quality Agreements and drive discussion with supplier in consultation with cross functional teams.
Develop/execute risk management activities, including the development and implementation of FMEAs, process control plans, and quality agreements at suppliers.
Lead component qualification change projects in collaboration with key business partners and the supplier’s applicable functional groups by performing First Article Inspection (FAI) of the components and process validation activities at supplier.
Develop Part Qualification Plan (PQP) activities and execute the qualification activities in collaboration with supplier as identified in the PQP plan and document a closure report.
Act as the primary engineering contact for incoming, receiving, and manufacturing non-conformances.
Align with all applicable quality management system, environmental, safety and occupational health policies.
Present business-related issues or opportunities to next management level.
Qualifications Master’s degree in Industrial and Systems Engineering, Mechanical Engineering, Civil Engineering, or related technical field and 4 years of experience in the job offered, or in an engineering-related occupation.
Position requires: 1.
Manufacturing practice regulated environment (medical device, or pharmaceutical); 2.
Working in ISO 13485, 21 CFR Part 820, or ISO 9001 compliant environments; 3.
Validation, Non-Conformance, CAPA and SCAR Systems and Production Process Controls; 4.
Part Qualification, Test Method Validations (Gage R&R) and Process Validation; 5.
Minitab and Statistical Techniques; 6.
Process Capability Analysis (Ppk and Cpk); and 7.
Risk Management ISO 14971.
May telecommute.
Position requires 25% domestic and international travel.
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: - https://www.
careers.
jnj.
com/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, sex, sexual 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.
jnj.
com .
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