Senior Supplier Quality Engineer

March 12

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Fortive

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Fortive is a global industrial technology company that specializes in delivering advanced healthcare solutions, intelligent operating solutions, and precision technologies. With a team of 18,000 employees, Fortive works on solving tough technical challenges, empowering safer, smarter, and more efficient industrial operations. The company emphasizes sustainability, integrity, and continuous improvement, striving for a future that's stronger, safer, and smarter. Fortive has been recognized as one of America's Most Responsible Companies, demonstrating its commitment to positive social and environmental impact.

Professional Instrumentation • Industrial Technologies • Healthcare Solutions • Precision Technologies • Software-Enabled Workflow Solutions

10,000+ employees

Founded 2016

🏢 Enterprise

⚕️ Healthcare Insurance

💰 Post-IPO Equity on 2020-03

📋 Description

• The Senior Supplier Quality Engineer will maintain quality assurance standards which adhere to Quality System Requirements (21 CFR 820), ISO regulations (ISO 13485) and other applicable regulations to ensure products and services are provided to customer requirements. • Will monitor quality performance of suppliers and external manufacturer’s, implement inspection and test methods for assigned product lines manufactured at suppliers, where required participate in Technical assessments & quality system audits of suppliers to identify potential areas of risks, process variability and address root causes. • Will perform process variability studies, Risk analysis, test method variability and establish sampling plans using valid statistical techniques. • Lead in the investigation of complex manufacturing product quality and compliance issues with assistance from appropriate SMEs (e.g., CAPA, non-conformances, audit observations) for all production processes based on engineering principles; analyze results, make recommendations and develop action plans. • Will provide support to develop and maintain good documentation to support the Validation Process, specifications, manufacturing and test procedures. Support and/or approve the preparation of validation and qualification protocols and support the execution of process / product qualifications & validations (IQ, OQ, PQ) projects with suppliers and external manufacturers. • Will participate and collaborate with Supply chain, R&D Engineering, Operations Engineering and Manufacturing to identify potential areas of process variability, address root causes and implement improvements. Supports in the identification and ensure the optimization of complex Manufacturing processes using engineering methods. • Will participate in preparation of Process/Design Failure Mode and Effects Analysis (PFMEA / DFMEA). • Will participate in new product development team activities in the development and qualification of suppliers. • Responsible for communicating business related issues or opportunities to next management level. • Performs other duties assigned as needed. • Candidate will be required to travel globally for Supplier assessments, Quality Business Reviews and compliance audits.

🎯 Requirements

• 3-5 years of work experience (or equivalent) in the Medical Device industry, medical field or regulated environment, or in other applicable quality roles. • Prior experience within an electro-mechanical or chemical environment as well as previous medical device experience is preferred. • Prior knowledge of medical device regulations such as 21 CFR 820 and ISO 13485 are preferred. • Experience with process validations and the use/application of statistical tools is preferred. • Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts. Candidates who have prior experience in (sampling, design of experiments, process capability analysis) as well as the capability to review manufacturing processes (Control plan, process control and quality control) will be given higher considerations. • This position will have interactions with cross functional teams including but not limited to Supply chain, R&D Engineering, Operations Engineering, Manufacturing, Sourcing, other Quality departments and Regulatory. • This position may have interactions with Government agencies, third party registrars and Customers. • This position will also be interacting with Components and External Suppliers.