Manager II, QA
Company: B. Braun Medical
Posted on: June 25, 2022
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
- 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 &
- 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
- 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
- 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
- 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
- Frequently:Sitting , Standing, Talking - ordinary, loud/quick,
- Constantly:N/A Environmental Conditions:
- Occasionally:Proximity to moving parts
- 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
- 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
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
Keywords: B. Braun Medical, Irvine , Manager II, QA, Executive , Irvine, California
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