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Assoc Dir, Quality-Act Med Dvc

B. Braun

This is a Full-time position in Carrollton, TX posted August 16, 2020.

Overview About B.

Braun B.

Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry.

Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis.

The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety.

B.

Braun Medical is headquartered in Bethlehem, Pa., and is part of the B.

Braun Group of Companies in the U.S., which includes B.

Braun Interventional Systems, Aesculap® and CAPS®.

Globally, the B.

Braun Group of Companies employs more than 61,000 employees in 64 countries.

Guided by its Sharing Expertise® philosophy, B.

Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs.

To learn more about B.

Braun Medical, visit www.BBraunUSA.com .

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 Responsible for all quality functions within organization.

Develops and implements strategies for ensuring that organizational products and processes meet established quality standards.

Establishes or administers an organizational quality management system and monitors progress against strategic quality-related goals.

Identifies potential quality failures, establishes methods for evaluating quality of raw materials or components, in
– progress goods, processes or operations, and oversees development and implementation of corrective actions.

Solicits internal and external feedback with the goal of continuously improving processes or products.

May represent the organization during external inspections or audits.

Responsible for personnel actions including hiring, performance management, termination.

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

Expertise: Knowledge & Skills Requires breadth of organizational, professional field, and industry knowledge.

Ability to integrate critical information from several diverse areas.

Champions advanced strategies and concepts.

Manages activities of a functional area which has at least 2 departments or major functions through managers and/or experienced employees.

Responsible for cost, method, and employee results Judgement is required in resolving all day-to-day problems.

Contacts are primarily with department supervisors, leads, subordinates, and peers.

Frequent contact with external contractors/vendors.

Qualifications Expertise: Qualifications
– Experience/Training/Education/Etc Required: Bachelor’s degree required, Master’s degree preferred.

10-12 years related experience required.

Applicable industry/professional certification preferred.

Occasional business travel required Regular and predictable attendance Desired: N/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.

B.

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 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.

While performing the duties of this job, the employee is expected to: Light work
– Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.

Lifting, Carrying, Pushing, Pulling and Reaching: Occasionally:N/A Frequently: Stand, Sit Constantly: N/A Activities: Occasionally: Climbing stairs/ladders Frequently: Hearing
– ordinary, fine distinction, loud (hearing protection required), Seeing
– depth perception, color vision, field of vision/peripheral, Sitting , Standing, Talking
– ordinary, loud/quick, Walking Constantly: N/A Environmental Conditions: Occasionally: N/A Frequently: N/A Constantly: N/A 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.

Noise Intensity: Low Occasionally: Production/manufacturing environment, Warehouse environment, Lab environment Frequently: Office environment Constantly: N/A Notices Equal Opportunity Employer Veterans/Disabled