B. Braun

Sr Quality Engineer

US-CA-Irvine
Requisition ID
2017-11421
Company
B. Braun Medical Inc
# of Openings
1
Category
Quality
Position Type
Regular Full-Time
Shift
8am - 5pm
Site
Irvine, CA

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 existing Pharmaceutical Manufacturing Operations.

Responsibilities: Essential Duties

  • Provide / formulate recommendations for product disposition or other actions related to product nonconformance and field performance issues.
  • Responsible for performing/supporting quality investigations in a timely and thorough manner per applicable investigation procedures.
  • Responsible to review and approve quality investigations to ensure documentation is complete, accurate and timely.
  • Establish investigation and re-start protocols to support product/sub-component disposition utilizing appropriate statistical sampling plan.
  • Provide risk assessment on product nonconformance and field performance issues.
  • Establish process control limits utilizing Statistical Process Control (SPC)
  • Support Corrective Action Preventive Action (CAPA) projects and investigation of root cause for Product Investigation Report (PIR).
  • Review Internal Audit (IA), Deviation, Out of Specification (OOS), and Supplier Corrective Action Notification (SCAN) responding reports.
  • Provide technical recommendation for Management and high level technical personnel regarding product cGMP compliance, regulatory issues, validation strategy, and quality systems for projects and/or strategic activities.
  • Interface with Engineering, Manufacturing, Regulatory Affairs, Research & Development, and other technical disciplines to represent QA in project teams, with the objective to assure that project quality objectives are met.
  • 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.
  • Five (5) years of experience in a pharmaceutical Engineering position.
  • Hands-on experience in pharmaceutical equipment and processes.
  • Six Sigma Certification
  • Some business travel may be required. Work hours may include weekends and holidays.

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:

  • Other duties as assigned with or without accommodation.

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:

  • Some 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.

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.

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