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Quality Engineer
Mansfield, MA, US
Engineering
Bachelors Degree
Full Time, Temporary
Experienced (Non-Manager)
On-site
Medical Devices and Supplies
First Shift (Day)
Mansfield, MA, US
Experienced (Non-Manager)
Full Time, Temporary
Medical Devices and Supplies
On-site
Engineering
Bachelors Degree
First Shift (Day)
Job details
Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting contract opportunity with one of our leading clients!
Title: Quality Engineer
Location: Mansfield, MA
Duration: 6 months +
Type: W2 contract (NO C2C OR THIRD PARTY)
Overview
- Will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle.
- Will utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision.
- Will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes.
- Support processes in base business and supervise, lead and mentor other engineers and technicians.
Responsibilities
- Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
- Work on non-conforming (NC) reports (Initiate, Analysis, Investigation, Review and close).
- Work with third party supplier to resolve issues with NC.
- Conduct Internal/Supplier Audits of the facility per ISO-1385 and/or 21CFR820
- Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
- Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
- Conduct investigation, bounding, documentation, review and approval of nonconformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
- Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
- Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
Required Qualifications
- Bachelor’s degree or equivalent with 8+ years of experience
- Master’s degree with 5+ years of experience
- Doctoral degree with 3+ years of experience
- Relevant experience working in manufacturing/operations.
- In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
- Experience with a proven track record of implementing appropriate risk mitigation.
- Certified Internal Audit to ISO-13485.
Additional Information
- Onsite / Monday – Friday / 8:30am – 5:00pm (can be flexible)
- Applicants must be legally permitted to work in the United States. Sponsorship is not available for this opportunity. OPT or H1B Visa is not being accepted at this time.
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Please contact Taryn Carbone (taryn.carbone@kellyengineering.com) for immediate consideration.
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Why Kelly® Engineering?
Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.