Manager - Business Quality & RA

We are currently looking to strengthen our business quality and regulatory affairs team in Bangalore. The role requires extensive experience in BQ & RA for medical devices industry.

Monitoring:

• Collates Product & Process issues from Data / Customer Feedback / Complaints/ production KPIs.
• Provides feedback to management of the Top issues related to Products and Process.
• Monitors the progress/ improvements of the issues and keeps Management updated via QIT.
• Drives QIT meetings to keep the management aligned on day-day QMS topics, issues and fulfilment KPIs.
• Dives annual Management Review to provide annual wholistic view of the Customer feedback & Performance and plan the corrections.

QMS:

• Monitors the QMS system functioning and its effectiveness.
• Monitor completeness and accuracy of the documentation and data relating to various QMS process. Also monitor the QMS related data collection and archiving by various departments
• Coordinate with HODs for any variance in process and restores the process as set by Global Quality

Document Control:

• To Author and Introduce local process (& WIs) for any required customizations to local process.
• To localize/ Modify SOP/WI s to suit to local requirement OR improve efficiency by requesting changes.
• To monitor Implementation of changes relating documents, process, (technical and non-Technical) and its sign off.

RA:

• Supports marketing for Product Homologation.
• Support Marketing for Product registrations with BIS.
• Fulfils all Production and QMS related Audit, Inspections, Reporting from various regulatory bodies.

Training:

• To control the training program in organization
• Allocation of various roles to users.
• Monitoring Training completion progress.
• Monitor Training Effectiveness
• Documentation of training record.
• Maintain Training matrices QMS & Product.
• Update training programs.
• Evaluate need for training of QMS Train various Q Reps (Production, CS etc) to fulfil and follow the processes setup by Global Quality teams.
• As part of Continuous improvement, Train and Involve more and more team members and continuously monitors the accuracy and adaptability of quality Management system.

Retail Support:

Provides RA/ Quality support to chain of customers engaged in Retail of hearing aids.

• 5-8 years of experience in Quality Assurance/Production Quality in Medical Devices/ Equipment Industry is preferred.

• Strong communication skills with all the key stakeholders to ensure QA vision is understood and implemented correctly.
• Flexible with the ability to and work under pressure.
• Proactive, strong-minded, quick thinker and assertive.
• A mature and professional individual who is self-motivated and enthusiastic.
• Exposure to retail business environment towards Providing Technical / Regulatory RA support to the Chain of customers in B2B environment.
• Excellent communicator, influencing skills and negotiation skills to get management buy-in on ideas and concepts.
• Able to communicate with all levels of management and peers within the organization.
• Providing leadership, Building and maintaining relationships.
• Ability to handle conflict effectively. Ability to build, implement and direct quality assurance principles and maintain the quality of delivery.
• Must Have Well versed with MNC / working with international multisite cultures.
• Exposure of Medical Regulations in CDSCO, BIS, Quality standards ISO13485, ISO9001, ISO31000 Exposure of Medical Regulations in US FDA, EU MDR (2017/745), CMDR (SOR/98-282)- (preferable)

At WS Audiology, we provide innovative hearing aids and hearing health services.

Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world.

With us, you will become part of a truly global company where we care for one another, welcome diversity and celebrate our successes.

Sounds wonderfulWe cant wait to hear from you.

WS Audiology is an equal-opportunity employer and committed to creating an inclusive employee experience for all. Regardless of race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, disability, military or veteran status we firmly believe that our work is at its best when everyone feels free to be their most authentic self.