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Manager II, Quality Investigation

Company: B. Braun - Allentown MFG
Location: Allentown
Posted on: January 16, 2022

Job Description:

B. Braun Medical Inc.Manager II, Quality InvestigationUS-PA-AllentownJob ID: 2021-19729Type: Regular Full-Time# of Openings: 1Category: QualityAllentown Mfg FacilityOverviewAbout 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 64,000 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 .ResponsibilitiesPosition Summary: Manages the investigations group for customer complaint investigations, supplier quality and quality engineering functions. Manages the site customer complaint and post market surveillance trends investigations. Assures that investigations processes for either internal or external sources are thorough and drive to root cause. Operates in accordance with company policies and procedures, FDA Regulations, ISO Standards and Canadian Medical Device Regulations, where applicable. Responsibilities: Essential Duties

  • Manages the work activities of employees engaged in customer complaint and Post Market Surveillance trends investigations (Internal and External) within the site.
  • Assure that controls are in place to effectively and accurately process customer complaints investigations and Post Market Surveillance investigations.
  • Assure timely escalation to site management when handling product safety and compliance issues.
  • Assure quality engineering support at Material Review Boards meetings.
  • Provide support to the functional groups within the company on customer complaints and investigations. Interface effectively with QA Corporate, Engineering, Manufacturing, Regulatory Affairs and other technical functions.
  • Ensure that all investigations are thorough, accurate and being conducted in a timely manner. Ensure that investigation files are properly maintained in accordance with company policies and procedures. Provide support during regulatory inspections and customer audits.
  • Monitor complaint activity within the site. Prepare and present trend reports to management. Communicate product complaint information internally with sales force, marketing functions, and operations, and externally with customers and regulatory bodies, where required, both verbally and in writing.
  • Internally support the Manufacturing Business Units to provide quality engineering support to post market surveillance quality trends or continuous improvement projects.
  • Assure Supplier Quality Agreements and/or Change Agreements are in place for approved site suppliers.
  • Ensure site suppliers comply with Quality Agreement and/or Change Agreements requirements.
  • Ensure thorough investigations and timely closure of supplier corrective actions.
  • Provide guidance and prioritize projects and workload for the quality engineering staff.
  • Assure all investigations from either internal or external sources are thoroughly investigated to root cause and trended across data streams in order to assess effectiveness of corrective and preventive actions.
  • Provide / formulate product disposition or other actions related to product nonconformance and field performance issues.
  • Assure risk assessment activities are properly applied throughout all quality investigations.
  • Provide risk assessment on product nonconformance and field performance issues.
  • Review Internal Audit (IA), Deviation, Out of Specification (OOS), and Supplier Corrective Action Notification (SCAN) responding reports.
  • Track and monitor site metrics related to the customer complaint and supplier corrective actions processes and develop and implement programs designed to increase department and company employee awareness.
  • Responsible for training, development, motivating and counseling of subordinate staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies. Effectively communicate a variety of personnel actions; e.g., employment, termination, performance and salary reviews, disciplinary actions, scheduling and/or approving overtime.
  • Ensure personal training in accordance with department training matrix.
  • Performs other related duties as required by managementExpertise: Knowledge & Skills
    • Knowledge of quality policies, FDA Regulations and ISO Standards for Pharmaceutical (21CFR 210 & 211) and Medical Device Quality System Regulations (21CFR 820), ISO 13485 and MDD.
    • Mastery of customer complaint handling requirements.
    • Must be able to work with all functional groups.
    • Strict attention to detail required. Problem detection ability a must.
    • Ability to act effectively as a team member to resolve problems.
    • Ability to effectively work with all functional groups.
    • Interface with a wide variety of disciplines to evaluate applicability of existing methods.
    • Excellent written and verbal communication and interpersonal skills
    • Proficient in the use of computers including a wide variety of word processing and spreadsheet software packages
    • Demonstrated customer relations skills.
    • Sufficient human relations skills to effectively staff and manage relevant personnel and functions to assure that company goals and responsibilities are met.
    • 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 simultaneously work on several projects with the flexibility to reprioritize in a minimum amount of time.
    • Ability to investigate and analyze technical and regulatory issues.
    • Knowledge in Industrial Statistic and its application to Pharmaceutical Manufacturing, Quality Control, and SPC. QualificationsExpertise: Qualifications - Experience/Training/Education/Etc Required:
      • 4 - 8 years professional experience with at least 2 years of supervisor experience.
      • Bachelor's Degree required, degree in Engineering or Science strongly preferred.
      • Minimum 6-8 years experience in quality systems documentation & administering FDA requirements.Desired:
        • Engineering background
        • Six Sigma Certification
        • Advanced degree or certificationsWhile 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. Additional Information 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.What We OfferB. 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

          Through its Sharing Expertise - initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.NoticesEqual Opportunity Employer Veterans/DisabledAll qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Keywords: B. Braun - Allentown MFG, Allentown , Manager II, Quality Investigation, Executive , Allentown, Pennsylvania

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