B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.
Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.bbraunusa.com
Why this role matters:
As a Quality Engineer II, you will help protect product quality and patient safety across Aesculap’s broad medical device portfolio. In this on-site role, you will lead investigations, support validation and calibration activities, identify quality trends, and strengthen compliant distribution and operational processes in a highly regulated environment.
How you will make an impact:
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Train and educate associates on validation and compliance concepts, maintain the validation management program, and author and oversee execution of IQ, OQ, and PQ protocols and final reports in accordance with the Validation Master Plan and Matrix.
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Create clear, compliant quality documentation, including protocols, reports, work instructions, SOPs, quality plans, deviations, NCRs, set lists, product specifications, and set inspection plans for new and existing products.
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Lead CAPA, FMEA, risk analysis, and root-cause analysis activities; implement risk-management principles in accordance with ISO 14971; manage the St. Louis NCR process; and serve as the SME for NCRs during supplier, FDA, notified-body, and third-party inspections.
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Analyze, interpret, and present manufacturing, quality-control, and quality-metric data; serve as the SME for quality SAP functionality, QC inspection activities, and the development of acceptable quality limits.
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Review and approve drawings, calculations, specifications, rework documentation, process deviations, and other quality records while ensuring compliance with applicable ISO standards, FDA regulations, and the Quality Manual.
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Support process and equipment improvements across Aesculap facilities, including management of calibration and preventive-maintenance programs for quality instrumentation and equipment, and perform internal or supplier audits as needed.
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Represent Quality on new product and process project teams, providing tactical and strategic guidance to cross-functional teams, supporting audits and regulatory inspections, embodying the Company’s Vision, Mission, and Values, and completing other duties as assigned.
What sets you up for success:
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Bachelor’s degree in engineering, quality, life sciences, or a related field required.
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Five years+ of related quality experience in a regulated medical device, pharmaceutical, or biotechnology environment.
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Strong experience conducting investigations, root cause analysis, nonconformance management, and quality trend analysis.
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Working knowledge of validation and quality-system requirements; experience with calibration management, preventive maintenance, SAP, or data integrity is helpful but not required.
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Applicable industry or professional certification required.
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Sound judgment, problem-solving ability, adaptability, and the communication skills to work effectively across functions with general supervision.
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Regular and predictable attendance, occasional business travel, and the ability to work a non-standard schedule when needed.
What you will enjoy along the way:
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Meaningful work supporting approximately 15,000 medical devices used primarily in hospital operating rooms, including sterile containers and minimally invasive surgery equipment.
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A close-knit, on-site team culture that values open communication, practical problem solving, and collaboration.
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Opportunities to influence quality practices, support high-visibility improvement initiatives, and apply your expertise across a broad product portfolio.
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Excellent benefits package that includes healthcare coverage, a 401(k) plan, and tuition reimbursement.
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Vacation and sick time, plus paid holidays.
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A salary range of $83,834 to $125,751.
Physical demands and work environment:
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Light work, including exerting up to 20 pounds of force occasionally and up to 10 pounds frequently.
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Frequent sitting, finger dexterity, hearing, and speaking; occasional standing, walking, reaching, pushing, and pulling.
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Work is performed frequently in office, production/manufacturing, and laboratory environments, and occasionally in a warehouse environment.
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Moderate noise intensity with occasional proximity to moving parts; hearing protection may be required in designated areas.
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Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Additional information:
The responsibilities listed are representative and are not exhaustive. Management may add, modify, change, or rescind work assignments due to reasonable accommodation, business needs, or other reasons. Every employee is responsible for taking reasonable care of their own health and safety and that of others while at work.
The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.
B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.
Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here.