3 months ago
This role supports post market quality, continuation engineering, and manufacturing operations, focusing on maintaining the design integrity through product performance monitoring and reporting, post market changes, and supporting/resolving quality issues that arise during production and use. This role will provide quality engineering support and guidance in the transfer of manufacturing sites including: process characterization, process validation, and risk management activities. Review and evaluate scientific and technical data as it pertains to product and product testing problems.
* 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.
* Provide quality engineering input on product activities such as, but not limited to: design changes, process changes, capability studies, test method validation, process characterization, OQ/PQ support, Gauge fixturing designs and implementation.
* Provides input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures
* Familiar with components of the design history file, development phase deliverables and how they are inter-connected.
* Drives a systematic approach in problem solving and process improvement using quality engineering tools such as Six Sigma, DMAIC, Statistical Process Control, Design of Experiment
* Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.
* Applies technical expertise in the quality assurance engineering field and has working knowledge of other related disciplines (Design, Regulatory, and Operations).
* Other duties as assigned or required.
* Extensive knowledge of quality tools: - Risk analysis - Highly proficient in math and use of statistical techniques - Root cause analysis - Problem solving approaches
* Reading and correcting drawings
* Computer literate; use of word processing, spreadsheets
* Project management methods and tools
* Quality System Regulation (QSR)
* Medical Device Directives (MDD)
* ISO procedures / Other Nation & International Standards
* FDA requirements and guidance
* Good Manufacturing Practices (GMP)
* Good Laboratory Practices (GLP)
* Knowledge of sampling methods
* Recognize problems and proactively take corrective measures
MINIMUM QUALIFICATIONS -
Education: Bachelor's Degree or higher in Science or Engineering (or related field)
Experience: 5+ years' experience in Quality Engineering in the medical device industry (or related industry). Familiar with critical elements of the design history file including risk management, design verification and validation tests and ensuring compliance of these elements to procedural requirements. Experience in related engineering areas, e.g. R&D or Manufacturing may also be applicable if experience includes work responsibilities listed above. Advanced degrees may be used reduce required experience.
* Experience in vascular devices, embolic coils, stents, catheters, balloons, aspiration devices, coatings and/or guide wires preferred.
* Demonstrated skills in decision making, preferably across a broad spectrum of Quality Engineering responsibilities
* Quality system gap assessment experience preferred.
* Experience with relocating commercialized product manufacturing, commercialized product remediation, commercialized product acquisition, or contract manufacturing preferred.
* Self-motivated and committed to a team approach
* Strong interpersonal, organizational and project management skills
* Strong oral, presentation and technical writing skills
For more information about this position, please contact the Entegee New Hope, MN office at or .
Please reference job # TF
Equal Opportunity Employer
13 days ago
only 15 days until close
12 days ago
only 16 days until close