Manager II, QA

Company: B. Braun Medical
Location: Irvine
Posted on: June 25, 2022

Job Description:

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 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 . Responsibilities

Position Summary: This Manager II, QA will lead the quality engineering line support team and oversee the manufacturing processes. Identify any compliance gaps in the systems/processes, discrepancies trends and remediate them. Lead and/or support risk analysis activities. Ensure periodic reviews of discrepancies and trends. Oversee the quality assessment for change controls and provide oversight on validation activities at the site. Responsibilities: Essential Duties

• Manages programs and activities within the quality assurance functions of an organization.
• Administers policies and programs ensuring that organizational products and processes meet established quality standards.
• Participates in the development, implementation and administration of an organizational quality management system and monitors progress against strategic quality related goals.
• Manages the work of a team of analysts that collect data identifying potential quality failures, evaluate quality of raw materials or components, in progress goods, processes or operations, and implement and measure the impact of corrective actions.
• Solicits internal and external feedback with the goal of continuously improving processes or products.
• 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. General: It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons. Expertise: Knowledge & Skills
  • Requires full working knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles and concepts and integrates them to propose a course of action.
  • Manages entry to intermediate level employees of a department or a function with 1 or 2 sections. Ensures budgets, schedules, and performance requirements are met.
  • Judgement is required in resolving complex problems based on experience.
  • Contacts are primarily with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors. Preferred Requirements:
    • Pharmaceutical or Medical device experience. Qualifications
      
      Expertise: Qualifications -Education/Experience/Training/Etc Required:
      • Bachelor's degree required.
      • 08-10 years related experience required.
      • Applicable industry/professional certification preferred.
      • Regular and predictable attendance
      • Occasional business travel required, Ability to work non-stand schedule as needed 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. 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: 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:Reaching upward and downward, Push/pull
          • Frequently:Stand, Sit
          • Constantly:N/A Activities:
            • Occasionally:Climbing stairs/ladders, Reaching upward and downward
            • Frequently:Sitting , Standing, Talking - ordinary, loud/quick, Walking
            • Constantly:N/A Environmental Conditions:
              • Occasionally:Proximity to moving parts
              • 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:Moderate
                • Occasionally:Production/manufacturing environment, Warehouse environment
                • Frequently:Office environment, Lab environment
                • Constantly:N/A What We Offer 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
                  
                  Through its Sharing Expertise® initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. Notices
                  
                  Equal Opportunity Employer Veterans/Disabled All 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.
                  
                  
                  
                  
                  PI181272633

Keywords: B. Braun Medical, Irvine , Manager II, QA, Executive , Irvine, California