New · posted Nov 11
Becton Dickinson · Medical Devices
Sr Quality Engineer (Endourology)
- Covington, GA
- On-site
- Full-time
- Senior & Principal
The role
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.
What you need
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
Required Skills
Optional Skills
- 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.
- 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
Pay
Becton Dickinson didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
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.
Where you'll work
Covington, GAOn-siteOpen in Maps (opens in a new tab)
More jobs in Covington, GAWorking conditions
Primary Work Location
USA GA - Covington BMD
From the posting
About BD
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.
Equal opportunity, accessibility and legal noticesBecton Dickinson's statements, word for word
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.
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.
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in the US49 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $114,500 | $128,000 | $135,000 |
Comparisons: the base pay employers published on open Design Quality & Assurance roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Design Quality & Assurance
The general path across 75 open Design Quality & Assurance roles on Regulatory Jobs, with the titles they carry most. Not BD's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 34 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership7
- Documentation and SOPs6
- Quality systems and risk5
- GMP and compliance3
- Investigations and CAPA3
- Lab testing and methods2
- Validation and qualification2
- Clinical trial conduct2
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Design Quality & Assurance work in medical devices, led by the three this posting names, each linked to the agency or standards body that publishes it.
- IECIEC 60601-1(official source, opens in a new tab)Basic safety and essential performance of medical electrical equipmentNamed in the posting
- FDAMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program shared by five regulatorsNamed in the posting
- PMDAJapan PMDA(official source, opens in a new tab)Japan's Pharmaceuticals and Medical Devices AgencyNamed in the posting
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- IECIEC 62366-1(official source, opens in a new tab)Application of usability engineering to medical devices
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA human factors guidance(official source, opens in a new tab)Applying human factors and usability engineering to medical devices
- IECIEC 62304(official source, opens in a new tab)Software life cycle processes for medical device software
- ISOISO 10993-1(official source, opens in a new tab)Biological evaluation of medical devices within a risk management process
- FDAFDA cybersecurity in medical devices(official source, opens in a new tab)Quality system considerations and premarket content for device cybersecurity
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification: showing substantial equivalence to a legally marketed device
Company hiring pulse
BD on Regulatory Jobs
- 104
- Open roles
- 104
- Distinct roles
- 23
- Locations
By discipline
- Quality78 74%
- Regulatory19 18%
- Clinical8 8%
By level
- Senior & Principal49 47%
- Associate & Specialist35 33%
- Manager17 16%
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Sr Quality Engineer (Endourology) at BD
Open until filled.