Quality Engineer

US-MN-Bloomington
Job ID
2017-4717
Category
Manufacturing
Shift
1st

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

Overview

Entegris is seeking a hands-on, innovative 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 Bloomington, MN high purity packaging manufacturing facility and reports to the site Quality Manager.

Responsibilities

  • Performs Bioburden and Endotoxin product release testing;
  • Performs Cleanroom environmental monitoring;
  • Maintains Laboratory equipment and testing supplies;
  • 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;
  • 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.
  • 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, and other documents for accuracy.
  • Supports ISO certification, customer and supplier audits as a subject matter expert, as needed.
  • Reviews productions records, releases product and generates Certificated of Analysis
  • Ability to travel, both domestically and internationally to support product and customer needs.

Qualifications

  • 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 pharmaceutical or biopharmaceutical environment;
  • Experience with microbiological testing and aseptic technique required;
  • Experience with applicable validations such as gamma sterilization, biocompatibility and stability;
  • 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;
  • Quality Engineer certification (CQE), Six Sigma Green or Brown Belt or similar quality certification;
  • Knowledge of ISO 13485 requirements and GMP regulations is helpful;
  • Knowledge of ISO 9001 quality management systems.

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.

 

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