Quality Systems Specialist II

  • B. Braun Medical Inc.
  • Irvine, CA, USA
  • Nov 11, 2017
Medical

Job Description


B. Braun Medical Inc.



Requisition ID 2017-11274
Company B. Braun Medical Inc
# of Openings 2
Job Locations US-CA-Irvine
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:

Responsible for establishing standardized and harmonized quality systems and processes for Irvine Operations that are compliant, efficient and effective and employ best practices in industry. Interface with all BBMI sites to ensure systems and processes are properly implemented and maintained for sustained compliance. Ensure quality and regulatory compliance requirements are identified, documented, integrated, and maintained to avoid gaps and ineffectiveness.



Responsibilities: Essential Duties
  • Solid understanding of the efficiencies and criticalities of all of the quality systems elements at BBMI. Work seamlessly with functional business groups to improve upon vertical and horizontal system interfaces and efficiencies.
  • Executes the strategic direction for Quality Systems Excellence Programs & Deployment Management. Understands quality and regulatory requirements and integrates these within the company's Quality Management System in accordance with system capabilities. Evaluates and implements system and process improvements to ensure that quality systems continue to meet regulatory requirements and expectations.
  • Partners with Quality Operations at all BBMI sites on quality objectives related to quality systems and processes. Serves as the site Quality project leader and centralized team member for these initiatives. Ensures that user requirements are properly defined and documented, systems are structured to meet established requirements, and training is effectively executed to all affected personnel prior to implementation.
  • Utilizes lean and six sigma approaches to quality system processes to ensure processes are not only compliant but also efficient and effective. Must be able to lead Kaizen events with diverse team members to achieve desired results within established time frames.
  • Implements and maintains the Corporate Operating Procedures and centralized processes and templates. Identifies and implements process improvement tools for Quality Systems to ensure the process requirements of Quality Compliance systems are integrated.
  • Creates standard informatics methods for introducing, updating, tracking and trending Quality Systems Metrics. Provides standard capabilities for storing information relevant to programs for which Quality Compliance is accountable.
  • Analyzes metrics and informatics to monitor the Irvine site quality system and compliance across all sites. Identifies system and process issues, concerns or improvement opportunities and leads resolution
  • Responsible for executing the Irvine site long-term strategy of the Company's Quality Systems, incorporating best practices while maintaining alignment to Company Objectives.
  • Ensures that Irvine's Quality System policies and procedures are developed, implemented and maintained in compliance with regulatory requirements (FDA, CGMP, QSR, ISO, CMDR, MDD, etc).
  • Keeps informed of all existing and new regulatory requirements and works with Quality Operations to ensure full compliance in the Company's Quality Systems.
  • Maintains a high degree of personal professional development through a combination internal and external training and participation in professional associations as appropriate.
  • Supports B. Braun affiliates on quality system and compliance matters, as required.
  • Serves as a key quality systems expert to functional business units and Quality Operations.

Expertise: Knowledge & Skills
  • Experience with quality assurance standards such as ISO, ICH, USP & GxP is preferred.
  • Data analysis; Understanding of informatics and analytics of quality systems
  • Statistical sampling methods
  • CGMP's, QSR's, ISO, CMDR, and MDD
  • Risk Management and Hazard Analysis techniques
  • Motivation methods
  • Knowledge of budgeting principles and general administrative practices


Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc



Required:
  • B.S. in Scientific discipline
  • 8+ years of developing Quality systems infrastructure or centralized processes experience in the medical device / pharmaceutical industry
  • 5+ years experience in a quality leadership role required
  • Leadership in partnering with Operations, R & D, Engineering, Sales and Marketing.
  • Experience in FDA inspections and strategy, cGMPs and an ability to interpret regulatory requirements
  • Ability to use sound scientific judgment in management of the facility to prevent regulatory action
  • Ability to understand and evaluate end-to-end value streams (R&D, supply chain, product realization, PLM)
  • Ability to proactively identify and anticipate risk of non-compliance in a dynamic environment
  • Project Management experience is required, including project initiation, team development, and achieving desired results on time and on budget.
  • Travel to any B. Braun facility, domestic and internationally, when necessary.
  • To keep abreast of changes in the regulations, interpretation of the regulations and revising internal practices and written procedures to comply with the regulatory requirements.

Desired:
  • Advanced degree (M.S., M.B.A.)


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 employee must occasionally lift and/or move up to 30 pounds.


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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