Global Design Assurance Manager
Our client, a medical company is recruiting for a Global Design
Assurance Manager for their Galway site
This role will have the responsibility to assure the quality of
product design from development through manufacture and commercial
distribution for all new and upgrade products developed within a
business unit. The successful candidate will assure product designs
provide the necessary safety, efficacy, regulatory compliance and
customer satisfaction while balancing the need for speed to market for
new innovations as well as cost effectiveness.
A key accountability of this role is the ability to identify, assess
and mitigate risks in the design of products that have the potential
to result in significant business disruption including product recalls
and product liability issues. The role must develop and deliver a
robust system of Design Controls and build a talented team of design
quality professionals that can work effectively with the R&D and
Regulatory functions to execute design excellence. The Design
Assurance Manager is responsible to develop and implement a design
quality strategy that supports the overall quality strategy as well as
the key Business goals.
Key Responsibilities
? Responsible for implementing and maintaining the effectiveness of
the Design Controls system across Manufacturing plants.
? Direct the Design Assurance organizations based in our
Asia/European manufacturing sites.
? Develop and execute strategies to optimize Design Controls process
and ensure compliance and connectivity to the broader Abbott design
assurance process requirements.
? Provide design assurance oversight to all functions operating in
the New Product Introduction area.
? Define clear roles and responsibilities for all functions to ensure
effective execution of the design controls process (R&D, RA, PM,
Operations, Clinical).
? Ensure timely communication with VP of QA and Senior Leaders on
critical design quality issues that arise at any stage of the product
design process.
? Manage resources to support product launches, appropriately
matching skill set of individual direct reports to demands of
projects, prioritizing efforts, anticipating technical issues and
assuring successful project outcomes.
? Conduct/Coordinate regular and robust design reviews that provide
assessment of issues, risks, and resource requirements for all phases
of NPI projects.
? Ensure that product/process/package/label/Test Method designs and
associated documentation comply with applicable Regulations for
products distributed globally (US/OUS).
? Pro-actively monitor Post Market surveillance trends to ensure any
potential design issues are addressed as well as developing a closed
loop feedback system to the design process.
? Work closely with the R&D and Design Quality teams to ensure robust
new product launch planning and successful design transfer process.
? Design Controls SME and person directly responsible to represent
the unit with outside Regulatory authorities (FDA, NMPA, Notified
Bodies, MoH, WHO) on design quality.
? Participate in Regulatory Agency inspections and respond to queries
related to product design controls, change control and complaints.
? Collaborate with Regulatory Affairs and R&D to establish
appropriate product filing strategies and provide necessary product
documentation for submission.
? Establish and execute design control policies, procedures,
processes and principles to ensure robust product designs, appropriate
evaluation during development and document change controls compliant
with requirements.
? Collaborate with R&D in the development of Design test protocols
and study plans and ensure both test plans and reports are compliant
with all applicable regulatory requirements.
? Work with R&D to ensure that Product Test Methods are designed to
provide the appropriate challenge to products and validated
appropriately.
? Work with R&D to ensure successful and cost-effective product
scale-up and technology transfer from R&D to commercial manufacture.
? Establish a post launch review process that monitors new product
performance against the expected market performance and triggers
escalation/intervention as necessary.
? Develop design assurance processes, systems, and Staff, delivering
a high performing team that supports successful NPI execution across
all Sites.
Requirements
? Bachelor&#**Apply on the website**;s Degree -
Engineering/Science/Life Sciences - Post graduate degree desirable.
? Job requires extensive knowledge of Medical Devices and/or IVD
design and manufacturing as well as experience in a fast moving R&D
environment.
? Experience managing a design assurance team is essential and
preferably experience working with teams remotely.
? Proven track record of results managing projects in a highly
regulated environment.
? Strong Leadership capability and ability to influence change
balancing compliance with pragmatic problem solving.
? Proven track record in delivering successful NPI programs on budget
and on time.
? Proven track record in delivering Continuous Improvement programs.
? Must have strong technical ability and be articulate in message
delivery.
? Ability to work and interact with several cultures across various
time zones.
? Experience managing in an environment with changing priorities and
making appropriate risk based decisions in the face of uncertainty.
? Excellent written and verbal interpersonal skills to influence many
diverse internal and external stakeholders.
? Ability to present complex technical information to Senior
Management.
? 5 years plus experience in a QA/R&D 0r other Technical leadership
role in a regulated environment.
