Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Medical Device Lifecycle Quality Engineer

Expired Job

Alku Salt Lake City , UT 84101

Posted 3 months ago

Medical Device Sr. Lifecycle QE


Our client is a large medical device manufacturer. They are in need of a quality engineer to come in and support day to day responsibilities as they grow and integrate.


This consultant will be responsible for helping with our clients day to day quality engineering responsibilities. They will need to be a senior level quality engineer with an advanced statistics background.

They must know how to set up tests/experiments, while ensuring that quality is being held. Alongside statistics, they will need to understand sampling plans and how to create/develop them. They will also be supporting risk management documentation, so they need to have a background in FMEAs.

Since this documentation will be a large part of their assignment, they must understand GDP (good documentation practices). They will be running product failure investigations as well. They will also need a background in non-conformance investigations, as well as CAPA investigation and review. They will also be reviewing and approving protocols and reports from the engineering team. This will include engineering studies, input output matrix, customer level requirements, product level requirements, design changes, and after product launch process changes.


Quality Engineering
Lifecycle Engineering
Statistics and Sampling Plans
Risk Management (FMEA)
CAPA and Non-conformance Investigations
Job Type: Contract

See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Kelly Ocg Software Quality Engineer For Coherex Medical In Salt Lake City F

Kelly Services, Inc.

