Job Description Summary

Job Description

As directed by the Quality Manager, the Quality Engineer II is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.

Responsibilities

• Moderate level application of technical principles, theories, concepts, techniques and quality sciences / tools.

• Develops solutions to routine problems of moderate scope.

• Follows company procedures and makes basic procedural updates.

• Developing working knowledge of applicable regulatory, Corporate and/or Unit requirements.

• Communicates across functions / departments for assigned areas of responsibility.

• Is an extended team member representing Quality on new product development projects and a team member for sustaining engineering projects.

• Provides audit support (preparation, closure, etc. activities)

• May perform other duties as required

Design Control   

• Design Input

• Design Output

• Design Verification plans, protocols, and reports

• Design Reviews

• Design Validation

• Design History File support

Change Control

• Assessment of Change Request (ACR) Responses

• Risk Management

• Process Validations

• Identification of CTQ's

• Unit Quality Independent Reviewer During Design Reviews

• Handling of deviations and non-conformances

• Test method validations

• Supplier qualification

• Software validations

• Post Market Surveillance

• Situation Analysis

• CAPA – Root cause investigation and implementation of corrective / preventive actions

• Accurate Use of Statistics (Sampling Plans)

• Advise on Regulations

• Liaise with Manufacturing Plants

• Provide functional support to multi-functional teams

• Internal and external audits

Requirements

Education

• Bachelor’s Degree

Experience

• A minimum of 2 years confirmed experience or a combination of equivalent education and shown experience.   

Knowledge

• Moderate knowledge of applicable regulatory, Corporate and / or Unit requirements.

Skills

• Training in statistics.  Class II / III medical device experience (preferred). 

• Knowledge of design control principles (preferred). 

• Ability to provide support to internal / external audits.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers

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. 

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