Associate Director, Supplier Quality Engineering

Job Summary:

Responsible for leading all technical aspects of the Supplier Quality Engineering Team including; supplier performance measurement activities, supplier process validation, supplier training, supplier corrective actions, and supplier continuous improvement efforts to ensure suppliers meet performance requirements in quality throughout the product life-cycle. Develop Supplier Quality Engineering, as well as setting priorities that facilitate effective supplier management. Ensuring Supplier and Material Qualification processes are built into the New Product Development and release process. Working with Supply Chain Management and Business Management groups to ensure new and existing suppliers meet all applicable requirements. They are the primary contact for Supplier Quality Engineering for all Management Reviews, Internal and External Audits. Ensuring that the Supplier Quality Engineering program complies with all applicable regulatory requirements, including: MDSAP (US FDA, EN ISO standards and all applicable international regulations.

Duties & Responsibilities:

• Develop strategies to deploy at supplier facilities focused on continuous improvement of supplied materials and the qualification process to reduce defect levels of products post launch.
• Work with key printed circuit board suppliers to develop their technical product testing capabilities to ensure maximum testing coverage for electrical and functional performance
• Developing, implementing and maintaining a comprehensive Supplier Quality Engineering management system that complies with all regulations and yields improved quality performance of supplied commodities.
• Administer the development of quality engineering requirements for purchased component/assemblies.
• Oversee the reviews with Supplier Quality Engineers to determine manufacturability of components, review and develop risk mitigation controls for supplied parts.
• Direct various technical engineering disciplines to resolve customer return issues related to supplier quality.
• Develop and release documented Advanced Quality Planning Process (APQP) and Production Part Approval Processes (PPAP) and integrate into key supplier workflows. This will help to ensure Supplier and Material Qualification processes are developed and implemented for new product development, sustaining product and all manufacturing and product realization processes.
• Create and implement a proactive supplier development process for suppliers delivering strategic commodities.
• Leads Installation Qualification, Operational Qualification and Performance Qualification activities, test sample size selection, test method validations, Gage R&R studies and risk management activities to assure conformance to product quality standards and applicable regulations.
• Formulate problem solving activities related to design engineering, manufacture, and inspection and test, including CAPA, NCR and supplier related issues.
• Improve current supplier performance evaluation methods in conjunction with Supply Chain and Business Management to address key factors with the potential to impact manufacturing facilities around the world.
• Supplier Quality Engineering performance (Defect levels, improvement in Defect levels from suppliers, reducing the total component failure rate, reducing supplier corrective actions,).
• Compliance with all regulatory requirements (number of, severity of internal/external audit findings, on time performance of supplier audits and related audit closures,).
• New product development (Improvement of device and component defect levels at product launch associated with supplier performance).

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications:

• 10 years' experience in a manufacturing environment with a minimum of 7 years management experience in a regulated industry required.
• 5+ years conducting audits in compliance with ISO and FDA regulations required.
• Comprehensive use and understanding of FDA QSR, ISO 13485, ISO 14971, and other regulatory requirements for medical devices.
• Demonstrated experience improving quality at suppliers through the use of quality tools and practices required.
• Demonstrated ability to work with procurement leaders to improve supplier performance required.
• Problem Solving methodologies ISO 13485, Risk Management ISO 14971, FDA QSR, Design and Manufacturing processes, Supplier Auditing, Supplier Corrective and Preventive Action methodology, FMEA, DOE, Process Capability analysis and Process Validation, Statistics, Value Stream Mapping, Supplier Development.
• Position requires travel a minimum of 20% of the time both domestic and international.

Education:

Bachelor of Science degree, preferably in a technical discipline is required. Master's Degree in applicable Science or Engineering field preferable. ASQ Certified Quality Auditor and/or ASQ Certified Quality Engineer highly desired.

Compensation

The anticipated salary range for this position is $170,000 - $190,000 plus benefits. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience. This position also qualifies for up to 20% annual bonus based on Company, department, and individual performance.

Masimo offers benefits such as Medical, Dental, Vision, Life/AD&D, Disability Insurance, 401(k), Vacation, Sick, Holiday, Paid Maternity Leave, Flexible Spending Accounts, Voluntary Accident, Critical Illness, Hospital, Long-Term Care, Employee Assistance Program, Pet Insurance, on-site Wellness Clinic, Fitness Center and Cafe. All benefits are subject to eligibility requirements.

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Minimum 25% travel is required, along with the ability to travel to Mexico and internationally in order to perform day-to-day supplier assessments and other duties associated with the position. Must also be able to lift 25lbs.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodation may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.