Kelly Services Design Quality Engineer in West Palm Beach, Florida
Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have a Design Quality Engineer position available with the worlds largest, most innovative and comprehensive, orthopedic medical device design and manufacturing business located in West Palm Beach, FL.
The Senior Design Quality Engineer will be supporting the Product Development Group for the Power Tools business. The qualified candidate for this hands-on position should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility.
POSITION DUTIES & RESPONSIBILITIES:
Product development team member focused on product development and life cycle management activities related to the medical device and Power Tools business.
Lead design and development planning activities for new and sustaining projects.
Conduct formal technical design reviews throughout the phases of the product development process.
Support and approve design verification/validation activities including mechanical testing, tolerance analyses, design rationales, and surgeon based anatomical labs.
Apply basic and advanced statistical methods and design excellence tools to design verification and validation activities (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power and sample size determinations, etc.).
Support risk management activities including planning, design & clinical risk management, production risk management, and overall risk summary reporting.
Lead the cascade of critical to quality design features to product quality plans and downstream manufacturing & quality processes. Support transfer to manufacturing activities both in product development and base businesses.
Provide leadership in all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support functions.
Provide leadership in the understanding of medical device regulations to other disciplines.
Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Product Development, Regulatory, Manufacturing, and Marketing.
Work closely with suppliers on the qualification of new/changed parts and processes supporting product development. This person will conduct assessments of new suppliers as part of the project teams.
Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
EDUCATION & EXPERIENCE REQUIREMENTS:
Previous experience with medical device, product development and design/quality controls.
A minimum of a bachelor’s Degree in engineering and/or in a Technical Science is required. A Master’s degree is a plus.
A minimum of 3-4 years related industry hands on working experience in a GMP and/or ISO regulated industry is required.
Strong working knowledge of QSR (21 CFR 820) and ISO (13485, 14971) quality requirements.
Blueprint literacy including GD&T.
Knowledge of process and design excellence tools. Certification is a plus.
Candidate should possess excellent problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations.
Candidate should have a proven track record implementing Quality System improvements to meet compliance and overall business goals. Proficiency with the Microsoft Office Suite is required.
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch.
“Not open to remote workers” AND “Must be able to work in the United States without sponsorship “
As a Kelly Services employee, you will have access to numerous perks, including:
Exposure to a variety of career opportunities as a result of our expansive network of client companies
Career guides, information and tools to help you successfully position yourself throughout every stage of your career
Access to more than 3,000 online training courses through our Kelly Learning Center
Weekly pay and service bonus plans
Group-rate insurance options available immediately upon hire*
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
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter .
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.