Manager, Quality Engineering

Job Description Summary

Manages all 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

6. Job Responsibilities

• . Manages 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)

7. Knowledge and Skills

a. Knowledge

b. Skills

Required Skills

Optional Skills

Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift

Skills Required

Iso 13485, design control, Iso 14971, Quality Auditing