1+ months

NPI Quality Engineer

Kelly Services
Waltham, MA 02454
**Quality Engineer (NPI and Change controls)**

**Waltham MA or Malboro MA**

A growing Medical Device Manufacturing company is hiring a talented and experienced Quality Engineer


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

+ Experience with stainless steel and plastic device or consumable products and associated manufacturing processes.

+ Experience with **design controls is required**

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

**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 focus on **plastic and stainless-steel devices** and associated consumables used for **cell culture, filtration and chromatography** products.

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

+ 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** ).

+ Effectively utilizes **Lean and Six Sigm** a methodologies as appropriate to achieve optimal results

**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.

**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/nontraditional 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.
Posted: 2019-12-09 Expires: 2020-03-02

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NPI Quality Engineer

Kelly Services
Waltham, MA 02454

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