Posted 4 days ago

VIEW JOBS 12/13/2018 12:00:00 AM 2019-03-13T00:00 <![CDATA[<p>Kelly Services, Inc. is happy to exclusively present an onsite, Full Time, and Direct Hire opportunity for an Software Quality Engineer working with our client Coherex Medical ( a division of Johnson & Johnson) in Salt Lake City, UT! \n \n \n\t * Full Time Direct Hire 1-year Minimum Contract with Benefits and Vacation/PTO!! \n\t * APPLY NOW: start is ASAP beginning of January 2019 \n\t * $40.00-$60.00/hr. based on experience \n\t * Minimum: Bachelor Degree, preferably in engineering: Computer, Mechanical, Electrical, industrial or applicable science. \n\t * 5 to 8 years of work experience, or demonstrated performance. \n\t * While this is a SW Quality Engineer, the qualified candidate is more likely to come from an Engineering background \n \n \n JOB SUMMARY: \n \n The Software Quality Engineer will use tools and quality engineering practices for the effective and efficient development of transfers and maintenance of products / processes in the whole life cycle of the product. \n \n \n\t * The holder of the position will also use the quality engineering principles and investigation skills for the resolution of complex technical problems associated to the manufacturing process at a local or franchise level. \n\t * He/she will use the appropriate risk management to prevent the unforeseen failure modes and improve the capacity of the processes. \n\t * This person will provide support to the business process and supervisor or direct technicians. \n \n \n OVERALL: DUTIES & RESPONSIBILITIES \n \n Business Improvement \n \n \n\t * Revision / analysis of the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and other improvement tools and programs. \n\t * Performs benchmarking to develop more effective test methods to improve quality. \n\t * Establishes the metrics that are the quality indicators. \n\t * Provides support to the development of quality engineering and the compliance of the quality with the adequate abilities for the introduction of new products, and the management of the life cycle of the product. \n\t * Shall be the Subject Matter Expert in the development of Software Validation requirements, strategies, and documentation. \n\t * Revises and approves the engineering change orders. (ECOs). \n\t * Is responsible for updating and maintaining the Software Validation Equipment Inventory and performing periodic review as determined. \n \n \n Compliance / Regulatory \n \n \n\t * Revises / analyzes if the current products and processes (including actions or decisions performed) comply with the regulations, such as the QSRs, ISO 13485, etc, including providing support during internal and external audits. \n\t * Participates in preparation activities for/or interactions with regulatory agencies (FDA, JJRC, BSI, etc.). \n\t * Responds to internal or external audit observations related to the function of quality engineering. \n\t * Properly establishes and maintains the required documentation of quality assurance activities and/or quality systems. \n\t * Performs periodical audits in the line to evaluate GMPs, production controls, lot segregation and audits to the process according to JJPS. \n\t * Revises the audit results of the area to ensure that the corrective and preventive actions are adequate. \n \n \n New Products / Process Introduction \n \n \n\t * Works with NPI and with the manufacturing, process engineering and manufacturing engineering departments to develop, conduct and approve product and process validation strategies. \n\t * Collaborates closely with NPI Engineers to assess and evaluate new equipment development in accordance with the best interest of the Business aligning requirements and regulations as needed. Product Quality, Control and Disposition and Performance Standards \n\t * Attends to Revision meetings of NCs as member of the MRB when necessary. \n\t * Supports the investigations, bounding, documentation, revision and approval of the non-conformities (NCs), preventive and corrective actions (CAPAs), customer complaints and Escalation of quality problems when applicable. \n\t * Analyzes/revises the effectiveness of the preventive and corrective actions when are related to software improvements. \n\t * Approves evaluation and acceptance of components and finished product testing. \n\t * Provides support for the resolution of complex problems (technically) associated to the software validation process at a local or franchise level. \n \n \n Product Grading / Process \n \n \n\t * Revises, approves, IQ, and/or Software Validation, ECO's related to software requirements documents. \n\t * Develops, maintains and checks that the validation methods are appropriate for the manufacturing process. \n\t * Provides support in the revision and maintenance of additional manufacturing documents when are related and/or used as a software requirements document. \n\t * Develops, interprets and properly request process monitoring and control methods consistent with the risk level of the process/product at a software level. \n\t * Evaluates and interprets the common causes vs special variation in the manufacturing process and determines the adequacy of controls for the current processes. \n\t * Evaluates the need of risk mitigation techniques due to the product classification, potential types of defects, defect frequency, severity, patient risk, process capacity, process controls, etc. Determines the effectiveness of these techniques in the improvements previously implemented. \n\t * Responsible to review and approve the risk assessment using FMEA's, MHA's and any other risk document of the process due to avoid, mitigate and reduce risk level related to software. \n \n \n QUALIFICATIONS: \n \n \n\t * Minimum: Bachelor Degree, preferably in engineering: Computer, Mechanical, Electrical, industrial or applicable science. \n\t * 5 to 8 years of work experience, or demonstrated performance. \n \n \n Needed KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES: \n \n \n\t * Use of computer packages. \n\t * Ability to communicate in English, orally and written. \n\t * Knowledge of product / process Risk Management (FDA and ISO regulations), preferably. \n\t * Advanced technical training and experience in the use of Statistics and Lean methodologies and Six Sigma, including Measuring System Analysis, SPC, DOEs, reliability, etc. \n\t * Strong knowledge of statistical software packages, preferably, with the capacity of pre-visualizing, create graphs and analyze data and be capable of presenting data that facilitates the taking of decisions. \n\t * Strong knowledge in equipment development/Integration such as Automation, Top Level Design, Top Level Code Review and/or System debugging. \n\t * Strong knowledge in Regulations that govern Software requirements within the Medical Device Manufacturing Standards. \n\t * Strong knowledge in defining and validating Electronic Records and Electronic Signatures as determined by the competent entity or regulating agency. \n\t * Ability to perform an "active involvement" in the solution of problems and resolution of problems, preferably. \n\t * Capacity to solve problems and provide good judgment, highly desirable. \n\t * Demonstrated management abilities of projects and leadership projects, preferably. \n\t * Certifications such as CQA and CQE (preferably), CBA and Green Belt are a plus. \n \n \n This role is supported by the Kelly Services OCG – Recruiting and Sourcing division. \n \n As your local offices do not support this position, for immediate consideration, please apply online to this posting directly. \n \n If you have questions about the position, you may contact the recruiter at; however, your resume must be received via the \"apply now\" button included within this job. \r\n Why Kelly®? \r\n The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG®) is one focus within the full array of Kelly Services® workforce solutions. \r\n\r\n Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.\r\n\r\n The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs. \r\n \r\n\r\n About \r\n\r\nKelly Services® \r\n\r\n \r\n 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 and connect with us on Facebook, LinkedIn and Twitter. \r\n\r\n Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. ]] Kelly Services, Inc. Salt Lake City UT

Medical Device Lifecycle Quality Engineer

Expired Job