Job Description Summary

Job Description

Develops and maintains methods and sampling procedures for inspections, testing and evaluation. Supports Quality Operations to ensure that products and processes comply with the relevant requirements of the Quality Management System. Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and internal systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

Implement and sustain process improvement projects. Works with quality systems for re-engineering.

Key Responsibilities:
• Develops and maintains methods and sampling procedures for inspections, testing and evaluation. Supports Design related projects to ensure that products and processes comply with the relevant requirements of the Quality Management System.

• Review and approve Design control related documents such as Product Change assessment (PCA), Design Verification, Design Validations and technical summaries for product design changes following the design control system and using statistical tools.
• Performs and present Residual Risk assessment and subsequent activities as part of Post-Market Surveillance.
• Review and approve process improvements and process changes by means of the change control process to ensure product design intent is maintained (Design Control Engineering- DCE) as Quality representative.
• Collaborate and work in the development, implementation and sustaining of the project management program to guarantee projects proper implementation.
• Investigate moderately complex manufacturing product quality and compliance issues (e.g, CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
• Support product/process transfer projects to assure compliance with procedures, as well as facilitation of activities required in the transfer.
• Responsible for assuring validation / qualification of equipment, and process following appropriate procedures and meeting regulatory compliance requirements.
• Develop and support continuous improvement activities to enhance the Quality Systems, using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, SPC, Kaizen lean methods, DOE, etc.
• Analyzes data and interprets standard practices and procedures to establish recommendations for problem solving.
• Responsible for leading multifunctional teams to develop risk assessment activities; creating and maintaining Risk documents including Risk Management Worksheets, Design FMEA and Quality Control Plans for controlling product quality. Supports process improvement plans and strategies that are designed to mitigate the risks identified through Risk Management process.
• Work with a multifunctional team to support investigations related to protocol failures based on engineering principles; analyze results and make recommendations.
• Other incidental duties assigned by Leadership

Education and Experience:

Bachelor's Degree in in Electronic Engineering, Mechanics, Mechatronics, Industrial, Chemistry, Industrial Design or another related field. 2 Years of previous related experience Required.

Master's Degree or equivalent Internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education Preferred.

Additional Skills:
• Good computer skills in usage of MS Office.
• Good documentation, communication and interpersonal relationship skills.
• Basic understanding of statistical techniques.
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering.
• Solid problem-solving, organizational, analytical and critical thinking skills.
• Solid understanding of processes and equipment used in assigned work.
• Knowledge of and adherence to Quality systems.
• Strict attention to detail.
• Ability to interact professionally with all organizational levels.
• Ability to manage competing priorities in a fast-paced environment.
• Ability to build stable working relationships internally.
• Ability to comply with the standards, regulations, procedures and quality manuals applicable.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.

Required Skills

Optional Skills

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Primary Work Location

Additional Locations

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