Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.
Key Responsibilities:
• Investigate manufacturing product quality and compliance issues (e.g, CAPA, non-conformances, audit observations) for all production phases prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
• Optimize or lead Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for manufacturing and for continuous process improvement. Identify opportunities of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
• Develop and update technical content of risk management files and documents (e.g, FMEA, QCP)
• Develop moderately complex training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
• Review and approve technical documentation for manufacturing improvement
• Incidental duties
Education and Experience:
Bachelor's Degree or equivalent in Engineering or Scientific field, 2 years min. of previous industry or industry/education related work experience, required; or
Master's Degree or equivalent, pus internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education, required. Experience in complaints handling and risk management, desirable.
Additional Skills:
• Good computer skills in usage of MS Office Suite
• Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Good understanding and ability to apply statistical techniques to solve routine problems
• Previous experience working in a medical device, pharmaceutical, or highly regulated industry preferred.
• Contributes to the completion of more complex organizational projects and goals
• Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources
• Develops solutions to a variety of problems of moderate scope and complexity
• Identify moderately complex process improvements
• Must be able to work in a team environment, including the ability to manage project stakeholders; may be a key contact representing the organization on projects
• Ability to build productive internal/external working relationships.
• Work is performed independently and reviewed upon completion for soundness in technical judgment, overall adequacy and accuracy
• Participates in determining objectives of assignment; arranges own activities in accomplishing objectives
• Accountable to adhere to applicable Edwards Environmental, Health and Safety and Quality System requirements to ensure our products and services consistently meet customer and regulatory requirements.
• Adhere to all EHS rules and requirements 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
• Ensure proper handling, storage and disposal of all waste generated in the facility according to applicable laws within the waste management program (RCRA). Prepare regulatory and/or internal reports, complete waste determinations, sign waste manifests and coordinate proper training sessions to affected personnel
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
