24 days old

Manager, Avitum Quality

B. Braun Medical Inc.
Bethlehem, PA 18018
  • Job Code
    125731121

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:

This position will have the responsibility to manage, plan, organize and direct the activities related to Quality Assurance function to ensure timely completion of the functional tasks. The Manager, Avitum Quality will manage the development and implementation of quality programs to maximize efficiencies and effectiveness of the function and budgetary resources necessary to support the business unit's goal while complying with regulatory and customer requirements. This position operates in accordance with company policies and procedures, FDA Regulations, ISO Standards and Canadian Medical Device Regulations, where applicable.

Responsibilities: Essential Duties

  • Oversees the performance of functional group to assure that products and processes meet company and regulatory requirements/standards.
  • Manages the operation of the Avitum business unit's quality management system.
  • Oversees the development of systematic approaches for assuring high quality goods and services that meet customer needs.
  • Responsible for, training, coaching and development of individuals to maintain and improve product quality and systems consistent with department and company operating objectives. Responsible for the motivation and development of personnel to optimize their performance and personal and professional growth.
  • Manages the operation of Avitum's Customer Complaint system and assures department employees compliance and strict adherence to the established procedures and policies. Monitors status of complaints.
  • Directs staff to continuously evaluate compliance with regulatory requirements.
  • Oversees the development of systematic approaches for assuring high quality goods and services that meet customer needs. Identify product quality improvement needs/opportunities and ensure that appropriate personnel address the issues.
  • Maintains oversight of product quality and establish correction and prevention action plans with appropriate functional groups. Develop and implement a system to follow up the action plans and assure that actions are completed and/or updated accordingly.
  • Provides technical assistance and direction to the other functional groups. Interface with regulatory agencies during routine audits, field complaint investigations and technical interchanges to present the company viewpoint.
  • Oversees and/or directs the investigation of excursions in supplied product quality or other related operations resulting in a discrepancy. Resolves nature of cause, impact, disposition and corrective actions.
  • Supervises the implementation of internal audit program and Corrective and Preventive Action program to determine any deficiencies in the Division as they relate to current regulations and assure timely corrective actions to resolve.
  • Create monthly service reports to determine trends and to provide feedback to Avitum and justifications supporting recommended actions to be taken.
  • Develops written procedures, for the business unit, ensuring that they comply with the requirements of the company, as well as industry standards and regulations.
  • Ensure the release of products manufactured by B. Braun within established timeframes required to meet company operating objectives.
  • Monitors the quality of products and implements systems and strategies to ensure product quality to established governmental regulations and company specifications. Coordinates the reporting of quality issues to management.
  • Ensure personal and department training in accordance with department training matrix.
  • Function as Management Representative.

Expertise: Knowledge & Skills

  • Strong knowledge of quality policies and thorough understanding of FDA Regulations and ISO Standards for medical device or pharmaceutical operations
  • Knowledgeable with CAPA, document control, product release, risk management, validation, design controls, and process development, monitoring and statistical control.
  • Experience interfacing with FDA and ability to effectively write audit responses, conduct root cause analysis, and document investigations, experience with product containment and conducting product recalls.
  • Must be able to work with all phases of company manufacturing and quality operations and have familiarity with requirements for submissions to regulatory agencies.
  • Strong management skills to effectively staff and manage relevant personnel and functions to assure that company goals and responsibilities are met.
  • Proficient with MS Office programs as well as other software programs
  • Strong communication skills, both written and verbal, with the ability to make verbal presentations to both small and large groups at a variety of levels both inside and outside of the company.
  • Ability to organize and oversee several projects at one time.
  • Strong time management skills.
  • Project management



Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

  • Bachelor's degree (BA/BS)
  • 6 8 years professional experience in Quality or related field
  • Minimum 2 years of supervisor or management experience
  • Minimum 5 years experience in quality systems documentation & administering FDA and ISO requirements.
  • Strong knowledge of quality policies and thorough understanding of FDA Regulations and ISO Standards for medical device or pharmaceutical operations
  • Business travel, driver's license, passport.
  • Travel to any B. Braun facility domestic and international may be necessary.

Desired:

  • Masters Degree
  • Experience in Medical Device field

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.



PI125731121
Posted: 2020-11-05 Expires: 2020-12-06

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Manager, Avitum Quality

B. Braun Medical Inc.
Bethlehem, PA 18018

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