Job Description Summary

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.

• Responsible for the investigation, documentation, root cause, corrective action activities, and disposition of non-conforming materialwithin 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 opportunities 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-conformances.

• 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.

• Bachelor's degree in engineering or a scientific discipline with a minimum 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

• Effective troubleshooting and root cause analysis skills

• Good project management skills

• Ability to train and mentor others

• Strong understanding of the role of quality in an organization

• Good documentation practices

• Technical writing skills

• Intermediate computer skills (especially with Excel)

• Effective written and oral communication skills

• 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 frequentlyrequired to stand and/or occasionally sit for extended periods of time. Bending, stooping and reaching are also frequentlyrequired. 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.