Global Quality Lead - Life Science:
Entegris

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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:

P eople
A ccountability

C reativity
E xcellence

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.

• 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.

• 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
• Strong analytical, problem-solving, project planning, and technical writing skills
• Ability to travel domestically and internationally on a semi-regular basis.

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.

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