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

**Education and/or Work Experience Requirements:**

+ 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 5-7 years experience in Quality Assurance in an **ISO 9001** certified Quality Management System or equivalent

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

Kelly puts you in charge of your career, with access to cutting edge projects and technologies in
industry leading organizations. Top companies throughout the world have trusted Kelly as a premier
source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm
with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety
and flexibility of working on short term project engagements, or prefer contract-to-hire or direct
hire placement with our clients, apply with Kelly to explore opportunities that suit your specific
professional interests.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect with us on Facebook, LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.
Posted: 2019-08-09 Expires: 2019-09-09

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Quality Engineer II

Kelly Services
Marlborough, MA 01752

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