Global Quality Engineering Lead
Company: entegris
Location: Billerica
Posted on: May 14, 2022
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Job Description:
Company Overview and Values Why work at Entegris? Lead. Inspire.
Innovate. Define Your Future. Not everyone who works for a global
company shares the same background, experiences and perspectives.
We leverage the differences of our employees to bring new ideas to
the table. Every employee throughout the company is encouraged to
share input on projects and initiatives. Our decision making
process is truly a collaborative effort as we realize there are
leaders at every level of the organization. We put our values at
the core of how we operate as an organization --- not just when
it---s convenient, but in a lasting and meaningful way. We want the
time and energy you spend here to have a positive impact on your
life inside and outside of the office. Entegris is a values-driven
culture and our employees rally around our core PACE values: People
Accountability Creativity Excellence The Role Our team in
Billerica, MA is seeking a Cross Business Unit (XBU) Global Quality
Lead to join our Life Sciences team in support of XBU manufacturing
activities. The hired individual in this role will be responsible
for planning, coordinating, and managing the team, manufacturing
projects and products to ensure continued compliance with internal
and applicable external quality regulations (i.e., Customer, United
State America Food and Drug Authorization, European Union Medical
Device Regulation). The new XBU Global Quality lead will partner
and collaborate with key internal and external stakeholders,
including New Product Development, Operations, Product Management,
Applications, and another associated personnel to ensure that the
XBU outputs meet defined requirements. This individual will oversee
all XBU projects, especially New Product Development, and be an
active member on project teams to provide appropriate Quality
support. This role includes development, implementation,
maintenance, and management of applicable XBU Global Quality
Metrics, Quality Plans, and continual improvement of the XBU Global
Quality for Life Science. In this role you will Lead and support
manufacturing to develop CE matrix (cause and effect matrix) and
identify Key Process Input Variables and Key Process Output
Variables for raw materials, manufacturing process, and final
products. Establish/release/review the manufacturing control plan
and Process Failure Mode Effect Analysis. Drive continuous
improvement in external and internal Defect Per Part Million. Work
closely with membrane and device engineering/manufacturing team/QA
lab to promptly address supplier/process/product/customer quality
issues through 8D, root cause analysis, and CAPA activities.
Address all types of Quality Notifications for process deviation,
internal and external customer quality complaints, raw material
defects, and audit gaps to improve safety, quality, and customer
satisfaction. Conduct/lead Material Review Board meetings to review
non-conforming materials, perform risk assessment, investigate root
cause, assign tasks for CAPA, and make lot disposition decisions.
Lead qualification and validation of membranes and filtration
products, to include Installation Qualification, Operational
Qualification, Performance Qualification, Factory Acceptance
Testing to implement change control for membrane/filter
manufacturing raw material changes, machine changes, component
changes, cycle time/yield improvements. Support and new product
(surface modified membranes/new life science sterile fitters)
qualification and validations throughout the new product
development cycle so that all design and development activity is
fully compliant with global Quality Management System (QMS)
standards/regulations. Lead/mentor/train Quality Engineers, Co-Ops,
and Process Engineers on QMS implementation, technical review,
statistical data analysis. Implement and review SPC using camLine
on raw materials, processes, final release, and SPC maturity
(Stargate). Collaborate with R&D, Engineering, manufacturing,
supplier quality, procurement, product management, application, and
lab groups in order to review, refine and enhance quality criteria
for membrane and filtration products. Perform process and supplier
audits. Work with customers to address their requests, questions,
concerns. Write white paper to customers for changes. Lead the
quality initiatives in life science for the validation of membranes
and filters. Support Hangzhou QMS and life science regulatory
implementation. Develop innovative approach to solve complicated
problems. Demonstrate excellence in every task performed. Traits we
believe make a strong candidate Minimum of 10 years quality
engineering/leadership experience within Life Science, specifically
within the medical device or Biopharmaceutical industry Experience
leading FDA inspections and FDA communications Experience working
with Notified Bodies and leading Notified Body audits Expert
knowledge and interpretation of 21 Code of Federal Regulation Part
820, 21 Code of Federal Regulation Part 210/211, European Union
Medical Device Regulation, ISO 13485, Medical Device Single Audit
Program, etc. Proven professional success and insight within
membrane and filtration engineering/manufacturing processes and
quality control approaches (extrusion, extraction, annealing,
surface modification for membrane, pleating, bonding, cleaning etc.
for filter) and related testing (Metals, Particles, retention,
shrinkage, tensile, etc.). Data-driven and detail-oriented mind set
and the ability to utilize statistical techniques such as T-Test,
ANOWA, Equivalence test, capability study, Gauge R&R, control
charts, correlations etc. Proven success in the development,
implementation, maintenance, and continual improvement of quality
management systems to satisfy all applicable regulatory
requirements Ability to work independently with minimal oversite
Ability to collaborate with cross-functional teams and build
relationships to drive results to meet business needs Excellent
communication, relationship, and leadership skills Positive
attitude Strong analytical, problem-solving, project planning, and
technical writing skills Bachelor---s degree required; Master---s
degree preferred. Ability to travel domestically and
internationally on a semi-regular basis. What we offer: Our total
rewards package goes above and beyond just a paycheck. Whether
you---re looking to build your career, improve your health, or
protect your wealth, we offer generous benefits to help you achieve
your goals. Very Competitive total compensation plans. A 401(K)
plan to help you plan for your future with an impressive employer
match that---s all yours- no vesting Great health, dental and
vision insurance packages to fit your needs to ensure you---re
happy and healthy. A progressive PTO policy that empowers our
employees to take the time they need to recharge At Entegris we are
committed to providing equal opportunity to all employees and
applicants. Our policy is to recruit, hire, train, and reward
employees for their individual abilities, achievements and
experience without regard to race, color, religion, sexual
orientation, age, national origin, disability, marital or military
status. Entegris strongly encourages all of its employees to be
vaccinated against COVID-19. At Entegris, COVID-19 vaccination is
preferred but not required at this time.
Keywords: entegris, Billerica , Global Quality Engineering Lead, Engineering , Billerica, Massachusetts
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