Job Description Summary

Manages Medication Delivery and Vascular Care (MDVC) Quality Assurance activities associated with the product development and product support processes in BD TCI. Ensures that all Design Control quality elements are established and documented to provide a safe and effective product that meets customer needs Lead evolution and improvement of the product development process, policies and procedures which will enable design teams to respond
rapidly to customer needs Runs multiple projects directly while managing other quality engineering resources running separate projects. Provides leadership, quality oversight and direction, scheduling, decision-making, problem-solving and team-building capabilities. Maintains and expands QA/ QS and supervisory knowledge in areas applicable to Quality Engineering.

Job Description

Job Responsibilities

• Manages MDVC Quality Engineering staff and guides the Quality groups in BD TCI in support of product development
• Leads development, sustenance and continual improvement of quality systems in compliance with 21 CFR 820, EUMDR, and ISO 13485 quality systems with a specific focus on the design control requirements
• Runs multiple projects directly while managing other quality engineering resources running separate projects
• Ensures compliance with all local, state, federal regulations, and BD quality policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance principles
• Leads design control compliance within the phase gate product development process as specified for the business. Lead evolution and improvement of the product development process
• Leads or supports cross-functional planning, coordination, and reviews. Initiates and directs QA/QS programs for effective introduction of new products and processes to fulfill the strategic plan.
• Leads Risk Management activities for products under design authority
• Supports quality initiatives for Site issues Work closely with Design Owner and Manufacturing sites globally to resolve customer complaint issues by identifying root causes and developing corrective actions
• Act as a role model/Change ambassador to establish Inspire Quality initiatives through close collaboration with many partners to influence and lead the Quality strategy
• Analyze process and product non-conformances and implement comprehensive corrective and preventive action plans (CAPA)

Knowledge

• Bachelor’s degree in mechanical engineering or related discipline.
• Advanced knowledge of medical device regulations and practices (ISO 13485, 21 CFR 820, ISO 14971, EUMDR etc.), and quality assurance principles and concepts, total quality tools, continual improvement approaches, industry practices, and standards.
• Advanced understanding of design control, disciplined product development processes, regulatory, and quality requirements
• Advanced leadership, motivational, and team building skills, with the ability to lead organizational change.
• Advanced interpersonal skills with the ability to manage, motivate, and influence both up and down the organization
• Understanding of clinical setting and ability to understand customers’ quality and regulatory needs
• Entrepreneurial drive and demonstrated ability to achieve stretch goals in an innovative and fast paced environment.

Skills

• Minimum 5 years of experience in supervising technical/ quality professionals
• Minimum 10 years relevant experience in design quality, quality record documentation, quality system requirements, GMP compliance, quality auditing, and CAPA systems, including or other applicable combination of education and experience
• Extensive knowledge of medical device regulation, industry or international standard, including management responsibility. Ability to interface with regulatory bodies to present technical information
• Successful track record of delivering quality products to market, preferably in the instrumentation and/or medical device industry
• Experience in project planning, management, and leadership
• Experience in a Phase-Gate development process
• Experience of working with multi-disciplinary functional teams; ability to serve in leadership roles on projects or assignments
• Experience of running multiple projects directly while managing other quality assurance resources running separate projects
• Advanced understanding of applied statistics, statistical sampling plans, and statistical process control.
• Experience of leading internal and external compliance audits.
• Practical and demonstrated experience of Quality or Reliability engineering/ QA/ QS, risk analysis, product development, verification/validation testing lead in post launch quality reviews
• Global perspective and ability to integrate people and technologies from many sources.

Desired / Additional Skills & Knowledge (Not essential to the job but will be an advantage to possess)

• Master’s degree in business or related engineering discipline
• Certified Quality Engineer, Certified Quality Manager, Certified Quality Auditor, and/or Six Sigma Green/Black Belt.
• Product design experience in the medical device industry
• Experience in the design and development of quality products in accordance with ISO 13485 guidelines
• Knowledge of engineering performance enhancement tools and continuous improvement in the areas of Design for Six Sigma (such as Voice of the Customer, Statistics, Design of Experiments, and Problem Solving).

Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift