ASTRIX CAREERS

QMS Senior Consultant / Specialist

Astrix Technology is a full-service recruiting staffing firm for temporary, temp-perm and direct hire positions within the Technological realm. Our expertise falls within the Scientific, IT and Engineering marketplace staffing entry level positions up to executive level.  We support many of the world’s top Fortune 500 scientific companies and growing companies across all industries. We are a company of Scientists, IT professionals and Recruiters who focus on our client’s business which is our business – Scientific, Technology Staffing and Solutions. To Apply for this position – please email your resume to Sarah Houghton – shoughton@astrixinc.com

Position Summary

We are looking for a Quality Management Systems Consultant to join our team who will be responsible for creating and maintaining our client’s QMS in compliance with the US FDA regulatory requirements for software, ISO standards and related software regulatory requirements in other countries.  The Consultant will also support our client’s deployments of our software in regulated research, development and manufacturing environments, as well as client’s internal policies and procedures.  The Manager will be responsible for software quality documentation, tracking, follow-up activities, and metrics, working collaboratively with software development, commercial operations, legal, and other cross functional areas.

Primary Responsibilities

• Helping clients with Quality QMS strategy, roadmap, assessments and implementations.
• Ensuring that the client’s Quality Management System is created in compliance with the appropriate Policies, standards and regulations.
• Taking a lead role in the client’s Quality Management Planning activities to ensure continued compliance, visibility, and appropriate planning for changes impacting the QMS.
• Leading QMS activities including Audit Management, Management Review, Change Control, Document Control, and Training integration.
• Defining and maintaining the Quality Management System structure to ensure compliance to Policies, including but not limited to, ISO 13485, 21 CFR regulations, and EU Medical Device Regulations.

Qualifications

• Excellent organizational and time management skills
• Excellent communication, negotiation, presentation skills; and good listener
• High level of analytical/problem solving skills
• Bachelor’s or Master’s degree in a scientific or technical field
• 4+ years of experience in the pharma, medical device or similar industry
• Strong understanding of the regulations and requirements governing the establishment and maintenance of a Quality Management System
• Strong experience in validating IT GxP systems.
• Experience driving project teams to deliver business application implementation projects as well as experience as an active contributor on projects with scheduled deliverables.
• Solid Analytical skills – demonstrated ability to trouble-shoot complex process/system issues.
• Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other char