AQE Engineer
Becton Dickinson
Summary
BD 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.
Job description
Key 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.
Qualifications
- Bachelor'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 For
- Strong 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.
Requirements
- Bachelor'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
Company overview
Becton, Dickinson and Company (BD) is a leading American multinational medical technology company founded in 1897 and headquartered in Franklin Lakes, New Jersey. As one of the largest global medical technology companies, BD specializes in manufacturing and selling medical devices, instrument systems, and reagents while also providing consulting and analytics services. The company operates through three main segments: BD Medical (focusing on medication delivery and management), BD Life Sciences (specializing in diagnostics and biosciences), and BD Interventional (concentrating on surgical and critical care interventions). With over 72,000 employees worldwide, BD has established a significant presence in virtually every country and serves healthcare providers, hospitals, clinics, pharmaceutical companies, and research institutions. The company is publicly traded on the New York Stock Exchange (NYSE: BDX) and is a component of the S&P 500 index. BD has a long history of innovation, including developing the first insulin injection device in 1924, the first sterile disposable medical device in 1952, and pioneering safety-engineered syringes. The company continues to advance healthcare through its commitment to improving medical discovery, diagnostics, and care delivery while addressing global health challenges.