BD
Job Description Summary
The Quality Engineer II/Sr title will be determined based on prior experience. The general requirements will be the same. The degree of independence and oversight will vary based on the candidate being determined to be a QEII or Sr QE. This position is responsible for applying and interpreting the applicable Quality Systems, developing and implementing Standard Operating Procedures and policies for an organization such as a quality control or manufacturing plant. The engineer develops and maintains schedules and timelines and 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 recommends opportunities for continuous improvement (internal/external). Responsibility for process validation across all media plants at a 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. Will support both internal and external audits.
Responsibilities
Monitor and trend quality indicators for purchased materials as well as manufactured and distributed components/products.
Assess Critical To Quality (CTQ) parameters and risk assessment variables as part of the decision‑making processes to support predictable product design and flow.
Own CAPA responsibilities and may lead the investigation/corrective action process.
Perform day‑to‑day QM engineering responsibilities for product and related operational areas.
Assure departmental compliance with ISO and FDA requirements through supporting plant trainings and initiatives.
Develop and implement process validation protocols and maintain validated status for equipment, facilities, and processes.
Use FMEA, risk analysis, validation, and project management tools such as sampling plans, Six Sigma, control plans, trending, and design control.
Initiate and/or support CAPAs and lead the investigation/corrective action process.
Support implementation of corrective actions and improvements by initiating and coordinating SAP data/documentation for current products.
Coordinate SAP master data and documentation for product changes and new products.
Drive continuous improvement in all areas and participate on Continuous Improvement teams, recommending improvements, implementing changes, and verifying effectiveness.
Perform all duties in accordance with BDDS Quality, Safety and Operating Procedures to support operations day‑to‑day.
Support internal and external audits and assist in administering the audit program.
Develop and maintain efficient methods for regularly reporting to management the current status of product quality with respect to quality objectives and goals, and provide plant quality metrics as required to generate quality system improvements.
Facilitate investigation of customer complaints, implement revision to TI's based on complaint analysis, and initiate preventative action plans and field action plans in response to valid customer complaints.
Define change control requirements for the plant related to manufacturing, facility and material changes, and provide full support to raw material changes assuring that all Quality Systems and requirements are met.
Qualifications
Required experience in independently writing and executing process validation protocols.
Experience in a medical device or pharmaceutical manufacturing facility.
Moderate knowledge and understanding of FDA 21 CFR 820 and ISO 13485.
Clinical Diagnostic experience is a plus.
Ability and skill to effectively manage multiple tasks and drive execution of change management plans.
Ability and skill to lead or manage process control, supplier quality and continuous improvement projects using statistical techniques/tools such as: statistical sampling, SPC.
Provide on‑site validations of equipment, software and materials for the Baltimore/Sparks reagent plants.
Develops, documents, administers and maintains Quality Systems for conformance, regulatory requirements and company policies.
Provides advice, updates, and troubleshooting to quality products 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, trending and design control.
Initiates and/or supports CAPAs and may lead the investigation/corrective action process.
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 to support operations day to day.
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.
Facilitates investigation of customer complaints. Implement revision to TI's based on the result of complaint analysis. Initiates preventative action plans and field action plans in response to valid customer complaints.
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.
Eligibility Criteria
To be considered for a Sr QE:
Bachelor's degree and 5 Years’ experience within the quality function or Master’s Degree with minimum of 3 years’ experience in quality.
To be considered for a QEII:
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.
About BD 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.
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 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.
Location and Shift Primary Work Location: USA MD – Hunt Valley. Additional Locations: Work Shift NA (United States of America).
Salary Range Information $73,300.00 – $121,000.00 USD Annual
Equal Opportunity Employer BD 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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Responsibilities
Monitor and trend quality indicators for purchased materials as well as manufactured and distributed components/products.
Assess Critical To Quality (CTQ) parameters and risk assessment variables as part of the decision‑making processes to support predictable product design and flow.
Own CAPA responsibilities and may lead the investigation/corrective action process.
Perform day‑to‑day QM engineering responsibilities for product and related operational areas.
Assure departmental compliance with ISO and FDA requirements through supporting plant trainings and initiatives.
Develop and implement process validation protocols and maintain validated status for equipment, facilities, and processes.
Use FMEA, risk analysis, validation, and project management tools such as sampling plans, Six Sigma, control plans, trending, and design control.
Initiate and/or support CAPAs and lead the investigation/corrective action process.
Support implementation of corrective actions and improvements by initiating and coordinating SAP data/documentation for current products.
Coordinate SAP master data and documentation for product changes and new products.
Drive continuous improvement in all areas and participate on Continuous Improvement teams, recommending improvements, implementing changes, and verifying effectiveness.
Perform all duties in accordance with BDDS Quality, Safety and Operating Procedures to support operations day‑to‑day.
Support internal and external audits and assist in administering the audit program.
Develop and maintain efficient methods for regularly reporting to management the current status of product quality with respect to quality objectives and goals, and provide plant quality metrics as required to generate quality system improvements.
Facilitate investigation of customer complaints, implement revision to TI's based on complaint analysis, and initiate preventative action plans and field action plans in response to valid customer complaints.
Define change control requirements for the plant related to manufacturing, facility and material changes, and provide full support to raw material changes assuring that all Quality Systems and requirements are met.
Qualifications
Required experience in independently writing and executing process validation protocols.
Experience in a medical device or pharmaceutical manufacturing facility.
Moderate knowledge and understanding of FDA 21 CFR 820 and ISO 13485.
Clinical Diagnostic experience is a plus.
Ability and skill to effectively manage multiple tasks and drive execution of change management plans.
Ability and skill to lead or manage process control, supplier quality and continuous improvement projects using statistical techniques/tools such as: statistical sampling, SPC.
Provide on‑site validations of equipment, software and materials for the Baltimore/Sparks reagent plants.
Develops, documents, administers and maintains Quality Systems for conformance, regulatory requirements and company policies.
Provides advice, updates, and troubleshooting to quality products 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, trending and design control.
Initiates and/or supports CAPAs and may lead the investigation/corrective action process.
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 to support operations day to day.
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.
Facilitates investigation of customer complaints. Implement revision to TI's based on the result of complaint analysis. Initiates preventative action plans and field action plans in response to valid customer complaints.
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.
Eligibility Criteria
To be considered for a Sr QE:
Bachelor's degree and 5 Years’ experience within the quality function or Master’s Degree with minimum of 3 years’ experience in quality.
To be considered for a QEII:
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.
About BD 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.
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 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.
Location and Shift Primary Work Location: USA MD – Hunt Valley. Additional Locations: Work Shift NA (United States of America).
Salary Range Information $73,300.00 – $121,000.00 USD Annual
Equal Opportunity Employer BD 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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