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Quality Engineer II

System One
Marlborough, MA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Title: Quality Engineer II

Location: Marlborough, MA

Schedule: Mon-Fri 8AM-4:30PM

Type: Direct Hire

Start date: ASAP


- Supports the New Product Introduction (NPI) team with deployment of Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle. Work with multi-functional product development teams

- This role is responsible for providing Process/Quality Engineering support for manufacturing including validation reviews and life cycle management

- Works independently to support the comprehensive completion of risk management (FMEA), Design and Process Verification activities for products and processes

- Assists in the development and validation of appropriate test methods for product and process performance

- Review of Equipment IOPQ’s in support of commercial operations


- BA/BS degree in a Biological Science, Engineering, or Physical Science requires

- Minimum of 5-7 yrs. exp. as a Quality Engineer in an ISO 9001 Quality Management System or equivalent

- Must have thorough understanding and working knowledge with Validation Principles and Concepts, Design Controls Processes in accordance with regulatory requirements (e.g., Quality ISO standards, ASME BPE, CE, BPOG, REACH, ROHS, WEEE etc.)

- Must have thorough understanding and working knowledge of quality engineering principles in support of new product development, continuous improvement and product/process change control

- Exp. with cell culture and filtration and chromatography operations in a bioprocess setting is required for this position

- Exp. with stainless steel and plastic device, systems/software and consumable products and associated manufacturing processes

- Proficient in utilizing Lean and Six Sigma methodologies as appropriate to achieve optimal results


Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services.  For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

System One


Marlborough, MA



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