This is a full-time and direct-hire position. This position is ONSITE in Waltham, MA. No C2C or 3rd party or sponsorship currently. We appreciate all of our applicants, but we are not able to sponsor at this time.  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

• 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 Sigma methodologies as appropriate to achieve optimal results

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.

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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. [ Link removed ] - Click here to apply to Manufacturing Quality Engineer