Job Description Summary

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. 

Our people make all the difference in our success.

The Quality Engineer II is responsible for applying/interpreting the Quality Systems, technical principles, theories, concepts, techniques, and quality sciences (Microbiology or related) for assigned product and related manufacturing areas.

This position is responsible for supporting related BD quality processes and procedures, including Complaint Handling and responding to Quality Queries from the customers and commercial team. Primary job functions will be to author and/or review complaint investigation summary reports and other post market functions as required.

Job Description

• This role will have primary focus on PMS (Post Market Surveillance) activities- including, but not limited to customer complaints, CID/CAPA, SA/FA, Quality metrics and complaint data analysis.

• Responsibilities include monitoring, investigating and trending customer complaints for manufactured and distributed components/products.

• Assesses Critical to Quality (CTQ) parameters and risk assessment variables as part of the decision-making processes to support predictable product design and flow.

• Initiates and/or supports CAPAs and may lead the investigation/corrective action process.

• Initiates and/or supports Situation Analysis and/or Field action process.

• Initiates and/or supports change notifications (change controls).

• Responsible for the various aspects of Media QM Engineering as well as day-to-day QM Engineering responsibilities for assigned products and related operational area projects.

• Directly responsible to the Plant Quality Manager for the continued consistent implementation/application of Quality Systems as it relates to new and current product lines and Enterprise business systems.

• May support both internal and external audits as a Subject Matter expert (SME).

• Is also responsible for assuring departmental compliance with ISO and FDA requirements participation on teams, assigned project support, product launches and process improvements, product quality notifications, and IVDR compliance. This includes using Enterprise tools to ensure compliance and streamline processes. 

• Other duties as assigned based on business needs.

REQUIREMENTS

• Bachelor's Degree in Biological Sciences, Chemistry, Regulatory Affairs, or a related field with 2+ years of experience in Quality Assurance, Quality Control or Product/Process Non-Conformance Investigations OR Master's Degree with 1+ years of relative experience.

• This is a position that requires onsite support.

PREFERRED AND ADDITIONAL SKILLS AND QUALIFICATIONS

• Experience in a medical device or pharmaceutical manufacturing facility.

• Position requires a sound Quality or technical/Engineering background

• Attention to detail and a commitment to quality.

• Ability and skill to effectively manage multiple tasks and drive execution of change management plans.

• SAP transaction experience.

• Proficiency in technical writing and documentation

• Excellent communication and interpersonal skills with ability to build strong relationships internally and externally.

• Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and formal presentations.

• Strong analytical and problem-solving skills with ability to identify root causes and develop solutions.

• Persistence to drive to solutions despite obstacles and/or competing priorities

• Proficiency in Microsoft Office Suite required, particularly Excel and PowerPoint.

• Basic knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization ISO 13485 and 14971.

• Ability to listen to others; including associates, managers, peers and customers when making decisions and solving problems.

• Ability and skill to analyze data using systematic analytical tools such as Six Sigma, root cause analysis, failure analysis and risk assessment to gather critical information that has moderate to difficult complexity.

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 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.

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At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

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