Job Description

General Purpose Summary:

This position supports product leadership and risk management of new product development.

 

Essential Job Functions:

• Leads development of risk assessments and test methods
• Supports component qualifications, design validation / verification and process validation
• Leads basic level 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
• Quality Engineering representation on Product Development Teams.
• Participate and provide input to training on department/division procedures, and policies.
• Participate in project planning, budgeting, scheduling, and tracking.
• Support internal and external supplier audits.
• Develop and implement procedures to comply with corporate and industry standards.
• Provide support to the regulatory department in writing technical submissions.
• Provide positive example and actively promote compliance to division, corporate and industry standards.
• Maintain a professional working relationship with internal and external customer and support staff.
• Prepare and present project updates and technical discussions.
• Support “Voice of the Customer” identification and translation into design inputs.
• Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc. )

 

Basic Skills/Competencies Required:

• Working knowledge in some of the related business technologies.
• Ability to develop solutions with moderate 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.
• Working knowledge of code level review, software logic review, black box testing, and system validation.
• 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
• Software application skills
• 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
• Ability to lead creation of risk management files
• Quality Engineering Certification (ASQ) or equivalent.
• Working knowledge of FDA GMP/GLP, Medical Device Directive, ASTM, AAMI, CEN and ISO
• Injection molding, plastic assembly, and validation experience

Senior Quality Engineer

Education Required:

• B.S. in Engineer or equivalent

Experience Required:

• 3 – 8 years relevant experience in the medical field or closely related industry

 

Physical Demands:

While performing the duties of this job, the employee is regularly required to stand, walk, sit, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to talk and hear.

The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

 

Work Environment:

• Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
• the employee may be in an open cubicle environment. Candidate must be able to work in a team – oriented, fast – paced environment.

Primary Work Location:

IND Bangalore Technology Campus

Additional Locations: Work Shift

 

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