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Operations Quality Engineer
Straumann Group
Round Rock, USA
Full-time
Mid
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Summary of Position
Supports and implements systems in the areas of validation, advanced quality, risk management, change control, and design and development. Supports the development and enforcement of internal systems and procedures to meet the local Quality Management System, ISO standards, FDA quality system regulation, and other regulatory requirements. Develops and
implements inspection/validation techniques necessary to verify products meet requirements at the earliest point in the production process. Specifies and implements new inspection equipment and instructs others in its proper use
Essential Functions and Duties
Plans, executes, and reports on equipment and process validation.
Assists with training on quality and compliance concepts and best practices.
Work with Quality team and cross-functional teams to conduct quality investigations, identify root causes, and present potential solutions.
Supports Treatment Planning teams in planning and execution of audits by external partners, regulatory authorities and/or their representatives.
Creates and maintains the Risk Management program and works with internal team on risk mitigation strategies.
Creates and maintains the change management program.
Participates in the development, implementation, and reporting of metrics of interest to local operations, management, and external partners.
Follows safety rules and maintains personal safety and the safety of others, including maintaining a clean and safe work area.
Accurately records and reports of information as required.
Follows employee policy within the company.
Non-essential Functions and Duties:
Attends Quality and other meetings as required
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