Description
Quality Engineer
Kelly Services is currently seeking a Quality Engineer for one of our top clients in Mechanicsville, VA.
Summary:
- The Quality Engineer position focuses on leading activities to support new product development and existing products/processes.
- Responsibilities include ensuring compliance with quality system requirements, supporting global risk management, design control, and change management activities, analyzing post-market metrics, developing continuous improvement projects, implementing proactive quality activities in manufacturing plants, evaluating process changes, and providing general QA support to manufacturing facilities and the supply base.
Essential Job Functions:
- General Expectations and Accountabilities: Support corporate Human Resources Development and Diversity policy.
- Manage self/team in alignment with IDEAL behaviors.
- Understand Global Quality Objectives and Team Strategies.
- Provide technical leadership in solving quality-related technical problems.
- Develop and implement new quality concepts, tools, and strategies.
- Solve technical problems and consult on issues/projects as a Subject Matter Expert.
- Understand complaint trends and reduction strategies by product family.
Position Specific Accountabilities:
- Participate in/facilitate deliverables for medical device change control and product development.
- Engage in product development plans, focusing on design reviews, quality plans, design transfer, and design verification/validation.
- Direct activities to achieve design control and change control deliverables related to product safety and performance.
- Ensure compliance with risk management requirements.
- Collaborate with cross-functional teams to determine root causes and mitigations for product issues.
- Develop statistical plans for change control and design control activities.
- Apply Lean Six Sigma concepts to address product/process nonconformance issues.
- Lead or participate in monthly complaint review meetings.
- Lead GPMS Reviews reports data compilation and analysis.
- Participate in risk analysis on incident escalations to management.
- Engage in internal and external audits as needed.
Key Relationships/Customer Expectations:
- Collaborate with various departments, including Operations Quality, Quality Systems, R D, Medical Science, Marketing, Legal, Market Research, External Consultants, Vendors, Finance, and Product Supply.
- B.S. in Engineering, Science, or Statistics.
- Minimum of 5 years of experience in product development and quality in a medical device environment.
- Minimum of 3 years of experience developing and improving product development processes.
- Experience with quality system design related to design control or risk management processes ISO 14971 .
- Knowledge, Skills Abilities: Proficiency in medical device GxP ISO Standards.
- Demonstrated proficiency in product/process/system validations, design control, and risk analysis/assessments.
Preferred certifications: Six Sigma Black Belt, Lean Enterprise, Design for Six Sigma.
Important information: This position is recruited by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.
Why Kelly® The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG®) is one focus within the full array of Kelly Services® workforce solutions.
Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.
The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.
As a Kelly Services employee, you will have access to numerous perks, including:
- Vacation and sick pay
- Paid holidays
- 401(k) plan
- Group medical, vision, dental, life, and short-term disability insurance options
- Kelly Discounts on goods and services, auto and home insurance, and tuition at Kelly partner schools
- Kelly Learning Center offers free courses and trainings
- Weekly pay
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.
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?
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 is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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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