Manager – QA & RA – Uttran, Surat

Additional Details

Job Description

QA Manager/ Regulatory Affair Manager from Medical device

Department QA
Designation MR- Management Representative
Qualification M.Sc/M Pham,ISO, QMS
Experience 5-8 Years of Experience
No. of Employees 1
Pay scale Upto 70K



Responsibilities:-

 Maintain operational readiness of QMS and infrastructure to provide testing that is aligned to required standards
 Continuous improvement of the existing QMS including regular maintenance of existing procedures and documentation of new processes and procedures
 Ongoing Quality Assurance activities including Corrective and Preventative Actions, Non-Conforming Processes and Procedures and Complaints handling
 Oversee Risk Assessment process, ensuring compliance with ISO 13485:2016.Oversee Device Risk Management, ensuring compliance with ISO 14971:2019
 Lead continuous improvement as required, reviewing incidents and Root Cause analysis and participating in regular meetings with Quality Managers and Clinical Directors
 Performing Gap Assessment between MDD & MDR and planning Regulatory Strategies for current as well as upcoming products.
 Performing Clinical evaluation of all the products.
 Managing and clearing Technical Audits for CE & other regulations.
 Preparing Technical Files and Device Master Files for product in accordance with MDR.
 Preparing Audit schedules, Conducting Internal Audits, preparing audit reports, Writing Nonconformity reports.
 Train all company personnel in the documented company policies.
 Communicating to the Top Management on Quality issues / Non-conformities & Audit reports Measuring & Monitoring the process performance.
 Representing the management during certification and surveillance audits.
 Ensure personnel have received appropriate training and are assessed as competent to perform tasks.
 Prepare and submit monthly management reports relating to company systems, compliance and incidents.

Relationship Management
 Work as part of the Management team to share ideas and improve operation, recommending, supporting and implementing continuous improvement activities and process and procedure improvements to optimise results and improve quality of delivery, in line with quality standards requirements delivery in line with Company and Customer requirements
 Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance
 Ensure an effective interface with other departmental staff is maintained
 Liaise and communicate with other departments, customers, suppliers and other service providers
 Work collaboratively, negotiate and engage with key stakeholders to facilitate delivery and compliance with the purchasing strategy
 Communicate with stakeholders the impact of market change and potential effects on engineering design and development. Recommend solutions without compromising quality or service while optimising cost
 Stay current and up to date on any changes that may affect the supply and demand of needed products and materials and advise others of any impact
 Contribute to new business initiatives and projects and review and communicate the impact on Manufacturing activities
Skills and Attributes:

 Proven experience as QA in Medical / Pharma industry.
 Conscientious and responsible
 A keen eye for detail and a result driven approach
 Outstanding communication skills
 Excellent organizational and leadership skills
 Excellent ability to train personnel.
 In depth understanding of Management Representative procedures and relevant legal standards