Lehigh Technical & Professional Service is a leading staffing agency dating back to the 1950's. We specialize in temporary and direct-hire positions in the fields of: IT, Engineering, Manufacturing, Construction, Accounting and Administrative. We are currently partnering with a leading medical device client in their pursuit to hire a Medical Device Quality Systems Manager.
Job Title: Medical Device Quality System Manager
Our client is collaborating with world-class hospitals in the Boston area to turn cutting-edge medical research into usable, meaningful products. We are developing biomedical optical imaging and medical robotics technologies. Drive Quality excellence at our Healthcare Optics Research Laboratory for commercialization of our biomedical devices in collaboration with world-leading medical institutions. We are seeking an experienced Medical Device Quality System Manager (Manager, Quality System (HORL)) professional who will drive continuous improvement of HORL's Quality Management System while managing the document control function and eQMS processes.
Drive continuous improvement of the Quality Management System, including proactive process audits, failure evaluations, root cause identification, and implementation of corrective actions
Manage the Document Control function and other eQMS processes as developed
Collaborate with contract vendors to integrate external processes under the HORL QMS as necessary
Prepare and update Quality documents and SOPs. Review and approve interdepartmental records, documents, and SOPs to ensure conformance with regulations and guidelines
Develop, execute, and document IQ/OQ/PQ software validation protocols for related QMS tools
Implement and maintain a program to report on RoHS, REACH, CalProp65, Conflict Minerals, and other controlled materials
Develop KPI's and regular reporting methods on the same
Regular upkeep, reporting, and maintenance of Quality System data across various tools and databases
Support Management review meetings
Engage with cross-functional teams to facilitate horizontal process improvements
10+ years medical device Quality experience, including demonstrated experience in FDA/ISO eQMS development and management
Demonstrated experience managing document control under a medical device QMS
ASQ certification as CMQ/OE is a plus
B.S. or higher degree in a technical discipline
Experience with MasterControl is a significant plus
Strong working knowledge of FDA, ISO 13485 and MDSAP requirements
Skills: Proficient in Microsoft Office.
Must possess strong oral and written communication skills
This client does not provide visa sponsorship
Nesco Resource and affiliates (Lehigh G.I.T Inc, and Callos Resource, LLC) is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.
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Job ID: 21-02495
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