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Drive Quality Excellence

3 weeks ago

Thāne, Maharashtra, India beBeeQuality Full time ₹ 40,00,000 - ₹ 50,00,000
Job Title: Quality Compliance Specialist

This role requires an individual to work in the Research and Development (R&D) department. The primary responsibility of this position is to drive quality compliance activities, ensuring that products meet regulatory requirements.

The ideal candidate will have experience in establishing Design Quality Control, Assurance, Regulatory Affairs teams & competence development from scratch within a regulated industry.

Key Responsibilities:
  • Create a Quality culture by driving compliance activities around a specific product, site or region.
  • Experience in Medical Device QMS processes.
  • Organize and drive rigorous compliance of Quality Management System (QMS) processes at a medical device facility.
  • Communicate complex messages and negotiate internally with others to adopt a different point of view.
  • Use high-level judgment to make decisions and handle complex tasks or problems that impact site compliance.
  • Evaluate the quality of information given and ask pertinent questions to stakeholders.
  • Develop comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process-related documentation.
Required Skills:
  • Bachelor's Degree in relevant field.
  • Ability to effectively communicate technical information in English (both written and oral).
  • Experiences in understanding and interpreting Risk Management, Design Controls, Standards & Regulations for Class 2 and Class 3 devices.
Benefits:
  • Masters Degree or Bachelor's Degree in Engineering (specialized in Mechanical / Manufacturing) or Physics, or equivalent experience.
  • Relevant Medical Devices Design work experience in New Product Development.
R&D Expertise:
  • Expertise in India & global Medical Devices Design Controls, Quality Management System, Standards & Regulations.
  • Lead/contribute to Electrical & Electronics technical solutions and products.
  • Design, analyze, integrate, and document products, systems, or subsystems.
  • Provide technical guidance and oversight to include concept development and peer/design review participation.
  • Support verification testing, transition to production, and field issue resolution.
  • Participate in proposals.
  • Mentor engineers/designers.
  • Support, communicate, reinforce, and defend the mission, values, and culture of the organization.
R&D Software Engineering:
  • Executes on the organization's strategy, providing clearly defined success criteria and levels of accountability for individuals in the team.
  • Focusing on customers by understanding their needs to design and implement solutions.
  • Consistently delivers high-quality software at a sustainable speed, maintaining an advanced level of software craftsmanship.
  • Ensures adherence to all applicable development processes, Standards & Regulations, Cyber security, legal, quality, security, and regulatory requirements.
  • Being a Technical, Hands-on Subject Matter Expert in the field of Software Engineering, including Embedded Software Engineering.
  • Contributes to the technical innovation of the product and/or systems which the teams are accountable for by providing insights, hands-on technical reviews, and continuous feedback.
R&D Systems Engineering:
  • Audit support for products for various regulatory agencies (CDSCO/FDA/CE/etc).
  • Customer satisfaction by providing faster engineering resolution to the issues faced by customers.
  • Collaborates with system engineering groups (like INCOSE) and adopt good practices.
  • Develop strategy for knowledge build-up for execute strategy for Life cycle management products.
  • Owning the program deliverables and collaborates with project managers to deliver.
  • Lead teams, fostering collaboration to deliver tasks.
  • Builds productive internal/external working relationships.
  • Strategic thinking from systems perspective to convert from reactive approach to proactive and strategic organization.
  • Innovate on cost reduction, call rate reduction, customer NPS.
  • Innovate on creating new revenue streams together with marketing.