Senior Quality Engineer III
Company: Entegris, Inc.
Posted on: May 3, 2021
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 its 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
Entegris is a values-driven culture and our employees rally
around our core PACE values:
Entegris is seeking a hands-on, innovative Senior Quality
Engineer to provide quality support for products and site
practices for the emerging Life Sciences business. The Quality
Engineer must be self-directed with the ability to work
collaboratively to complete projects and assignments, which will
include providing technical expertise and support for the Entegris
Aramus product lines. This role is based in our Billerica,
Ma high purity packaging manufacturing facility and reports to
the Life Sciences Quality Director.
In this role you will
- Reviews productions records, releases product and generates
Certificated of Analysis
- Coordinates/Supervises Incoming Inspectors, and floor product
- Leads product, process and customer issue resolution during all
phases of the product life cycle using tools such as 8D, Six Sigma
DMAIC and Statistical Process Control to ensure effective
corrective and preventive action and closure within timing
- Supports and maintains failure analysis process. Ensures
feedback, corrective action communication, and implementation are
consistent with customer expectations.
- Supports Bioburden, Endotoxin and Dose Audit monitoring
performed by Entegris or outside labs. Review, tracks and trend
- Review Cleanroom environmental monitoring data, may be required
to perform testing as a back-up. Perform investigation of Out of
specification results and impact on product.
- Generates, analyzes, and reports on the levels of product
quality within the assigned manufacturing areas, including Pareto,
Statistical Process Control, and Process Capability Studies.
- Participates in material disposition decisions to support
ongoing production for areas of responsibility.
- Participates in continuous improvement (Lean and Six Sigma
projects) within assigned manufacturing areas and quality
- Authors and/or reviews Standard Operating Processes, work
instructions, test specifications, Equipment/Cleanroom IQ/OQ/PQ
documents and other documents for accuracy.
- Supports ISO audits, customer and supplier audits as
- Ability to travel, both domestically and internationally to
support product and customer needs.
Traits we believe make a strong candidate
- Bachelor of Science degree or equivalent in technical or life
sciences discipline (engineering, materials, microbiology, ) with a
minimum 5 years of experience as a quality engineer in a
manufacturing environment; preferably medical device,
pharmaceutical or biopharmaceutical environment
- Experience with microbiological testing and aseptic technique
- Experience with applicable validations such as gamma
sterilization, biocompatibility and stability is desired
- Experience with applicable quality tools such as FMEA, SPC, DOE
and analysis tools such as: histograms, pareto, process mapping,
cause and effect diagrams, 8D problem solving & Six Sigma
- Knowledge of ISO 13485 requirements and GMP regulations
- Knowledge of ISO 9001 quality management systems
What we offer:
Our total rewards package goes above and beyond just a paycheck.
Whether youre looking to build your career, improve your health, or
protect your wealth, we offer generous benefits to help you achieve
- Very Competitive total compensation plans.
- A 401(K) plan to help you plan for your future with an
impressive employer match thats all yours- no vesting!
- Great health, dental and vision insurance packages to fit your
needs to ensure youre 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.
Keywords: Entegris, Inc., Billerica , Senior Quality Engineer III, Other , billerica, Massachusetts
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