Kelly Services Quality Engineer III in Boulder, Colorado
Sr. Design Quality Engineer in Boulder, CO for 12 months
Regulated industry experience preferably medical 2-4 years of experience in product development driving risk management processes risk hazard analysis, xFMEA, FMA, etc
This position has the responsibility to provide Quality Engineering support to ensure the successful development of Client products and ongoing operational support. This individual will be expected to apply his/her knowledge of design control principles and quality engineering techniques to positively influence development efforts and ongoing manufacturing support as needed. In parallel, this person shall also ensure the products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements. Review and evaluate scientific and technical data as it pertains to product and product testing and lead teams to identify and solve complex product problems. Duties will include identification of gaps in existing design history file and risk management file documentation as related to external requirements standards and reg.s and internal quality system procedures, as well as completion of documentation to efficiently close the gaps.
Actively represent Quality Assurance function on product/process development teams. Provide guidance to Engineering staff and other personnel and ensure that design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, and design review. Lead the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations. Lead or participate in design reviews to evaluate designs and to help identify alternative design solutions. Identify and manage risk throughout the development process with the use of Hazard Analysis, FMEAs and/or other risk management tools. This includes leading the Risk Management efforts of the design process and working with design team and management team on managing product and process risks. Creation, evaluation, and validation of product and process test methods. Evaluates test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives. Provides input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested. Contributes to design input requirements from experience with previously reported problems. Promotes continuous improvement in design control activities and use of quality tools with design team. Participates in supplier selection process and specification reviews with suppliers to ensure that purchased items meet client specifications. Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices. Comply with applicable FDA and international regulatory laws/standards and QA procedures. Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices. Other duties as assigned or required. All activities must be performed in compliance with the Quality System. Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations. All other duties as assigned. Travel requirement: 20-40%
BASIC QUALIFICATIONS:EDUCATION REQUIRED: Bachelors Degree in Engineering or Science Life Sciences, Physics, ME, EE, Industrial Technology, etc. YEARS OF EXPERIENCE 4+ years of exper
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As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
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