Our client is a industry leading, Billion Dollar Pharmaceutical organization that has grown exponentially in recent years. They are looking for a Quality Management Systems Consultant with experience authoring SOP's, leading audits, and writing statistical SOP's for devices and combo products using statistical techniques, with consistent sample selection. Our client would specifically like focus in the area of closing gaps identified against Title 21 CFR Part 820, ISO 13485 and the 2017/745 Medical Device Directive.
This position requires a broad range of knowledge and experience with the design and development of combination products and the regulatory requirements governing human use products throughout clinical development and commercialization.
Assist in building out the Quality Management System (QMS) based on researching the evolving regulatory landscape against our client's business activities in the US and EU.
Author Policy and Standard Operating Procedures that are based on the requirements defined in ISO-13485 Medical Devices Quality Management System, CFR Title 21 Part 820 Quality System regulation and the 2017/745 Medical Device Regulation.
Perform periodic assessment of regulatory requirements against marketed products and associated controlled documents.
Facilitate revisions to SOPs as required to support the current state of business.
Experience working in a Quality Management Systems, specifically CFR Title 21 Part 820 and ISO 13485.
Proficient with GxP practices in the Pharma and Medical Device Industries.
Experience in working with Electronic Change Control Systems (EDMS).
Experience in technical writing with SOPs, Work Instructions, Technical Reports, FMEA"s.
Proficient with computer systems using the following software; MS Word, MS Excel, MS Outlook, VISIO
Effective communicator using verbal, written and graphical techniques
Effective working in a cross functional group and taking notes in meetings
Min 10 years of experience working in Pharma or Medical Device industries in a quality department role.
BS in engineering or sciences, or equivalent combination of education and experience would be considered.