Title: Senior Quality Engineer
Location: US-New Jersey-Franklin Lakes
Job Number: QUA101K6
Overview:
Accountable for quality support for devices and products developed for and used by BDRx and for achieving key business and corporate goals. The incumbent will achieve these goals through active participation and contribution to multifunctional and multi-divisional teams. The incumbent will be capable of self- direction and project management to ensure successful outcomes.
Responsibilities:
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Provide guidance and Quality oversight to ensure establishment and execution of robust design programs aligned with regulatory requirements and pharmaceutical industry standards
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Support new product development and existing product sustaining activities to ensure work follows proper design control. Ensure controls meet BD and FDA regulatory requirements by actively participating on product development teams and identifying Quality needs, product improvements and customer requirements
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Work with R&D to provide guidance and assure compliance with Design History File procedures and regulations; support retrospective and prospective application of Design Controls for launch products and product currently in development
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Design and support execution of Measurement System Analysis/Gauge R&R/Test Method Validation as needed for new and/or revised test methods
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Provide support and direction for each aspect of design control and ensure tasks are completed adequately to include project planning, design inputs, critical to quality characteristics, risk analysis, new vendor certifications, design reviews, validations, verifications, and design history files and other activities as needed
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Responsible to evaluate design verification results and data utilizing statistical analysis to ensure design delivers an acceptable quality level during manufacturing with properly established product specifications. Ensures the design is appropriately specified and established before transferring into manufacturing to avoid increased risk
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Review and authorize Quality approval for new or changes to existing device design specifications including product performance specifications, test methods, acceptance criteria, and release
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Support shipping studies by providing quality and regulatory requirements, approving protocols, assessing generated data and approving final reports
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Review and assess work performed by R&D and other BD business units such as MS and PS to help ensure Quality issues with device(s) are adequately addressed and when needed corrective actions are taken to prevent recurring quality issues
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Work with BDRx Technical Transfer team (TTT) and Validation team providing Quality Engineering support for Drug/Device transfer, Scale-Up, and Validation, as needed
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Lead or participate in Risk Management activities appropriate to the initiative or situation
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Initiate Corrective and Preventative Action plans and perform efficacy follow up
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Conduct as needed supplier evaluations and meet with suppliers to establish required controls to meet BD and regulatory requirements
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Participate as assigned with supplier and internal audits as a means of evaluating effectiveness of GMPs and established Quality Systems
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Support Regulatory Affairs, as appropriate, by providing input for submissions or response to agency queries
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Support regulatory inspections and/or activities relating to Field Actions as needed
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Supervises personnel, accountable to, and completes additional work and responsibilities as assigned by Director of Quality
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Develop inputs for budget and potentially manage an independent budget within Quality Organization
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Provide training and guidance to personnel to help increase employee knowledge of regulations and standards for Devices and Combination Products
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Support continuous improvement activities to ensure that quality systems and workstreams are optimized for efficiency and compliance
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Works independently with guidance from Director of Quality and/or Manager of Validation and is accountable for defining and helping to execute the quality & regulatory requirements for device design & testing/ validation for BDRx devices and devices in combination with drug products
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Actively partners/liaison with R&D and other functional groups,HQ and multiple site personnel and other internal and external organizations as needed
Qualifications:
* Minimum BS Degree in scientific discipline: Engineering, Chemistry or related science field or equivalent and working competence with class II/III medical devices
* Minimum 5 year industry experience with Certified Quality Engineering (CQE) preferred
* Robust understanding of GMPs as defined in CFR 210/211 & 820 and of industry standards such as but not limited to ICH, ISPE, and ISO
* Excellent people interaction, team building, and communication skills
* Problem solving skills with experience in project management to include organization, prioritization, problem solving, and sound judgment are critical
* Understanding of statistical analysis expected
Job: Quality Engineering