Sr Director, Quality Assurance Franchise (Med Dev)
Company: B. Braun Medical
Posted on: August 4, 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 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 . Responsibilities
Position Summary: Responsibilities: Essential Duties
- Responsible for Lead a team of direct and indirect quality
functions with accountability for the Medical Device Franchises
Quality Assurance and Compliance programs goals. Accountable to
ensure all products are designed and produced to meet
specifications, regulatory body, and BBMI standards.
- Support Business unit management to meet their division
objectives through the franchise quality goals.
- Represents the Corporate Quality voice in any Franchise
leadership strategy meetings, manufacturing plant reviews,
multi-functional meetings related to Medical Devices, and design
- In alignment with the Corporate Compliance team, manage the
franchises compliance program required portions of cGMP (QSR)
210/2011/820, Medical Device Regulation (MDR), Canadian Medical
Device Directive, CFDA, PMDA and other agencies.
- In alignment with the Corporate Quality Systems team, manage
and drive QMS compliance remediation as necessary.
- Oversee the franchise QA metrics (KPIs) to track Quality
initiatives and effect overall improvements QMS activity.
- Responsible for keeping the Corporate Quality and Business
management teams informed of quality status of products,
manufacturing sites, and key projects.
- Coordinate FDA required post-market surveillance programs with
Corporate Post Marketing Surveillance Department.
- Lead and manage investigations for product field actions and/or
recalls, as applicable.
- Facilitate driving a Quality culture and the Corporate strategy
for a single QMS into the Medical Device Operations team.
- Develop and maintain the Medical Device franchise quality
department budget, including manufacturing site resourcing for
daily operations and special projects.
- Lead and/or participate in multi-departmental and multi-site
teams to implement quality strategies.
- Represent BBMI with Regulatory Authorities related to product
and quality issues in the Medical Device franchise.
- Review and approve document changes for Quality Assurance
Departments as required.
- Ensure an understanding of the external regulatory requirements
with key franchise and business personnel, in order to adapt
product quality strategy accordingly. 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 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
- Directs the activities of a broad functional area through
division heads who are responsible for planning, budgeting, costs,
methods and employees.
- Determines actual organizational structure and allocation of
- Judgement is required in resolving complex problems based on
- Represents the organization as a prime contact on projects and
- Interacts with senior internal and external personnel on issues
often requiring coordination across organizational lines.
Expertise: Qualifications -Education/Experience/Training/Etc
- Bachelor's degree required, Master's degree preferred.
- 10-15 years related experience, plus a minimum of 7 years
management experience required.
- Regular and predictable attendance
- Occasional business travel required, Valid driver's license and
passport 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.
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,
- Constantly:N/A Activities:
- 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
- Constantly:N/A Environmental Conditions:
- 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, Other
- Constantly:Office environment 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, Allentown , Sr Director, Quality Assurance Franchise (Med Dev), Executive , Allentown, Pennsylvania
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