Senior Quality Engineer - CAPA
Job Description



We are the people who give possibilities purpose
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.



Job Description
Position
Summary
The Senior Quality Systems Engineer – CAPA & Continuous Improvement serves as a subject matter expert (SME) for Quality Systems with primary
responsibility
for
the
Corrective
and
Preventive
Action
(CAPA)
process.
This
role
is
responsible
for
driving
CAPA
effectiveness,
improving
quality
system
performance,
and
ensuring
compliance
with
applicable
regulatory
requirements
and
company
standards.
The successful candidate will provide technical guidance, coaching, analytics, and continuous improvement support across the organization while partnering with cross-functional teams to ensure quality issues are
effectively
investigated,
corrective
actions
are
implemented,
and
quality
system
processes
continue
to
improve.
This
position
also
serves
as
a
key
resource
for
Quality
Systems
requirements,
root
cause
analysis,
compliance
initiatives,
and
quality
performance
reporting.
Key
Responsibilities
CAPA
Leadership
&
Quality
Systems
Serve
as
the
Subject
Matter
Expert
(SME)
for
CAPA
processes
across
the
organization.
Provide
guidance
and
coaching
on
investigations,
root
cause
analysis
methodologies,
corrective
actions,
CAPA
documentation,
and
effectiveness
verification
activities.
Monitor
CAPA
performance
and
ensure
corrective
action
plans
are
completed
accurately,
effectively,
and
on
time.
Analyze
process
nonconformances
and
support
the
development
and
implementation
of
corrective
and
preventive
actions.
Provide
leadership
and
support
for
the
timely
communication
and
escalation
of
significant
CAPA-related
issues
to
Quality
Leadership
and
Business
Unit
leaders.
Collaborate
with
Post
Market
Quality
to
ensure
timely
completion
of
nonconformance
escalation
activities
and
Situation
Analysis
reviews.
Apply
Quality
Systems
principles
including
CAPA,
document
control,
and
related
quality
processes
to
support
business
objectives.
Provide
work
direction,
mentoring,
and
support
to
CAPA
owners
and
project
teams
as
needed.
Data
Analytics
&
Reporting
Perform
data
analysis
related
to
CAPA
and
Quality
Management
System
(QMS)
performance
to
identify
trends,
risks,
and
improvement
opportunities.
Develop,
maintain,
and
present
quality
metrics,
KPIs,
dashboards,
and
reports
for
management
and
senior
leadership.
Utilize
statistical
tools
and
methodologies,
including
Six
Sigma,
Statistical
Process
Control
(SPC),
and
Design
of
Experiments
(DOE),
to
evaluate
process
effectiveness
and
support
data-driven
decision-making.
Support
CAPA
effectiveness
verification
activities
through
statistical
analysis,
sampling
methodologies,
and
objective
evidence.
Deliver
timely
and
meaningful
reports
to
senior
leadership
regarding
quality
system
performance
and
compliance.
Continuous
Improvement
Champion
continuous
improvement
initiatives
that
enhance
quality
system
effectiveness,
compliance,
and
operational
performance.
Collaborate
with
CAPA
stakeholders
across
multiple
sites
to
standardize
best
practices
and
drive
global
process
improvements.
Influence
cross-functional
teams
to
adopt
consistent
methodologies,
processes,
and
quality
tools
across
the
organization.
Implement
improvements
to
quality
systems,
processes,
and
documentation
to
increase
efficiency
and
effectiveness.
Support
innovation
and
quality
excellence
through
the
application
of
data-driven
problem-solving
methodologies.
Compliance
&
Quality
Programs
Support
the
development,
maintenance,
and
continuous
improvement
of
quality
programs
to
ensure
compliance
with
company
policies,
regulatory
requirements,
and
industry
standards.
Create,
review,
revise,
and
approve
Quality
System
documentation.
Ensure
compliance
with
approved
quality
methods,
Good
Documentation
Practices
(GDP),
and
quality
system
procedures.
Assist
with
internal
audits,
external
audits,
regulatory
inspections,
and
resolution
of
associated
findings.
Support
post-market
surveillance
activities
and
quality-related
projects
as
assigned.
Represent
the
Quality
organization
professionally
during
internal
and
external
interactions.
Participate
in
industry
and
professional
organizations
as
appropriate.
Assist
with
special
projects
and
perform
other
duties
as
assigned.
Required
Qualifications
Bachelor's
degree
in
Engineering,
Engineering
Technology,
Science,
or
a
related
technical
field.
Minimum
of
6
years
of
engineering,
quality,
or
quality
systems
experience.
Strong
understanding
of
quality
systems
regulations
and
standards,
including:
ISO
9001
ISO
13485
FDA
Quality
System
Regulations
(QSR)
EU
MDR
Experience
working
within
regulated
industries
such
as
medical
device,
pharmaceutical,
biotechnology,
or
similar
environments.
Ability
to
work
effectively
in
a
team-oriented
environment
and
deliver
on
cross-functional
objectives.
Experience
owning
or
managing
Quality
System
processes,
particularly
CAPA.
Preferred
Qualifications
Experience
driving
process,
product,
or
quality
system
improvements.
Experience
with
TrackWise
or
similar
electronic
Quality
Management
Systems
(eQMS).
ASQ
Certification
(CQE,
CSQE,
CQA,
or
related
certification).
Lean
Six
Sigma
Green
Belt
or
Black
Belt
certification.
Knowledge
&
Skills
Experience
with
electronic
CAPA
management
systems
(eCAPA).
Experience
managing
CAPA
processes
in
regulated
industries
such
as
medical
devices,
pharmaceuticals,
or
biotechnology.
Strong
root
cause
analysis
and
problem-solving
skills.
Advanced
Microsoft
Excel
capabilities,
including
Pivot
Tables,
charts,
reports,
queries,
and
data
analysis.
Strong
applied
statistics
knowledge
and
experience
using
statistical
tools
to
improve
process
capability
and
support
quality
investigations.
Understanding
of
sampling
methodologies
used
for
CAPA
effectiveness
verification.
Strong
understanding
of
auditing
principles
and
quality
compliance
requirements.
Ability
to
analyze
complex
data
and
translate
findings
into
actionable
recommendations.
Ability
to
present
data
and
recommendations
effectively
to
senior
leadership.
Extensive
knowledge
of
Quality
Management
Systems
and
cross-functional
business
relationships.
Excellent
communication,
collaboration,
and
influencing
skills.
Strong
organizational
and
project
management
capabilities.
Ability
to
work
independently
while
effectively
partnering
with
stakeholders
across
all
levels
of
the
organization.
What
Makes
You
Successful
Ability
to
lead
and
influence
quality
improvements
without
direct
authority.
Strong
analytical
mindset
with
a
passion
for
solving
complex
quality
issues.
Commitment
to
continuous
improvement
and
operational
excellence.
Ability
to
coach
and
mentor
others
on
CAPA,
investigations,
and
quality
system
requirements.
Strong
attention
to
detail
and
commitment
to
compliance.
Collaborative
approach
to
working
across
functions,
sites,
and
leadership
teams.
Why Join Us?
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
Required Skills
Optional Skills
.
Primary Work Location
USA GA - Covington BMD
Additional Locations
Work Shift
US BD 1st Shift 8am-430pm (United States of America)
