Senior Quality Engineer I - Validations, Risk Management & Statistics (Plainsboro)

Sr. Quality Engineer / Quality Operations

Changing lives. Building careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Sr. Quality Engineer / Quality Operations (Validations, Risk Management & Statistics) will provide Plant Quality compliance support for the following Quality tasks and duties : Assist in the Introduction and launching of new or improved products and processes into the Manufacturing Site. Participate in problem solving teams. Facilitate from a Quality Engineering & Quality Systems and Plant perspective the launching of new or improved products / processes. Provide guidance on the development and implementation of new and updated Quality System procedures for ISO / QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs, development and task force projects. Facilitates the development, implementation and monitoring of quality programs and policies that ensure that the development, manufacture and distribution of medical products is in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 9001, ISO 13485, the Medical Device Directive, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies.

Primary responsibilities are :

(Validations, Risk Management and Statistical Process Controls)

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Assists in the launching of new or improved products / processes, and the transfer of technology from development to commercialization from a Quality and manufacturing perspective.
• Providing guidance on the development and implementation of new and updated Quality System procedures for ISO / QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs, development and task force projects.
• Participate in the execution of Process FMEA and other applicable risk analysis documentation as deemed appropriate.
• Develop statistically based sampling plans for in-process and finished goods testing, inspections, validations and where required. Provide Statistical Analysis of the data to support all Quality Systems documentation such as validations, NCs, Complaints, etc.
• Develop, review and approve validations and completion reports for new and existing products, processes and equipment.
• Prepare monthly and quarterly trending, including Statistical Process Control documentation, and support the Quality Management Review Process.
• Maintains a thorough understanding of the following regulations and guidelines : U.S. Food and Drug Administration (FDA) regulations, ISO 9001, ISO 13485 : 2003, Medical Device Directive (MOD), the Canadian Medical Device Regulations (CMDR), Integra Corporation's policies and procedures, and other applicable regulatory agency requirements.
• Participate in FDA inspections, ISO Certification and surveillance audits and customer audits.
• Perform other Quality Assurance and Quality Engineering related duties as required.

The requirements listed below are representative of the knowledge, skill and / or ability required for this position.

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