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 overall quality leadership and direction for the B. Braun Medical Inc. Active Device business, which includes design, development, manufacturing, distribution, field training, service, and post market surveillance activities. Lead the development and implementation of the Quality Systems and programs to ensure compliance with company policies and procedures, and industry regulations and standards, including FDA cGMPs, CFRs, ISO 13485:2003, MDD and CMDR. Manage the activities for Quality Assurance, Validation and Quality Control functions to maximize efficiencies of staff, equipment and financial resources to support company goals while ensuring compliance with company quality policies and applicable regulatory requirements. Interface with suppliers, customers and Regulatory Authorities regarding products and quality issues. Ensure compliance and inspection readiness of quality systems with applicable regulatory standards. Responsibilities: Essential Duties
Expertise: Knowledge & Skills
- Execute management responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Select, train, motivate and develop a technical staff with experience in a wide variety of disciplines to accomplish both the department's and the Operation's objectives. Responsible for the overall direction, coordination and evaluation of the reporting departments and functions.
- Collaborate with R&D, Operations and Marketing functions to develop Active Device business strategies and objectives for the U.S. and Canadian markets.
- Establish goals and objectives for Quality department that are consistent with business's Operations Objectives and Corporate Quality Objectives. Translate goals and objectives into personnel performance objectives.
- Ensure Quality Systems to support the lifecycle of B. Braun Medical Inc. Active Devices are established and maintained in harmony with Corporate Operating Procedures and in accordance with applicable standards and regulations. Report on the performance of the Quality Systems to Executive Management. Lead quality improvement efforts to further enhance quality systems, resolve quality issues, and mitigate compliance risk.
- Assure new products conform to design input requirements and requirements reflect user needs and expectations. Ensure new or modified products are qualified in accordance with applicable procedures prior to their release for distribution by B. Braun to customers. Oversee the product and process verification and validation program to confirm conformance to specifications. Monitor the quality of products and implement systems and strategies to ensure products continue to conform to established specifications and B. Braun expectations.
- Review, track and trend technical problems and quality issues, field complaints, field service, and supplier quality issues and ensure timely resolution of identified adverse trends or significant issues. Provide technical support and direction to other functional groups to determine root cause(s), products/materials affected, disposition of products/materials affected, implement both corrective and preventive actions, and monitor effectiveness of those actions.
- Lead the business during any regulatory agency inspection, field complaint inquiries and other interactions and ensure timely responses to any requests or issues which may be identified. Direct investigations for customer complaints and ensure appropriate documentation for responses to customers. Identify if field action such a product holds, product advisories and product recalls are needed for items already in use by customers. Interface directly with Regulatory Authorities to communicate and provide updates to B. Braun field actions.
- Support internal audit program and ensure timely implementation of corrective/preventive actions to the deficiencies in the entire operation as they relate to current regulations.
- Responsible for the collection, analysis and reporting of key performance indicators relative to the Quality function.
- Provide technical expertise and knowledge in Risk Management activities in all stages of product life cycle.
- Conduct periodic audits to ensure compliance to applicable regulations and inspectional readiness. Oversees site supplier management activities including supplier audits, certifications and monitoring.
- Function as Management Representative and chair Quality Management Reviews to ensure management involvement, visibility to quality issues, and proper quality oversight of site Operations.
- Develop and execute the budget/profit plan required to meet production and profit plan goals, and assure costs are maintained within constraints of budget.
Qualifications Expertise: Qualifications - Experience/Training/Education/Etc
- Statistical sampling plans and quality control methods
- Hypothesis testing
- Design of experiments
- CGMP's, QSR's, ISO, CMDR, and MDD
- General knowledge of human physiology
- Risk Management (ISO 14971) and Hazard Analysis techniques
- Data analysis
- Motivation methods
- Knowledge of budgeting principles and general administrative practices
- Thorough knowledge of management principles and supervisory practices
- Leadership - Must exercise leadership and move others to action; this includes peers and superiors, as well as subordinates. He/she needs to demonstrate a positive, results-oriented style by planning, motivating, organizing and controlling the work being done.
- Interpersonal Skills - Able to foster excellent relationships and credibility quickly at all levels of the organization, as well as the ability to create a partnership atmosphere with internal and external resources while achieving key operating objectives.
- Business Acumen/Competitive Knowledge - He/She needs to maximize opportunities and advantages and search for ways to leverage the current position.
- Integrity - A professional of unquestionable integrity, credibility and character who has demonstrated high moral and ethical behavior.
- Communication - Ability to develop and articulate an effective flow of ideas and information that generates an understanding and creates a climate in which others are informed and want to participate.
- Planning and Analysis Skills- He/She must have the ability to analyze and grasp an entire situation quickly from many perspectives and to create well-reasoned solutions. He/she needs to be conceptual, able to recognize problems from few or subtle clues and be innately comfortable with complexity. He/she should be able to demonstrate a probing, analytical approach.
- Training/Coaching Skills - Able to foster the professional development of subordinates through coaching/feedback on results, willing and able to share personal knowledge/experience and able to move decisively with performance problems.
- Maturity - Ability to be aggressive and confident, thus providing a good balance of risk taking and judgment.
- B. S. in Scientific discipline
- 10+ years of experience in the medical device industry
- Five years experience with software-controlled active medical devices
- Three years experience in a Quality leadership role required
- Five years experience in Quality Assurance
- In-depth knowledge of all Quality activities and regulatory requirements in the medical device industry.
- Ability to develop leaders and appropriately staff Quality organization to meet business needs and succession plans
- Financial acumen (e.g. budgetary, capital spending, etc.)
- Leadership in partnering with key strategic partners, including customers and suppliers
- Experience in FDA inspections and strategy
- Ability to use sound scientific judgment in management of the facility to prevent regulatory action
- Demonstrated track record in managing a large staff and establishing a clear, strategic direction
- Understanding of cGMP's and an ability to interpret and enforce regulatory requirements
- Advanced degree (M.S., M.B.A., Ph.D.)
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:
- Hazards: Employee may come in contact with occupational exposure to Bloodborne Pathogens (exposure to blood or other potentially infectious materials) and therefore will receive Bloodborne Pathogen training, in addition to being offered the Hepatitus B vaccination.
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.
One of the world's leading healthcare suppliers.