Be part of something bigger at BD. Here, you’ll join a driven, agile engineering team working in a startup-like environment that has the backing and resources of a Fortune 500 company. In engineering, you could be involved in everything from operations, production and construction to information technology and maintenance environments, all while analyzing and developing solutions to further our engineering capabilities. You’ll use your talent and track record of solving complex problems to achieve one singular goal: advancing the world of health™. At BD, you can make a true difference of one.
Job Description Summary
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
The Quality Engineer I / II title will be determined based on prior exeprience. The general requirements will be the same. The degree of independence and oversight will vary based on the associate being determined to be a QEI or QEII. This position has responsibility for applying/interpreting the applicable Quality Systems, developing/implementing the Standard Operating Procedures and policy's for an organization, such as Quality control, or a manufacturing plant. Develops and maintains schedules and timelines.
Ensures the documentation process remains compliant.
The role provides guidance for the various elements of the Quality System, for example, to ensure process control, consistent supplier qualification practices and identifies/recommends opportunities for continuous improvement (internal/external). Moderate level of application of the appropriate statistical tools to analyze data, identify root cause and corrective actions for effective problem resolution of moderate scope and complexity. May support both internal and external audits by assuming the Lead Auditor role.
Responsibilities include monitoring and trending quality indicators for purchased materials as well as 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 CAPAs and may lead the investigation/corrective action process.
Knowledgeable in specific automated systems as noted and engaged in new product introductions as a possible Core Team member representing the Quality function.
Responsible for the various aspects of Media QM Engineering as well as the day to day QM Engineering responsibilities for assigned product and related operational areas.
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.
Is also responsible for assuring departmental compliance with ISO and FDA requirements through supporting internal and external audits, participation on teams, assigned project support, product launches and process improvements, and coordination and resolution of CAPAs, product quality notifications, change notifications and customer complaints.
This includes using Enterprise tools to ensure compliance and streamline processes.
Facilitates investigation of customer complaints. Implement revision to procedures based on the result of complaint analysis. Initiates preventative action plans and field action plans in response to valid customer complaints.
Develops, documents, administers and maintains Quality Systems for conformance, regulatory requirements and company policies.
Provides advice, updates, and troubleshooting to quality product and processes using technical and enterprise knowledge independently and in team environments.
Uses tools including FMEA, risk analysis, validation, and project management, sampling plans, Six Sigma, control plans and design control.
Supports implementation of corrective actions and improvements by initiating and coordinating SAP data/documentation in current products.
Responsible for initiating and coordinating SAP master data and documentation for product changes and new products.
Drives for continuous improvement in all areas and participates on Continuous Improvement teams and recommends improvements, implements changes and verifies effectiveness of changes.
Performs all duties in accordance with all applicable BDDS Quality, Safety and Operating Procedures.
Supports internal and external audits, and assists in administering the audit program.
Develops and maintains efficient methods for regularly reporting to management the current status of product quality with respect to Quality objectives and goals, and provides plant quality metrics as required to generate quality system improvements.
Defines Change Control requirements for the plant related to manufacturing, facility and material changes. May provide full support to raw material changes assuring that all Quality Systems and requirements are met.
Bachelor's degree. Typical degree in Biological Sciences, Chemistry, and/or Regulatory Affairs. Other fields can be considered with the appropriate experience to support the role.. Advanced degree can make up for experience requirement
2+ years experience in Quality Assurance, Quality Control, or Product/Process non-conformance investigations
PREFERRED AND ADDITIONAL SKILLS/QUALIFICATIONS
Experience in a medical device or pharmaceutical manufacturing facility.
Ability and skill to effectively manage multiple tasks and drive execution of change management plans
SAP transaction experience
Ability and skill to lead or manage process control, supplier quality and continuous improvement projects using statistical technique/tools such as: Statistical sampling, SPC, Minitab
Six sigma, additionally root cause analysis and project management techniques are routinely employed
Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience
Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and formal presentations
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
Moderate knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 9000:2000 and ISO 13485:2003
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 empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
Becton, Dickinson, and Company are an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate based on 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.
Primary Work LocationUSA MD - Sparks - 7 Loveton Circle
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Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
As a new employee what I like most about BD are the many learning and professional developmental opportunities for growth offered. It is good to know that there are so many resources to choose from.
Since joining BD, I really have liked the people I work with on a daily basis and the collaboration towards common goals.
Senior Program Manager
BD is full of passionate, loyal, and driven people that have a common goal of advancing healthcare without sacrificing quality or service.