Associate Director, Design Assurance
Company: B. Braun Medical Inc.
Posted on: June 13, 2021
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: Essential Duties
- Lead, mentor, coach, and develop team of technical Quality
Assurance professionals who collaborate with R&D on the design,
development, and manufacturing transfer of new or changed medical
devices, active medical devices and pharmaceutical products
- Ensure appropriateness application of company policies and
procedures for pharmaceutical development / medical device design
controls, risk management, test method development, statistical
data analysis, and support of regulatory filings.
- Lead the continuous improvement of the quality system elements
that support the design, development, and manufacturing transfer of
- Maintain oversight of cGMP documentation, including, but not
limited to pharmaceutical development reports, design history
files, regulatory submissions, master batch records / device
history records, change control, validations, methods, and
- Ensure documents are thorough, accurate and compliant to
support regulatory inspections and submissions.
- Provide support for investigations and recommend, develop and
implement effective corrective actions.
- Provides support during regulatory inspections and customer
- Identify and implement quality system improvements when gaps
are identified through audits and departmental reviews.
- Proactively investigates, identifies and implements improved
- Ensure operations within approved department budget.
- Responsible for personnel actions including hiring, performance
management, and 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 breadth of professional field and industry
- Ability to integrate critical information and champion advanced
strategies/concepts through the organization.
- Drives development of advanced technologies, principles and
- Manages entry to intermediate level employees of a department
or a function with 1 or 2 sections.
- Ensures budgets, schedules, and performance requirements are
- 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.
Expertise: Qualifications -Education/Experience/Training/Etc
- Bachelor's degree required, Master's degree preferred.
- 10-12 years related experience required.
- Applicable industry/professional certification preferred.
- Regular and predictable attendance
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
Through its "Sharing Expertise" initiative, B. Braun promotes
best practices for continuous improvement of healthcare products
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.
While performing the duties of this job, the employee is
- 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,
- Occasionally:Climbing stairs/ladders, Push/pull, Reaching
upward and downward, Standing, Walking
- Frequently:Finger feeling, Hearing - ordinary, fine
distinction, loud (hearing protection required), Seeing - depth
perception, color vision, field of vision/peripheral, Sitting ,
Talking - ordinary, loud/quick
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
- Noise Intensity:Moderate
- Constantly:Office environment
Equal Opportunity Employer Veterans/Disabled
Keywords: B. Braun Medical Inc., Allentown , Associate Director, Design Assurance, Other , Allentown, Pennsylvania
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