position in an exciting company.
JOB SUMMARY:
In this role, The Director/Senior Director of Customer Facing Quality,
will lead and build a dynamic CM/Medical Device wide team focused on
standardizing and deploying best in class Customer Facing quality
processes and communications. This person will lead the engagement and
interaction with key customers driving alignment on quality related
targets and goals. As a result, this person will deploy standardized
customer facing quality data management and reporting across all
CM/Medical Device sites.
This will require the use of highly capable, predictive, effective and
efficient quality related KPIs and metrics .
Essential
DUTIES AND RESPONSIBILITIES:
* Lead a global team of Quality personnel from across multiple sites
within the CM/Medical Device network.
* Develop and deploy a Customer Facing Quality strategy supporting
the overall strategic vision and goals of the CM/Medical Device
Quality, Commercial and Operational strategies.
* Liaise and support other customer facing leaders from across the
West functions.
* Develop and deploy standardized communication methods, tools and
process for quality engagement with customers.
* Engage and communicate directly with customers on quality related
matters driving a consistent and meaningful West Quality message.
* Leverage talent and experience across West to identify and deploy
standardized best in class customer facing quality processes across
CM/Medical Device sites.
* Develop tactics to drive rapid response to Customer issues.
* Organize and generate detailed quality information reports to show
credible and predictive trends driving identification and achievement
of customer related quality targets and goals.
* Develop and deploy in house predictive and effective measures of
customer quality allowing early identification and mitigation of
issues.
* Create repeatable methods to assess, measure and communicate the
overall effectiveness of the customer complaint handling process.
* Work with project managers, engineering team, and platform
management to develop plans to implement Quality Improvement Program
(QIP) workstream activities.
* Work within Quality or across West Divisions to triage Customer
Operational difficulties, define root cause(s), and coordinate the
implementation of corrective and preventive actions to preclude
recurrence.
* Manage or contribute to both corporate and facility driven
initiatives intended to meet defined objectives.
* Communicate to global Quality leadership issues that impact product
quality, safety or efficacy, compliance or business continuity which
have arisen via local customer complaints.
* Introduce and implement strategic business initiatives with
supporting functions that will help to ensure the external supply
chain is capable of meeting expectations from a quality, delivery and
cost perspective.
* All other duties as required.
BASIC QUALIFICATIONS:
* Bachelor&#**Apply on the website**;s degree in Science,
Engineering, or related field
* Experience : **Apply on the website** years
Preferred
KNOWLEDGE, SKILLS AND ABILITIES:
* Minimum of **Apply on the website** years&#**Apply on the
website**; experience in pharmaceutical or medical device environment;
minimum 8 years&#**Apply on the website**; experience in a Quality
role; ASQ CQE certification desirable.
* Deep knowledge of quality processes such as CAPA, complaint
management, risk management, root cause analysis, statistical sampling
plans, FMEA/Fault Tree Analysis, Design Optimization using DOE,
Hardware Reliability, Software Reliability, and Design Controls
including Design Verification/Validation.
* Knowledge of ISO **Apply on the website**:**Apply on the website**,
ISO **Apply on the website**: **Apply on the website**, **Apply on the
website** CFR **Apply on the website**, **Apply on the website** CFR
**Apply on the website** & **Apply on the website**, cGMP, cGLP
* Demonstrates the ability to lead and navigate in a global
organization with a broad scope and high level of complexity.
* Leadership ability to develop and implement organizational and
functional strategy. Initiates, sponsors and implements change and a
demonstrated track record in QA involvement.
* Demonstrate innovativeness in tactical matters relating to
proposing alternate solutions for process improvement.
* Works effectively with cross functional teams to produce innovative
solutions. Demonstrates Initiative, ability to efficiently prioritize
and manage multiple projects.
* Experience in FDA regulated environment, pertinent to ISO **Apply
on the website** is preferred
*
_EXPERIENCE WITH_ SAP is preferred
*
_EXPERIENCE WITH_ Lean Sigma programs and activities
We&#**Apply on the website**;re looking for a candidate to fill this
position in an exciting company.
