Quality Engineer I - Remote Job Listing at Kelly Services in Mechanicsville, VA (Job ID 9558371)

Description

At Kelly® Science, Engineering, Technology & Telecom (SETT), we're passionate about helping you find a job that works for you. How about this one? We're hiring a remote Quality Engineer I. With us, it's all about finding the job that's just right.

Quality Engineer I
Remote (EDT hours)
Starting Pay: $65K+ ($31/hr + DOE)
Full Benefits & Paid Time Off

The primary focus and purpose of this position is to lead the necessary on-going activities required to support new product development and existing products and processes. These activities include but are not limited to: Ensuring compliance to quality system requirements, supporting global risk management, design control and change management activities, analyzing post market metrics to identify potential adverse trends, develop and support continuous improvements projects, implementing proactive quality activities into the manufacturing plants, evaluate process changes as it relates to quality initiatives and objectives; provide general QA support to OMI operated manufacturing facilities and supply base.

Job Overview and Expectations:

• Ensure that all elements of the corporate Human Resources Development and Diversity policy are fully supported as appropriate for the position.
• Manage self and/or team in accordance with the expected IDEAL behaviors.
• Understand the Global Quality Objectives and Team Strategies.
• Provides technical leadership in solving technical problems related to quality issues and technologies.
• Develops, initiates and implements new quality concepts, tools and strategies to improve business practices.
• Solves technical problems, provides expertise in related specific field of knowledge and consults on issues and projects.
• Assists with the transfer of knowledge of technical skills and is viewed as a Subject Matter Expert.
• Understand the complaint trends and complaint reduction strategies by product family.
• Actively participate in and/or facilitate the development of deliverables required for medical device change control and product development.
• Actively participate in product development plans, specifically components that focus on design reviews, quality plans, design transfer, and design verification/validation.
• Direct all activities necessary for the project team to achieve design control and change control deliverables, specifically deliverables related to product safety and performance.
• Lead and ensure compliance to all risk management requirements.
• Partner within cross functional teams to determine root cause and mitigations of product issues as they arise during the product life cycle.
• Actively participate in the development of statistical plans and rationale for change control and design control activities/requirements.
• Where appropriate, incorporate the concepts of Lean Six Sigma to solve product/ process nonconformance issues.
• Lead or participate in and/or facilitate in monthly complaint review meetings (as needed).
• Lead the GPMS Reviews reports data compilation and analysis.
• Active participation in risk analysis on incident escalations to management.
• Participate in internal and external audits as needed.

Required Qualifications:

• Minimum of 5 years of collective experience in product development and quality in a medical device environment and medical device manufacturing practices.

• Minimum of 3 years developing and improving, efficient and effective product development processes.
• Experience with ISO standards – quality system design related to design control or risk management processes (ISO 14971).
• B.S. in Engineering, Science or Statistics.
• Must have home Internet & capability to work from home/remotely and support primarily EDT hours, with some flexibility.

Preferred Skills and Knowledge:

• Medical device GxP & ISO Standards proficiency.
• Product/process/system validations – demonstrated proficiency.
• Design Control – demonstrated proficiency.
• Risk analysis/assessments – demonstrated proficiency.
• Preferred: Certified Six Sigma Black Belt, Lean Enterprise, Design for Six Sigma.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Engineering/Technology – Project Services?

Looking to work with leading project management organizations at top companies around the world? That's where we come in. At Kelly Engineering and Kelly Technology, our Project Services Teams create expert talent solutions to solve the world's most critical challenges. We connect you with opportunities to work on intriguing, innovative, and high-visibility projects—all with a schedule that works for you. Do you prefer the variety and flexibility of short-term projects? Or are looking for a long-term opportunity? Either way, our connections and expertise will help you take your career exactly where you want to go. That's just good planning.

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.

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