Quality Engineering Specialist

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

Responsibilities

Position Summary:

Provide Quality Engineering leadership to production for quality activities and maintain oversight of manufacturing activities for quality compliance, while assuring that products and process continue to operate in accordance with company policies and procedures.

Together with the Manufacturing, Technical Services, Quality Operations and QC Process Control teams, the incumbent of this position will be accountable for the performance of their assigned operational area against key business objectives such as safety, quality, compliance, and production costs/output. The incumbent will drive peers to manage performance of equipment, systems, and processes; and will work to improve the output, efficiency or quality of the associated manufactured products.

Responsibilities: Essential Duties

• Provide Quality Engineering ownership for assigned operational areas and critical GXP support functions, leading to acceptable Right-the-First-Time (RFT) levels for input, component, and finished good production.
• Accountable for ensuring quality investigations are completed in a timely and thorough manner per applicable investigation procedures and with minimal supervision. Drive investigations to reach product dispositions and recommend other quality compliance actions related to nonconformance and field performance issues.
• Participate in, facilitate and monitor effectiveness of Material Review Board actions to include product impact assessment, product correction, investigation, root cause analysis, identification and implementation of corrective and preventive actions as applicable. Monitor effectiveness of actions taken.
• Evaluate complaint samples received from customers to lead effective investigation. Level of support required is based upon product, technical and functional expertise.

• Establish process re-start and re-inspection protocols to support material dispositions, utilizing appropriate risk-based statistical sampling plans.
• Conduct Gemba Walks, promote quality culture, and be a QA liaison connecting other personnel to quality assurance, driving continuous improvement.
• Coach and mentor peers to instill a quality mindset by strictly following procedures, reporting issues and escalating as necessary to ensure compliance.
• Build and sustain a problem solving culture through coaching, mentoring, facilitating and using data driven root cause analysis with tools such as Fishbone Diagram, 5 Whys, Contradiction Matrix and others as necessary.
• Review and approve technical specifications and process control limits. Use a risk-based approach to criticality and Statistical Process Control (SPC).
• Support Change Control Requests (CCR) and Corrective Action Preventive Action (CAPA) projects, including providing QA impact assessments for assigned ownership areas.
• Provide technical recommendations to Management and high level technical personnel regarding product cGMP compliance, regulatory issues, validation strategy, and quality systems for projects, investigations, and strategic activities.
• Support production efforts and drive process improvements through the utilization of trend analysis, lean manufacturing principles, engineering studies, process and test method development and validation and statistical process control. Reduce process variability and mitigate root causes of defects.
• Create standard work and implement process improvement to reduce the incidence of product impacting discrepancies and/or minimize delays associated with discrepancy containment, investigation and immediate corrections.
• Monitor business performance through the use of leading Key Performance Indicators and supporting data trending. Take action to investigate and correct as trends shift.
• Represent the corporate quality vision, mission, and values, including but not limited to the ideals of continuous improvement, customer focus, personal accountability, integrity, honesty, teamwork, collaboration, and courage.
• Demonstrate and encourage a culture of quality by stopping processes when an issue is observed or reported with potential to impact safety, quality and/or compliance.
• Provides support during regulatory inspections and customer audits. Identify and implement quality system improvements when gaps are identified. Proactively investigates, identifies and implements improved Quality practices.
• Track and monitor metrics related to the production process. Drive the implementation of continuous process improvement initiatives designed to meet or exceed internal requirements. Prepare and present trend reports to management.
• Ensure personal training in accordance with department training matrix. Identify ongoing job specific and/or technical training needs to sustain competencies.
• Actively model, coach and engage employees to ensure safe conditions (ergonomics) and actions (behaviors) in all applicable functional work areas. Proactively correct identified hazards to prevent incidents and injury.
• Other duties assigned with or without accomodation.

Expertise: Knowledge & Skills

• Knowledge in US FDA cGMP and QSR as well as comparable international regulatory agency requirements for manufacturing and quality control.
• Knowledge in industrial statistics and its application to pharmaceutical manufacturing, Quality Control, and SPC.
• Excellent written and verbal communication and interpersonal skills
• Must be able to effectively manage multiple priorities and projects
• Ability to make verbal presentations to both small and large groups at a variety of levels both inside and outside of the company.

Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

• BS degree in an engineering or scientific discipline, or equivalent additional technical experience.
• Five (5) or more years of experience in a regulated industry (FDA preferred) in an engineering, investigations, or technical support/services position.
• Experienced with investigation, risk assessment, and root cause analysis tools
• Some business travel may be required.
• Work hours may include weekends and holidays.

Desired:

• Hands-on experience with manufacturing equipment, critical facility systems, clean rooms, product sterilization, GLP laboratories, or processes controls.
• Knowledge in application software supporting statistical data analysis, word processing, and project management.
• Familiarity and understanding of manufacturing methods related to Quality Control, including Engineering, Chemistry, Microbiology, and Sterilization.
• Certifications in Quality Engineering or Six Sigma methodologies

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

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 Equal Opportunity Employer Minorities /Women/ Veterans/Disabled

Through its "Sharing Expertise" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

Other Responsibilities: Other Duties

The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

Physical Demands:

• Moderate time will be spent in an office environment with substantial time spent on the production floor. Manufacturing areas are not climate controlled. During summer months, building exhaust fans provide ventilation but remain warm. Chemicals handled include acids and bases, organic solvents, and inorganic compounds. Chemicals may have characteristic odors or hazardous properties that require special handling and PPE. Potential exposure to allergens related to antibiotic medications may occur in the manufacturing or sample analysis areas.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

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.