imds: Innovative Medical Device Solutions
Quality Engineer Vandalia, Ohio
Apply online at imds.applicantpro.com
IMDS, a leading innovator in contract, full-service medical device development and manufacturing, is searching for a Quality Engineer for our Vandalia Ohio facility.
The Quality Engineer Plans, executes and collaborates on appropriate quality engineering practices to ensure continuous production of products consistent with established standards, competitive benchmarks, and highest customer satisfaction.
Key Roles and Responsibilities:
Well versed in the various components of a strong quality system and how these components interact to provide confidence in production results.
Able to audit a quality system internally or externally.
Fundamental understanding of regulatory requirements, documentation and traceability control, testing and measurement principles, and containment.
Fundamentally sound understanding of inspection techniques, physical testing and measurement principles.
Establishes or improves inspection methods based on sound command of engineering first principles.
Familiarity with basic principles of machining and production environment.
Working knowledge of company's ERP as well as other business and Quality IT tools.
Validation duties may be required as applicable
Excellent attention to detail.
Excellent analytical and problem solving skills
Familiarity with ISO quality systems.
Proficiency in analyzing and correcting complex process issues using independent thinking and decision making.
Ability to plan, organize and implement multiple concurrent tasks
Ability to effectively participate on multi-disciplinary teams.
Recognized as a technical leader within the company and engenders trust when working with customers or suppliers.
Capable of leading a Continuous Improvement Team, CAPA team, or working with a customer or supplier to resolve a quality issue.
Works effectively on cross functional teams to establish appropriate preproduction processes pertaining to quality.
Proficient in of all aspects of running an effective team, including but not limited to project planning, effective team meetings, effective documentation and training
Known for driving swift, effective action and getting results that persist.
Acts with ethics and integrity in all environments safeguarding the quality needs of both the end user and the customer at all times.
Excellent written (including email) and oral communication skills
Ability to communicate effectively at all levels within the company.
Ability to formulate responses to common inquiries or complaints from customers and regulatory agencies.
Capable of presenting data, methods, findings, and remediation effectively across broad audiences.
Bachelor's degree in Mechanical, Manufacturing or other related Engineering disciplines from four-year College or University or 6 years of quality experience is required.
ASQ Certification highly desirable.
Previous work experience in a Quality Medical Device Manufacturing environment preferred.
Experience working with Quality Systems is preferred
Visual acuity of 20/40 or better (with corrective lenses if necessary) is required.
Basic ability to read, establish and interpret quality specifications, including GDT nomenclature, material composition, proper handling and disposition.
Strong working knowledge of Microsoft Office applications, including Word, Excel, PowerPoint and Project.