Job Information
BD (Becton, Dickinson and Company) Lead Quality Engineer in Bengaluru, India
Job Description Summary
This position supports product leadership and risk management of new product development and sustaining activities.
Job Description
Essential / Key Job Responsibilities (including supervisory and/or fiscal):
Technical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance)
Leads development of risk assessments and test methods
Leads component qualifications, design validation / verification and process validation
Leads product investigations
Ability to make and present risked based decisions
Assess product changes against product design
Supports translation of design inputs into manufacturing control plans
Develop and implement procedures to comply with corporate and industry standards.
Coordinates and/or directs all aspects of product development activity related to a product line
Leads development of risk assessments and test methods
Quality engineering representation on Product Development Teams
Prepare and present project updates and technical discussions
Participate in project planning, budgeting, scheduling, and tracking
Support internal and external supplier audits
Provide support to the regulatory department in writing technical submissions
Complies with company procedures and policies, government regulations
Other duties and projects, as assigned
Required Qualifications:
Knows how products are used and impact the user(s) so that risk can be managed effectively
Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)
Ability to lead creation of risk management files
Ability to develop solutions with business impact
Advanced statistical and risk assessment techniques
Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies
Ability to make and present risk-based decisions
Strong interpersonal skills
Ability to analyze and optimize manufacturing and quality systems
Product, design & prototyping
Ability to create and provide training
Problem solving ability
Ability to create, review and coordinate test protocols and reports
Ability to generate engineering proposals
Oral and written presentation skills
Ability to Lead cross functional teams
Understanding of regulatory requirements including ISO 13485, ISO 14971
Preferred Qualifications:
- Quality Engineering Certification (ASQ) or equivalent
Education and/or Experience:
BS in Engineering
Minimum of five years’ experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry
Physical Demands:
While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
Work Environment:
While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
Primary Work Location
IND Bangalore - Technology Campus
Additional Locations
Work Shift
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
BD (Becton, Dickinson and Company)
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