QARA with Medical Devices

6+Months

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.

Best Regards,

Srinath

__________________________________________

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

srinath@deegit.com | www.deegit.com | www.gacsol.com |