Quality Engineer

Job Description

The position will 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.

• 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.
• Attends Quality and other meetings as required.
• Participates in additional training relevant to this position.
• Other duties may be assigned, directed, or requested.

• Bachelors degree in quality, engineering and/or manufacturing fields preferred.

• Must have 3+ years quality control or quality assurance experience in medical device manufacturing field.

• Ability to work with multidisciplinary teams to execute projects, investigations, and training.
• Demonstrated ability to plan and work to robust timelines.
• Experience in planning, execution and reporting of equipment and process validations.
• Excellent understanding of quality principles and good documentation practices
• Familiarity with US and International medical device regulations and registrations.
• Must be familiar with and competent in conducting and managing Risk Management plans and summaries. Familiarity with ISO 13485 preferred.
• Knowledge of design control processes.
• Front and back-room audit experience.
• Must be able to utilize basic quality tools including RCA, Fishbone analysis, SPCs, FMEA, checklists, histograms, Pareto, scatter diagrams, process mapping and flow charts.
• Must be able to produce technical documents, testing and validation plans IQ/OQ/PQ protocols and formal procedures.

• Six Sigma/Lean Manufacturing skills preferred.
• Must have excellent written communication skills.
• Must have basic computer skills (Microsoft Office).

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