As directed by the Quality Manager, the Senior Quality Engineer is accountable for Quality Assurance in the manufacturing area by developing and maintaining quality control plans, dealing with non-conforming material, customer complaints, remediation projects, CAPAs and providing quality metrics to manufacturing and quality management. This position assures the manufacturing areas are compliant to medical device regulations, good manufacturing practices, and leads continuous improvement activities for improved quality and production.
Job Description
We are the makers of possible
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.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.
Job Responsibilities:
Responsible for the investigation, documentation, root cause, corrective action activities , and disposition of non-conforming material with in a manufacturing unit .
Support a manufacturing unit as an effective team member or leader using continuous improvement and six sigma tools in addressing quality issues and non-conformances .
Analyze and interpret non-conformance and complaint data to identify and vet continuous improvement opportuniti es for quality problems.
Analyze and interpret inspection and process data to identify and vet continuous improvement opportunities for quality problems.
Lead quality improvement projects to reduce recurrence of non-conform ances .
Mentor others in the manufacturing unit to identify and lead quality improvement projects.
Support the implementation of new products, processes, and changes by developing quality plans, approval of validation plans and protocols, inspection methods/plans, work instructions, and raw material specifications.
Responsible for the investigation, documentation, root cause, and corrective action activities of customer complaints.
Develop working knowledge of applicable regulatory, corporate and unit requirements.
Facilitate change control, as needed.
Conduct internal audits as required . Provide audit support for customer and regulatory audits (preparation, closure, etc.).
Communicate across functions and departments for assigned areas of responsibility.
Analyze and verify the consistency of existing products through annual product review.
Perform manufacturing investigations for out-of-specification / out-of-trend investigation for product release .
Writes and leads risk management activities.
May perform other duties as required .
*This is not intended to be an all-inclusive listing of duties . Other job-related duties may be required .
Education and Experience:
This position requires:
Bachelor's degree in engineering or a scientific discipline with a m inimum of 3 years relevant experience or 8 years of a combination of equivalent education and relevant experience.
Preferred qualifications include:
Leadership, project management, and advanced communication skills
Automated high-volume manufacturing experience
Experience with SolidWorks and basic CAD principles
Training in design of experiments and statistics
Knowledge of six sigma methodology
ASQ certified quality engineer (CQE)
Compliance with all local, state, federal, and BD safety regulations, policies, and procedures including RCRA Hazardous waste regulations.
Compliance with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles
Knowledge and Skills:
Effective troubleshooting and r oot c ause a nalysis skills
Good project management skills
Ability to train and mentor others
Strong understanding of the role of quality in an organization
Good d ocumentation p ractices
Technical w riting s kills
Intermediate c omputer skills (especially with Excel)
Effective written and oral communication skills
Physical Demands: (if applicable)
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: (if applicable)
This position is in a clean room or laboratory manufacturing environment and the physical demands described are representative of those that must be met by an incumbent to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions (Per the Americans with Disabilities Act of 1990)
The incumbent may be frequently required to stand and/or occasionally sit for extended periods of time. Bending, stooping and reaching are also frequently required . While performing this job, the employee is regularly exposed to episodes of walking, kneeling, balancing, crouching, pushing/pulling, repetitive grasping, hearing, twisting, lifting, frequent use of hand to finger, handle, feel, pick or type which can include repetitive motion of the wrists, hands or fingers.
The position will almost always have exposure to work near moving mechanical equipment, and potential temperature fluctuations.
Occasionally the position will have exposure to fumes, airborne particles, hazardous chemicals, cleaning compounds and solvents.
The incumbent may be exposed to noise levels in the work environment moderate to loud.
The incumbent must be willing and able to wear required PPE such as, safety glasses, face mask and/or shield, hearing protection, safety shoes, hair and beard net and smock.
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.
