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Job DescriptionWe're seeking an experienced Quality/Validation Engineer who wants to work with a highly interactive and dynamic team in our dedicated Microfluidics Innovation Center to provide support across engineering and operational activities to facilitate an environment of compliance and successfully meeting business objectives. Are you looking to serve as a key member responsible for ensuring manufacturing and support activities meet requirements of 21CFR820, ISO 13485, and applicable In Vitro Diagnostic medical device regulations? Do you want to be part of a business venture who manufactures devices that could provide a life changing difference in the medical diagnostic field? If so, join us for these exciting times!Essential Functions of Position - Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Primary responsibility is for Process and Equipment Validation activities
Supporting the inspection process throughout product realization, final product release activities, and ensuring Design History Record requirements are met
Primary responsibility for administering the Nonconformance (NCMR) program
Developing and leading Calibration and Maintenance programs for equipment, as applicable
Supporting responsibility for managing the Risk Management, Corrective and Preventive Action (CAPA), and Supplier Management program(s) meeting external and internal requirements
Supporting the authoring and revision of QMS documentation, preparing information for management reviews, participating in first-, second- and third-party audits as required
Lead improvement projects within the QMS through supportive tools, databases and project plans
Author, maintain, and present quality objectives through data exporting and metrics with professional presentations
Assisting in investigation of product quality and customer product complaints, identification of root cause, and implementation of correction and corrective actions
Assisting in the design and development of methods and tooling for the measurement, testing and inspection of products to support acceptance Qualifications
Bachelor's degree in a related field or equivalent relevant work experience
Minimum 4 years' experience with an established medical device or IVD QMS including extensive experience in the following areas:
Authoring and executing validation protocol and reports
Managing and administering improvement processes in accordance with 21CFR820 and ISO 13485
Administering CAPA database
Statistical analysis for use in various QMS processes
Experience preparing for and participating in internal and external audits
Experience authoring QMS documentation
Advanced proficiency with the Microsoft Office Suite Additional Eligibility Qualifications:
Ideally have worked in a small company/start up environment with successful track record of new products/services introductions in a dynamic market environment
Excellent verbal and written professional communication and presentation skills
Strong technical writing skills
Supplier assessment and approval through site audits a plus
ASQ Certified Quality Engineer and/or Certified Quality Auditor certification desired Equal Opportunity Employer/Veterans/Disabled. To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit http://www.adeccousa.com/candidate-privacy/ . The Company will consider qualified applicants with arrest and conviction records.
Equal Opportunity Employer/Veterans/DisabledTo read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adeccousa.com/candidate-privacyThe Company will consider qualified applicants with arrest and conviction records
