BD (Becton, Dickinson and Company) Staff Quality Engineer I in Hunt Valley, Maryland
Job Description Summary
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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.
Our vision for “function or BU” at BD
The position is responsible for overseeing validation practitioner activities for sterilization / sterility assurance initiatives including the following: ethylene oxide, radiation, moist heat, dry heat and aseptic processing.
An open position risks a gap in sterilization validation compliance and a delay in realizing production cost reductions and efficiency improvements for the Media plant.
About the role
The Staff Quality Engineer I is responsible for assuring the sterility of manufactured product labeled sterile and the cleanliness of products without a sterile claim. He/She would be making recommendations, and maintaining compliance to, the site sterility assurance program for all sterilization modalities, including ethylene oxide, radiation, moist heat, dry heat and aseptic processing; for interpreting ISO standards, corporate sterility assurance and sterilization policies and procedures and implementing local procedures and standard methodologies to comply those policies; project teams and functional groups; and guiding validation practitioners through planning, execution, and summary of studies. Additional responsibilities include representation on external strategic teams, give council to satellite facility associates, and interacting with regulatory and customer auditors.
Main responsibilities will include:
Extensive application of sterility assurance principles, theories, concepts, and quality sciences, tools, and systems with measurable / confirmed results.
Guide the successful completion of major sterility assurance programs and may function in a domain authoritative role.
Demonstrate outstanding experience with validation execution and effective deviation corrective / preventive action implementation.
Write and lead sterilization and sterility assurance validation activities including generating procedures and protocols for equipment, aseptic techniques, and environmental controls.
Ensure quality conduct of projects, including strategy development, data summary and interpretation, and completion report preparation, and review alignment to applicable laws and mentorship.
Review and approval of sterilization validations and re-qualifications in line with relevant site, corporate and/or ISO requirements.
Implement and communicate the strategic and technical direction for projects affecting sterility assurance within and among Media manufacturing facilities.
Identify any issues that may delay project achievements and recommend appropriate action to be taken.
Supervise, monitor and report sterility assurance metrics per corporate policy.
Act as liaison between site and Corporate Sterilization.
Coordinate periodic sterilization requalification/revalidation efforts with contract sterilizers; quarterly sterilization dose audits for sterile irradiated products; periodic requalification for ethylene oxide sterilized products.
Identify sterility assurance quality risks and develop solutions to mitigate risks to an acceptable level.
May be required to mentor and train other associates within the team in the area of sterilization, sterility assurance, contamination control, etc.
Support customer and regulatory audits of the Chemistry laboratory.¬†
Support site continuous improvement activities as appropriate.
Skills and Qualifications
Knowledge of Food and Drug Administration (FDA/21 CFR Part 820) and International Organization for Standardization regulations for medical devices (ISO 13485) is preferred
Effective written and verbal communications with clarity and consideration to a variety of audiences and situations
Reliably lead numerous projects/tasks and drive execution of organizational change plans
Ability to work within a multi-functional team environment and work closely with Management, Quality, Operations, Safety, Planning, Validation, Engineering, Maintenance, Regulatory Affairs, Industrial Affairs, Marketing, Corporate Sterilization, etc.
Results-oriented: Track record of shipping software to end users
Ability to commit to results and resolve opportunities in working teams is required
Awareness of safety practices, quality compliance, and software tools for documents and calculations is helpful
Industry Recognized certification in a Quality System Element specialty ¬†(e.g ASQ Certified Quality Auditor, Quality Manager, Quality Engineer) preferred
Experience or training with Six Sigma methodology and project management techniques is preferred
Versed with ISO sterilization/sterility assurance standards for radiation (ISO 11137), moist heat (ISO 17665), ethylene oxide (ISO 11135), dry heat (ISO 20857), cleanrooms (ISO 14644) and aseptic processing (ISO 13408) is preferred.
Experience conducting supplier audits (technical or quality systems) and/or internal audits is advantageous.
Bachelor’s degree in biomedical engineering or other related engineering / science field
Nine (9) years of proven experience in the medical device industry or Master’s degree with seven (7) years
Six (6) of the years are progressive experience in a specified area or five (5) years with a Master’s degree
Click on apply if this sounds like you!
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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.
Becton, Dickinson and Company is an Equal Opportunity Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.
To learn more about BD visit https://emea.jobs.bd.com/
Primary Work LocationUSA MD - Hunt Valley
Work ShiftNA (United States of America)
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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.