Job Description Summary

Job Description

Job Functions

• Develop and maintain sampling methods and procedures for inspections, testing and evaluation. It supports Quality Operations to guarantee that the products and processes comply with the relevant requirements of the Quality Management System

• Review and approve feasibility studies, process / product changes, technical reports, product transfers, market and clinical trial plans, and protocol reports

• Work with a multifunctional team to support investigations of nonconformities to identify the root cause in a timely manner and recommend provision and corrective actions to avoid recurrence.

• Support activities related to the evaluation of product risks for non-compliant

• distributed products.

• Develop and support supplier audits.

• Maintain documentation related to the provider's quality system requirements.

• Work with product / process transfer projects to ensure compliance with the

• procedures, as well as the facilitation of the activities required in the transfers.

• Work with product / process transfer projects to ensure compliance with the

• procedures, as well as the facilitation of the activities required in the transfers.

• Develop and support ongoing improvement activities to improve 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.

• Other incidental duties

Education and Experience

Bachelor's degree in engineering or Scientific field, 2 years' experience, required or master's degree or equivalent with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education, required.

Required Skills

• Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)

• Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills

• Basic understanding of statistical techniques

• Previous experience working with lab/industrial equipment required (if applicable)

• 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 Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing

• Knowledge of applicable FDA regulations for medical device industry

• Strict attention to detail

• Ability to interact professionally with all organizational levels

• Ability to manage competing priorities in a fast-paced environment

• Must be able to work in a team environment, including the ability to manage vendors and project stakeholders

• Ability to build productive internal/external working relationships

• 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

Work Shift