Senior Engineer, Quality Assurance Engineering at The Judge Group Inc. in Taylorsville, Utah

Job Description:

Location: Taylorsville, UT

Salary: $35.00 USD Hourly - $47.00 USD Hourly

Description: Our client is currently seeking a Senior Engineer, Quality Assurance Engineering for a 12 month + contract.


Education/Special Training Required:
• Bachelor of Science, Engineering or related subject with 2 or more years of experience in a quality or engineering discipline in a manufacturing environment, or


• Master of Science, Engineering or related subject with 0 or more years of experience in a quality discipline Qualifications/Work Experience Required


Who We Want:


A Quality Engineer with the ability to drive quality and deliver results. Someone who is an advocate for quality and lean methodologies; a self-directed professional who can identify issues and communicate effectively to all levels within the organization; a medical device industry professional who is passionate about providing superior quality products to patients and customers.


• Previous experience in a regulated environment desirable (e.g. Medical Device, Aviation, Aerospace, Automative, Defense).


• CQE or equivalent course work / experience desirable


• Proficient in understanding of Med Device manufacturing processes desirable.


• Familiarity with ISO 13485, GDP, GMP desirable.


• Lean Six Sigma training a distinct advantage.


• Excellent collaboration and communication skills and attention to detail. Able to effectively communicate up/down and across different levels of the organization.


• Have a good understanding of engineering and quality practices & methods.


High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.


• Self-starter with demonstrated efficient work methods, analytical & problem-solving skills and ability to handle multiple tasks in a fast paced environment.


• Must be willing to work as part of a multi-site team, with some travel required.


• Working knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.


• Highly developed problem solving and strong analytical skills.


• Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach.


• Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.


• Manages change well and adopts a continuous improvement orientation to the role


• Excellent English (both oral and written)


• Ability to be the voice of Quality when dealing cross functionally


Essential Duties & Responsibilities:


Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:


• Work closely with operations and the business functions to ensure quality performance of product and processes.


• Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.


• Lead and participate in the development and improvement of the manufacturing processes for existing and new products.


• Resolve quality issues with suppliers and partner with internal customers.


• Review and approval of change management activities.


• Maintain KPI for monitoring of process and supplier quality, perform analysis and interpret trends, take action as necessary.


• Ownership and reporting on all quality issues associated with assigned suppliers. Ensure all assigned supplier related material quality issues are effectively communicated to key stakeholders.


• Maintenance of the Approved Supplier List (ASL) in conjunction with the Global Sourcing, Supplier Controls and Audit functions.


• Support execution and analysis of QATs.


• Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.


• Proficient in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.


• Proficiency in and makes continuous strides towards optimization of inspection methods and sampling. Support First Article Inspections.


• Proficiency in statistical methods and application.


• Proficiency in technical understanding of manufacturing prints and tolerancing.


• Support global supplier audit team with key supplier site metrics. Negotiate sustaining quality agreements with suppliers.


• Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.


• Assist in the development, responsible for review & approval of process and equipment validation/qualification.


• Support manufacturing transfers to other plants/facilities, leading quality activities.


• Responsible for initiation, management and support of Ship, Product Holds, potential product escapes. • Coach others in quality topics and activities.


Main Areas of Focus:


• Experience in validations (IQ, OQ, PQ)


• Familiarity with Incoming inspection and part certification

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Contact: eronan@judge.com


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