JOB SUMMARY:
In this role, The Director/Senior Director of Customer Facing Quality,
will lead and build a dynamic CM/Medical Device wide team focused on
standardizing and deploying best in class Customer Facing quality
processes and communications. This person will lead the engagement and
interaction with key customers driving alignment on quality related
targets and goals. As a result, this person will deploy standardized
customer facing quality data management and reporting across all
CM/Medical Device sites.
This will require the use of highly capable, predictive, effective and
efficient quality related KPIs and metrics .
Essential
DUTIES AND RESPONSIBILITIES:
* Lead a global team of Quality personnel from across multiple sites
within the CM/Medical Device network.
* Develop and deploy a Customer Facing Quality strategy supporting
the overall strategic vision and goals of the CM/Medical Device
Quality, Commercial and Operational strategies.
* Liaise and support other customer facing leaders from across the
West functions.
* Develop and deploy standardized communication methods, tools and
process for quality engagement with customers.
* Engage and communicate directly with customers on quality related
matters driving a consistent and meaningful West Quality message.
* Leverage talent and experience across West to identify and deploy
standardized best in class customer facing quality processes across
CM/Medical Device sites.
* Develop tactics to drive rapid response to Customer issues.
* Organize and generate detailed quality information reports to show
credible and predictive trends driving identification and achievement
of customer related quality targets and goals.
* Develop and deploy in house predictive and effective measures of
customer quality allowing early identification and mitigation of
issues.
* Create repeatable methods to assess, measure and communicate the
overall effectiveness of the customer complaint handling process.
* Work with project managers, engineering team, and platform
management to develop plans to implement Quality Improvement Program
(QIP) workstream activities.
* Work within Quality or across West Divisions to triage Customer
Operational difficulties, define root cause(s), and coordinate the
implementation of corrective and preventive actions to preclude
recurrence.
* Manage or contribute to both corporate and facility driven
initiatives intended to meet defined objectives.
* Communicate to global Quality leadership issues that impact product
quality, safety or efficacy, compliance or business continuity which
have arisen via local customer complaints.
* Introduce and implement strategic business initiatives with
supporting functions that will help to ensure the external supply
chain is capable of meeting expectations from a quality, delivery and
cost perspective.
* All other duties as required.
BASIC QUALIFICATIONS:
* Bachelor&#**Apply on the website**;s degree in Science,
Engineering, or related field
* Experience : **Apply on the website** years
Preferred
KNOWLEDGE, SKILLS AND ABILITIES:
* Minimum of **Apply on the website** years&#**Apply on the
website**; experience in pharmaceutical or medical device environment;
minimum 8 years&#**Apply on the website**; experience in a Quality
role; ASQ CQE certification desirable.
* Deep knowledge of quality processes such as CAPA, complaint
management, risk management, root cause analysis, statistical sampling
plans, FMEA/Fault Tree Analysis, Design Optimization using DOE,
Hardware Reliability, Software Reliability, and Design Controls
including Design Verification/Validation.
* Knowledge of ISO **Apply on the website**:**Apply on the website**,
ISO **Apply on the website**: **Apply on the website**, **Apply on the
website** CFR **Apply on the website**, **Apply on the website** CFR
**Apply on the website** & **Apply on the website**, cGMP, cGLP
* Demonstrates the ability to lead and navigate in a global
organization with a broad scope and high level of complexity.
* Leadership ability to develop and implement organizational and
functional strategy. Initiates, sponsors and implements change and a
demonstrated track record in QA involvement.
* Demonstrate innovativeness in tactical matters relating to
proposing alternate solutions for process improvement.
* Works effectively with cross functional teams to produce innovative
solutions. Demonstrates Initiative, ability to efficiently prioritize
and manage multiple projects.
* Experience in FDA regulated environment, pertinent to ISO **Apply
on the website** is preferred
*
_EXPERIENCE WITH_ SAP is preferred
*
_EXPERIENCE WITH_ Lean Sigma programs and activities
We need : English (Good)
Type: Permanent
Payment:
Category: Others
