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13 days old

Quality Engineer II

Kelly Services
Marlborough, MA 01752
**Essential Duties and Responsibilities:**



The successful candidate will be responsible to provide Process/Quality Engineering support for new product development and manufacturing support for commercial products, working to ensure the development and supply of high quality products to our customers. Provide direction in the areas of **Design Controls & Risk Management** to cross-functional teams responsible for new product development or design changes. Product line support will be focused on filtration control systems (hardware and software).



Serve as a Subject Matter Expert for application **of Design Controls in accordance with regulatory expectations** (e.g., **Quality System Regulation, ISO standards, ASME BPE, CE, BPOG** etc.). Ensures the comprehensive completion of risk management, **Design Verification, and Process/Design Validation** activities for products and processes. Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other multi-functional product development team members.



Lead the effective deployment of Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.



Ensure active and thorough investigation of quality issues identifying root causes and implementing corrective actions. Identifies and controls manufacturing process defects (scrap, nonconforming material, customer complaints).



Ensure the development and validation of appropriate test methods for product and process performance



Effectively utilizes Lean and **Six Sigma** methodologies as appropriate to achieve optimal results



**Qualifications**



At a minimum, a **BA/BS degree** (in a Biological Science, Engineering, or Physical Science requires).



Experience with **electro-mechanical hardware** and associated control systems and HMI



Understanding of the basics of cell culture and filtration and chromatography operations in a bioprocess setting is required for this position



**Certified Quality Engineer** ( **ASQ CQE, CRE** or equivalent) preferred



Minimum of 3-5 years experience in Quality Assurance in an **ISO 9001** certified Quality Management System or equivalent



Please apply now with your most updated resume for immediate consideration!




**Why Kelly** **** **?**



Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-10-12 Expires: 2020-11-16

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Quality Engineer II

Kelly Services
Marlborough, MA 01752

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