Onsite- Sr Quality Engineer (Endourology)



 We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.





Job Description

JOB SUMMARY

This position performs various quality engineering functions and owns Quality Assurance/Document Control/Design Control within the scope of their product line. This includes supporting Design Control projects as well as other duties in support of the Quality System, Design Control System, Document Control, Manufacturing, and the R&D/Product Development departments. Additionally, the Senior Quality Engineer functions as a subject-matter resource for interfacing with cross functional partners in Engineering, Operations, and outside suppliers.

ESSENTIAL DUTIES AND RESPONSIBILITIES including the following. Other duties may be assigned.

• •Participates on Project Team as Quality Representative. Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development.
• •Provides Quality Assurance leadership for Project Teams or Quality Department.
• •Builds, reviews and approves Quality System Documents (CAPA, Audits)
• •Crafts, reviews and approves Product Documents, such as Design History Files
• •Creates, reviews, and approves Protocols, Process and Product Validations, Stability Creates, reviews and approves Risk Assessments such as FMEA, FMECA or FTA.
• •Protocols, Software Validation documents
• •Mentors staff
• •Provides supervision to technicians and engineers
• •Analyzes process and product non-conformances and implement comprehensive corrective and preventive action plans.
• •Performs Internal or Supplier Quality System Audits.
• •Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner.
• •Performs Complaint review and investigation as the need arises.
• •Tracks and trends Quality Indicators.
• •Collaborate with manufacturing facility or other Division Facilities.
• •Serves as Independent QA Reviewer and Chairperson for Design Reviews.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements included in this job description are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• •Strong interpersonal skills required in the areas of verbal and written communications.
• •Good listening and assessment skills
• •Good questioning and problem-solving skills
• •Must be a self-starter.
• •Detail oriented and ability to organize large amounts of work and data. This includes the need for good documentation practices.
• •Plans effectively and team oriented.

KEY SKILLS AND EXPERIENCE:

• •Ability to work independently
• •Regulatory knowledge and experience including but not limited to FDA, MDSAP, PMDA, CFDA
• •Demonstrated experience working with international suppliers/manufacturers as it relates to product quality and reliability
• •Demonstrated history of successfully interpreting regulations, and procedures
• •Demonstrated skill in statistical analysis and applied statistical methodologies
• •Knowledge and understanding of IEC 60601 standards

Basic Requirements:

• •BS/MS Engineering (BME or EE or ME)
• •5 years of experience in FDA regulated environment, with 3 years of product design experience
• •2 years of Quality Engineering experience in a regulated environment
• •ASQ Certification preferred

Why Join Us?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

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

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA GA - Covington BMD

Additional Locations

Work Shift