Sr. Quality Engineer
Location:
Allentown , Pennsylvania
Posted:
October 23, 2017
Reference:
2017-10946
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 Engineering support for failure investigations, data trending and analysis, issue identification and resolution. Prepare reports for key quality metrics and lead continuous improvement efforts in Quality. Operate in accordance with company policies, procedures and regulatory requirements (FDA, ISO, MDD, CMDR, etc.).
Responsibilities: Essential Duties
  • Support Operations to resolve technical issues and implement corrective and preventive action for products.
  • Responsible for leading and executing root cause investigations, documenting results, and recommending corrective action for discrepancies resulting from a variety of technical problems of moderate to complex scope.
  • Detects assignable causes of variation and implements means to reduce or control effects of variation on process or product output.
  • Defines, implements and monitors metrics for key process indicators. Prepare and present trend reports to management.
  • Drive continuous improvement efforts through facilitating, leading, and collaborating with cross function teams.
  • Responsible for reviewing discrepancy reports to verify adequacy of root cause investigation, correction and corrective actions and ensure clear and concise conclusions.
  • Develop and maintain statistically valid sampling plans for various engineering studies, validations and quality inspections.
  • Provide quality and compliance direction, coaching and mentoring for company personnel.
  • Provides support during regulatory inspections and customer audits. Identify and implement quality system improvements when gaps are identified through audits and departmental reviews. Proactively investigates, identifies and implements improved efficient and compliant Quality standard work.
  • Ensure personal training in accordance with training plan.
  • Ensure operations within approved department budget.
  • Performs other related duties as required by management.
Expertise: Knowledge & Skill Requirements
  • Statistical sampling and quality control methods
  • Hypothesis testing
  • Design of experiments
  • CGMP's, QSR's, ISO, CMDR, and MDD
  • Risk Management and Hazard Analysis techniques
  • Data analysis
  • Excellent written and verbal communication, presentation and interpersonal skills
  • Ability to effectively manage multiple priorities and projects


Qualifications
Expertise: Qualifications - Experience/Training/Education/Etc
Required:
  • B. S. in Scientific discipline
  • 8+ years professional experience
  • 5+ years of Quality experience in the medical device / pharmaceutical industry
  • Strong understanding of quality policies, FDA Regulations and ISO Standards for medical device or pharmaceutical operations.
  • Strong knowledge of CAPA, risk management, root cause investigation, document control, validation, and design controls.
  • Strong knowledge in statistical process control and ability to apply advanced statistical techniques.
  • Demonstrated use of Quality tools, principles and methodologies including lean and six sigma principles.
  • Must be able to successfully work with all functional department and all phases of company manufacturing and quality operations
  • Travel to any B. Braun facility, domestic and internationally
Desired:
  • Advanced degree (M.S., M.B.A., Ph.D.)
  • Certified Quality Engineer
  • Six Sigma Black Belt
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:
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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