Quality Engineering Spec
Location:
Irvine , California
Posted:
October 20, 2017
Reference:
2017-10852
Overview
With a nationwide sales team and several manufacturing locations, B. Braun Medical has become a leading full-line supplier of healthcare products and services in the U.S. The company is committed to delivering innovative products and services with unmatched quality, superior technology, and cost-effectiveness, while maintaining environmental responsibility. Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. B. Braun employs over 4,500 people in the USA. B. Braun Medical Inc. began its operations in the USA in 1957. Initially, the company manufactured and sold disposable plastic syringes. During the 1980s and early 1990s, the company undertook several expansions and enlarged its product line of disposable medical devices. With the acquisition of McGaw, Inc. in 1997, including Central Admixture Pharmacy Services, Inc. (CAPS®), B. Braun dramatically broadened its product lines and services to U.S. customers.

U.S. Facilities and Operations:

Supporting product sales are a network of nationwide marketing and manufacturing locations. Bethlehem, Pennsylvania, is home to the U.S. Corporate Headquarters along with the marketing offices of the Hospital, Outpatient Markets (OPM), Renal Therapies, Vascular Interventional, International, and OEM Divisions. Central Admixture Pharmacy Services, Inc.(CAPS®) is also managed from this location. The nearby Allentown, Pennsylvania, facility manufactures Needle-free products, IV Safety Catheters, Anesthesia Systems, Introducers, Pharmacy Admixture products. Vascular products including Right Heart Catheters and Interventional Accessories are also manufactured in Allentown. The Irvine, California facility produces IV Solutions, Basic and Specialty Nutrition, Drug Delivery, and BTC products. Infusion Pump Systems are manufactured in Carrollton, Texas and IV administration and IV and Irrigation sets are produced in the Dominican Republic.

Responsibilities
Position Summary:
  • Provide quality assurance and quality engineering support to Pharmaceutical Manufacturing Operations.
  • Responsibilities: Essential Duties
  • Provide manufacturing line support, including but not limited to deviations, non-conforming product, complaint investigations and failure investigations.
  • Provide quality engineering project support, including but not limited to continuous improvement and sustaining engineering projects.
  • Serve as a multi-functional team member establishing quality requirements and providing guidance for sustaining engineering projects.
  • Lead or support Risk Management in accordance with quality standards and procedures, in evaluation of current products, as well as, new products being developed.
  • Develop and implement quality improvement programs.
  • Assess current operations for quality and compliance.
  • Develop methods to measure, validate and assure quality standards are achieved for applicable product lines.
  • Serve as a multi-functional team leader for quality improvement teams assuring commitments and objectives are achieved with positive results.
  • Lead cross-functional MRB team to track quality investigations, and product disposition status.
  • Lead or support Corrective Action Preventive Action (CAPA) projects, and root cause investigations for complaint and failure investigations.
  • Serve as lead or support for conducting internal Audits (IA), and Supplier Corrective Action Notifications (SCAN).
  • Provide technical recommendation for Management and high level technical personnel regarding quality considerations for projects and/or strategic activities.
  • Represent company in contacts with regulatory agencies, including interface with FDA inspectors.
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 Statistic and its application to Pharmaceutical Manufacturing, Quality Control, and SPC.


Qualifications
Expertise: Qualifications - Experience/Training/Education/Etc

Required:

  • BS degree in an engineering, or scientific discipline.
  • 8 or more years of experience in a pharmaceutical or medical device or other regulated industry [automotive, aerospace].
Desired:
  • Demonstrated knowledge within the areas of Industry Quality Control, Quality Assurance, and Validation.
  • Knowledge in application software supporting statistical data analysis, word processing, project management.
  • Familiarity and understanding of manufacturing methods related to Quality Control, including Engineering, Chemistry, Microbiology, and Sterilization Assurance.
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:
  • Some business travel may be required.
  • Work hours may include weekends and holidays.
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:
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.

A little about us:
One of the world's leading healthcare suppliers.

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