Senior Quality Engineer III

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 office.

Entegris is a values-driven culture and our employees rally around our core PACE values:

People
Accountability

C reativity
Excellence

The Role

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 inspections
• 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 goals.
• 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 test data.
• 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 processes.
• 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 needed.
• 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 preferred
• 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 methodology;
• Knowledge of ISO 13485 requirements and GMP regulations preferred
• 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 your goals.

• 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.

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