For further information on this DA Manager role please contact Deirdre
Finnerty on (phone number removed)/
Check out all our open jobs on our HERO Recruitment website -
https(url removed)
Please Note: Under its obligation under the Data Protection
legislation, HERO Recruitment will not forward your details to any
company without your prior approval Location: Not Specified
Global Design Assurance Manager
Our client, a medical company is recruiting for a Global Design
Assurance Manager for their Galway site
This role will have the responsibility to assure the quality of
product design from development through manufacture and commercial
distribution for all new and upgrade products developed within a
business unit. The successful candidate will assure product designs
provide the necessary safety, efficacy, regulatory compliance and
customer satisfaction while balancing the need for speed to market for
new innovations as well as cost effectiveness.
A key accountability of this role is the ability to identify, assess
and mitigate risks in the design of products that have the potential
to result in significant business disruption including product recalls
and product liability issues. The role must develop and deliver a
robust system of Design Controls and build a talented team of design
quality professionals that can work effectively with the R&D and
Regulatory functions to execute design excellence. The Design
Assurance Manager is responsible to develop and implement a design
quality strategy that supports the overall quality strategy as well as
the key Business goals.
Key Responsibilities
? Responsible for implementing and maintaining the effectiveness of
the Design Controls system across Manufacturing plants.
? Direct the Design Assurance organizations based in our
Asia/European manufacturing sites.
? Develop and execute strategies to optimize Design Controls process
and ensure compliance and connectivity to the broader Abbott design
assurance process requirements.
? Provide design assurance oversight to all functions operating in
the New Product Introduction area.
? Define clear roles and responsibilities for all functions to ensure
effective execution of the design controls process (R&D, RA, PM,
Operations, Clinical).
? Ensure timely communication with VP of QA and Senior Leaders on
critical design quality issues that arise at any stage of the product
design process.
? Manage resources to support product launches, appropriately
matching skill set of individual direct reports to demands of
projects, prioritizing efforts, anticipating technical issues and
assuring successful project outcomes.
? Conduct/Coordinate regular and robust design reviews that provide
assessment of issues, risks, and resource requirements for all phases
of NPI projects.
? Ensure that product/process/package/label/Test Method designs and
associated documentation comply with applicable Regulations for
products distributed globally (US/OUS).
? Pro-actively monitor Post Market surveillance trends to ensure any
potential design issues are addressed as well as developing a closed
loop feedback system to the design process.
? Work closely with the R&D and Design Quality teams to ensure robust
new product launch planning and successful design transfer process.
? Design Controls SME and person directly responsible to represent
the unit with outside Regulatory authorities (FDA, NMPA, Notified
Bodies, MoH, WHO) on design quality.
? Participate in Regulatory Agency inspections and respond to queries
related to product design controls, change control and complaints.
? Collaborate with Regulatory Affairs and R&D to establish
appropriate product filing strategies and provide necessary product
documentation for submission.
? Establish and execute design control policies, procedures,
processes and principles to ensure robust product designs, appropriate
evaluation during development and document change controls compliant
with requirements.
? Collaborate with R&D in the development of Design test protocols
and study plans and ensure both test plans and reports are compliant
with all applicable regulatory requirements.
? Work with R&D to ensure that Product Test Methods are designed to
provide the appropriate challenge to products and validated
appropriately.
? Work with R&D to ensure successful and cost-effective product
scale-up and technology transfer from R&D to commercial manufacture.
? Establish a post launch review process that monitors new product
performance against the expected market performance and triggers
escalation/intervention as necessary.
? Develop design assurance processes, systems, and Staff, delivering
a high performing team that supports successful NPI execution across
all Sites.
Requirements
? Bachelor&#**Apply on the website**;s Degree -
Engineering/Science/Life Sciences - Post graduate degree desirable.
? Job requires extensive knowledge of Medical Devices and/or IVD
design and manufacturing as well as experience in a fast moving R&D
environment.
? Experience managing a design assurance team is essential and
preferably experience working with teams remotely.
? Proven track record of results managing projects in a highly
regulated environment.
? Strong Leadership capability and ability to influence change
balancing compliance with pragmatic problem solving.
? Proven track record in delivering successful NPI programs on budget
and on time.
? Proven track record in delivering Continuous Improvement programs.
? Must have strong technical ability and be articulate in message
delivery.
? Ability to work and interact with several cultures across various
time zones.
? Experience managing in an environment with changing priorities and
making appropriate risk based decisions in the face of uncertainty.
? Excellent written and verbal interpersonal skills to influence many
diverse internal and external stakeholders.
? Ability to present complex technical information to Senior
Management.
? 5 years plus experience in a QA/R&D 0r other Technical leadership
role in a regulated environment.
For further information on this DA Manager role please contact Deirdre
Finnerty on (phone number removed)/
Check out all our open jobs on our HERO Recruitment website -
https(url removed)
Please Note: Under its obligation under the Data Protection
legislation, HERO Recruitment will not forward your details to any
company without your prior approval
We need : English (Good)
Type: Permanent
Payment:
Category: Others
