BD is seeking a Sr Quality Engineer (Endourology) to join their team onsite in Covington, GA. In this full-time role, you will own Quality Assurance, Document Control, and Design Control, providing leadership for project teams and ensuring compliance with medical device regulations.
Requirements
BS/MS in Engineering (BME, EE, or ME)
5 years of experience in an FDA regulated environment
3 years of product design experience
2 years of Quality Engineering experience in a regulated environment
Knowledge of FDA, MDSAP, PMDA, CFDA regulations and IEC 60601 standards
ASQ Certification (preferred)
Skills & Responsibilities
Design Control: Apply principles of Design Control to new product development and process changes using risk assessments like FMEA and FTA.
CAPA Management: Analyze process and product non-conformances to implement comprehensive corrective and preventive action plans.
Auditing & Compliance: Perform internal and supplier quality system audits while interpreting complex regulations and procedures.
Statistical Analysis: Apply statistical methodologies to track and trend quality indicators and validate processes.
Potential transition routes: People from Quality Assurance Analyst or Biomedical Engineer roles may bring regulatory knowledge and technical design skills, alongside meeting the mandatory engineering degree and FDA-regulated industry experience.
Job description
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.
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.
