Job Description:

Job Title:              Quality Assurance Associate 

Department:      Regulatory Affairs & Quality Assurance

Location:             Bangalore

Position’s Objective & Summary:

Quality System management support & coordination, Complaint Handling, Adverse Event reporting & Field Safety Corrective Actions, Regulatory operations, regulatory registrations/filings,

Roles & Responsibilities:

Main activities

• Assist in the maintenance of Quality Management System ISO 13485 and other applicable regulations under direction of Director, Regulatory Affairs Quality Assurance.
• Supports in development and review of company procedures, processes, and documentation to meet the required guidelines for maintaining compliance to the Quality Management System,
• Executes /Implements and supports Quality Management System activities such as Complaint handling, documentation, Non-conformance, CAPA, training, management review, audit
• Coordinates with all process owners to develop procedures as required and implements them.
• Supports training management through ISU, training curricula development, change management, and as required

• Coordinates complaint reporting and adverse event reporting for India Maintain complaint and nonconformance processing through records and tracking systems, including root cause and corrective actions
• Document quality assurance activities with internal reporting and audits

• Coordinate investigations on non-conformances and customer complaint close out and corrective actions
• Supports Audit on-going vendors, systems, and documents to assure quality assurance compliance about all internal procedures as well as regulatory guidelines
• Coordinates execution of Field Safety Corrective Actions in India
• Assist in carrying out internal quality audits on company systems and documentations
• Collaborates with all functional areas of the business to disseminate QMS best practice throughout the organization
• Ensure the timely and effective follow up to all identified or assigned quality issues
• proper maintenance of control documents in Quality Assurance
• Supports the Regulatory Affairs function by ensuring compliance of activities with current internal and external requirements

Additional activities

• Acts independently to determine and coordinate methods and procedures on new assignments and works in teams to install or improve related processes
• Assists and supports other employees, teams, and field personnel as necessary
• Performs other tasks and manages projects as assigned

Required Knowledge, Skills, and Experience:
 

• A Bachelor’s or master’s degree in medical technology, life sciences or similar (or equivalent work experience in similar function)

• 3-5 years of significant experience in Medical Device Industry in similar role
• Ability to handle multiple tasks and to prioritize and schedule work to meet reporting or other deadlines
• Fluent in written and spoken English
• Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook), experience with Agile, CRM and SAP a plus
• Excellent interpersonal skills, ability to work with customers and authorities

Preferred Knowledge, Skills, and Experience:

• Good knowledge and experience of the QMS systems, ISO13485, Indian Regulatory environment and process for medical devices, more specifically
• Knowledge / broad understanding of what it takes to work in a regulated environment, Environment regulations and other related regulations 
• Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices
• Demonstrated organizational and planning skills, including action oriented, focused urgency, and driving for results
• Ability to be effective in complex projects with ambiguity and/or rapid change
• Good team skills with ability to collaborate, influence and lead others
• Orientation for detail work product, with emphasis on accuracy and completeness