Quality Engineer

The Quality Engineer is responsible for overseeing the different advertising projects, activities, and channels that the organization uses to reach customers. Duties include setting goals and a timeline for carrying out an advertising campaign, supervising creatives such as Graphic Designers and Content Writers, collecting data on customer reach and evaluating the success of different marketing methods.

Essential Duties and Responsibilities:

• Utilize key Quality Engineering (QE) principles, tools, and practices to develop and optimize process controls and quality system processes that are aligned with the overall business goals and Nipro Renal Solution’s Quality Policy.
• Partner with manufacturing to implement process improvements and address quality events including non-conformance, product disposition, root cause investigation, CAPA and failure investigation.
• Lead product design changes and risk management activities.
• Collaborate with Quality Laboratory and manufacturing to implement process improvements.
• Lead project and investigation teams.
• Lead customer complaint investigations.
• Lead regulatory compliance projects.
• Partner with manufacturing to lead and/or assist in validation efforts and change controls.
• Collaborate in reviewing and editing quality documents.
• Assist in supplier evaluation and qualification activities.
• Maintain compliance with all company policies and procedures.

Education, Certifications and/or Work Experience Requirements:

• Minimum bachelor’s degree required in Life Sciences or other technical discipline
• Knowledge and expertise in FDA 21 CFR 820, ISO 13485, ISO 14971, cGMP.
• Good writing, communication, and organizational skills necessary.
• CQE or CQT is a plus.
• 5+ years’ experience in medical devices, quality or manufacturing.

Skills/Knowledge Requirements:

• Excellent computer proficiency (MS Office – Word, Excel, and Outlook)
• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
• Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary customer service
• Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard accepted practices.