QARA with Medical Devices
Mounds View, MN
Quality Assurance, Regulatory Assurance (QARA)
· Support R&D, Manufacturing Department to ensure compliance with quality system policies and procedures, FDA and international requirements, and ISO Standards for Medical Devices
DUTIES & RESPONSIBILITIES:
· Experience in setting up Quality Management system and understand ISO 13485/14971/IEC 62304 / QSR requirements.
· Support documentation for CAPA analysis / Closure, Change Management & related QA activities.
· Ability to Perform Gap Assessment of QMS / Includes forms with respect to the following requirements.
· Understanding on FDA requirements – On Mobile health care/ Applications / standards requirements, Cyber Security requirements issued by FDA and MDD Requirements, Guidelines/ standards followed in Network Connected to medical Device.
· Develop Post-Market Surveillance reports
· Experience in acquiring the post market information to generate the Post-Market Surveillance report
· Perform Risk Management activities as per ISO 14971 standard requirements – hands on experience (including, but not limited to, FMEA, Hazard Analysis etc.)
· Research/Data gathering to support ongoing and new product in regards to: Hazards, Complaints review (internal and external (e.g. MAUDE)
· Develop QA plan for Design Function and Manufacturing Activities.
· Develop and initiate sampling procedures and statistical process control methods
· Create periodic quality reports, supporting quality, operations, and engineering functions
· Drive Internal audits, supplier audits, customer audits; properly document activities in accordance with best engineering practices, company procedures, and regulatory requirements. ; Ensuring quality deliverables have been met and comply with regulatory and SOP requirements.
· Ensures compliance with design control procedures and identifies/implements best practices. Documentation support for 510(k) and TF for FDA and MDD requirements.
POSITION & QUALIFICATION REQUIREMENTS:
· Bachelor of engineering with 8 -10 years of experience in Medical Devices Industry ( Lead Role)
· Medical Devices manufacturing Industry experience along with the knowledge of FDA / ISO 13485 , IEC 62304 , ISO 14971 , Cyber security , Network related , HIPAA, Mobility standard requirements
· Certified Internal /Lead Auditor per ISO requirements; Experience with conventional inspection and measurement equipment
· Analytical ability in problem solving; Good communication skills, interpersonal skills, team work. A demonstrated commitment to company values.
Srinath | Recruiter |
Deegit Inc. | GAC Solutions Inc. |
1900 E. Golf Road, Suite#925, | Schaumburg, IL 60173.
Ph: 847-440-2436 * 363 | Fax: 847.330.1987