AQE Engineer
Becton Dickinson
AQE Engineer
Job Description
We are the people who give possibilities purposeBD 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 DescriptionBD is seeking an experienced AQE Engineer to support quality, validation, compliance, and continuous improvement initiatives within our medical device manufacturing operations. This role is ideal for an engineer who is hands-on, thrives in a regulated environment, and enjoys leading projects while collaborating with cross-functional teams.Key ResponsibilitiesLead and support equipment and process validations, including development and execution of IQ, OQ, and PQ protocols.Conduct quality investigations, root cause analysis, and corrective actions to address product and process issues. Support supplier quality activities, vendor audits, and regulatory compliance initiatives.Analyze quality trends and drive continuous improvement projects. Partner with Manufacturing, Engineering, Suppliers, and Customer Service to resolve quality concerns and improve processes. Ensure compliance with cGMP, quality standards, and regulatory requirements. QualificationsBachelor's Degree in Engineering. 3-5 years of engineering experience. Strong experience with equipment and process validations, including IQ, OQ, and PQ protocols.Experience leading projects and working within cross-functional teams. Knowledge of cGMP, ISO standards, and regulated manufacturing environments. Strong analytical and problem-solving skills.Excellent verbal and written communication skills. Bilingual in Spanish and English.Experience working with suppliers and supplier quality activities preferred.Experience in a medical device manufacturing environment preferred.What We're Looking ForStrong validation experience.Hands-on approach to quality and process improvement.Strong communication and interpersonal skills.Ability to work independently and drive results.Team-oriented mindset with a commitment to continuous improvement.Comfortable working in a fast-paced manufacturing environment.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 SkillsOptional Skills.Primary Work LocationUSA PR - HumacaoAdditional LocationsWork Shift
Locations
- USA PR - Humacao
Skills Required
- equipmentintermediate
- cGMPintermediate
- medical device manufacturing environment preferredintermediate
Required Qualifications
- Bachelor's Degree in Engineering. (degree in engineering)
- 3-5 years of engineering experience. (experience, 5 years)
- Strong experience with equipment and process validations, including IQ, OQ, and PQ protocols. (experience)
- Experience leading projects and working within cross-functional teams. (experience)
- Knowledge of cGMP, ISO standards, and regulated manufacturing environments. (experience)
- Strong analytical and problem-solving skills. (experience)
- Excellent verbal and written communication skills. (experience)
- Bilingual in Spanish and English. (experience)
- Experience working with suppliers and supplier quality activities preferred. (experience)
- Experience in a medical device manufacturing environment preferred. (experience)
- Bachelor's Degree in Engineering. (degree in engineering)
- 3-5 years of engineering experience. (experience, 5 years)
- Strong experience with equipment and process validations, including IQ, OQ, and PQ protocols. (experience)
- Experience leading projects and working within cross-functional teams. (experience)
- Knowledge of cGMP, ISO standards, and regulated manufacturing environments. (experience)
- Strong analytical and problem-solving skills. (experience)
- Excellent verbal and written communication skills. (experience)
- Bilingual in Spanish and English. (experience)
- Experience working with suppliers and supplier quality activities preferred. (experience)
- Experience in a medical device manufacturing environment preferred. (experience)
- Strong validation experience. (experience)
- Hands-on approach to quality and process improvement. (experience)
- Strong communication and interpersonal skills. (experience)
- Ability to work independently and drive results. (experience)
- Team-oriented mindset with a commitment to continuous improvement. (experience)
- Comfortable working in a fast-paced manufacturing environment. (experience)
- Strong validation experience. (experience)
- Hands-on approach to quality and process improvement. (experience)
- Strong communication and interpersonal skills. (experience)
- Ability to work independently and drive results. (experience)
- Team-oriented mindset with a commitment to continuous improvement. (experience)
- Comfortable working in a fast-paced manufacturing environment. (experience)
Responsibilities
- Lead and support equipment and process validations, including development and execution of IQ, OQ, and PQ protocols.
- Conduct quality investigations, root cause analysis, and corrective actions to address product and process issues.
- Support supplier quality activities, vendor audits, and regulatory compliance initiatives.
- Analyze quality trends and drive continuous improvement projects.
- Partner with Manufacturing, Engineering, Suppliers, and Customer Service to resolve quality concerns and improve processes.
- Ensure compliance with cGMP, quality standards, and regulatory requirements.
- Lead and support equipment and process validations, including development and execution of IQ, OQ, and PQ protocols.
- Conduct quality investigations, root cause analysis, and corrective actions to address product and process issues.
- Support supplier quality activities, vendor audits, and regulatory compliance initiatives.
- Analyze quality trends and drive continuous improvement projects.
- Partner with Manufacturing, Engineering, Suppliers, and Customer Service to resolve quality concerns and improve processes.
- Ensure compliance with cGMP, quality standards, and regulatory requirements.
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