Quality Assurance Manager - Device Products

Company Name:
Opus Scientific
Quality Assurance Manager - Device Products - Eastern Suffolk County, NY
Opus Scientific has an opportunity for you to use your medical device QA experience in a critical role with great company!
Provide regulatory and device development guidance and assist in the creation, implementation, maintenance and adherence to the Quality Systems required for the development, manufacture and release of medical devices.
Responsible for inspection of incoming device products / components and documentation activities including, but not limited to: Incoming, In-Process, and Final Inspection; Change Control, Deviations/CAPAs, complaints, SOPs, Monographs, Batch Record Issuance, and Storage.
Monitor and Approve in-process device batches to move to the subsequent phase of operation.
Conduct device quality investigations as required including investigations of customer complaints.
Assist in the creation and compilation of all device regulatory submissions.
Development and maintenance of company device SOPs.
Ensure Design Control procedure is followed for each medical devise
Ensuring the design and development of the product is planned and controlled
Maintaining up-to-date design plan, ensuring the plan is reviewed, updated, and approved as the product development evolves
Coordinate interface management
Documenting approved design changes
Maintaining the Design History File
Coordinating design reviews at the appropriate stages and intervals
Scheduling, organizing, and leading the design reviews
Final review and sign-off of investigator regulatory packages for device shipment for device clinical trials
Interaction with FDA and other regulatory bodies as needed.
Manage the Medical Device quality management system ensuring compliance to all applicable medical device regulations.
Manage all medical device documentation, SOPs, Device Master File, Device History Records, Device Specifications, SDS, Inspection records, COAs
Facilitate the Design review process
Assist R&D with Design Plan, Control and transfer activities.
Assist regulatory affairs with product classification, regulatory pathway guidance and product submissions.
Interaction with FDA and other regulatory bodies as needed
Oversight for inspection and release activities of incoming device products / components and documentation activities including, but not limited to: Incoming, In Process, and Final Inspection; Change Control, Deviations/CAPAs, complaints, Monographs, Batch Record Issuance, Storage and release.
Four year degree
5 years experience Quality Assurance in a Medical Device Company
Excellent written and verbal communication skills
Strong computer skills
Flexibility for overnight travel
Commensurate with experience
If you are interested in hearing more about this opportunity, please submit your resume to and include Quality Assurance Manager as the email subject line.

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