Kelly Services Quality Engineer in Plymouth, Minnesota
Kelly Services is currently hiring a Quality Engineer with CAPA experience to work for one of our top Medical Device customers in Plymouth, MN
The Quality Engineer will be responsible for evaluating and monitoring the development and implementation of process changes intended to correct or improve validation results
Essential Job Duties and Responsibilities:
Assists in investigating and troubleshooting validation problems for equipment and/or performance processes.
Support open CAPA’s – work to meet CAPA timelines and actions
Support product complaint investigations and escalations
Assists in writing documentation for new and current validation procedures and technical reports
Participates on teams responsible for planning and implementing corrective actions.
Perform Research and Development (R&D) activities such as define and validate product specifications, conduct experiments, data analysis
Conduct Root Cause Analysis and investigations
Experience with creating CAPA investigations, action plans, and effective monitoring plans
Coordinate the development and processing of test samples
Support project teams and project managers
Project management work related to CAPAs and other quality investigations
Write verification and validation documentation and conduct required testing as needed
Perform testing and inspection functions including forensics and root cause analysis
Assist regulatory compliance efforts and verification and documentation related to engineering standards
Author, revise, train, and provide support for production work instructions, test plans, test protocols, and test reports.
Identify new processing needs and perform continuous improvement to support sustaining efforts
Lead and facilitate process improvement activities
Role may include some project and team management responsibilities
Other responsibilities may be assigned & not all responsibilities listed may be assigned
Education, Skills, & Experience Needed to Perform Position Function:
Bachelor degree in Biomedical, Chemical, Mechanical, Electrical Engineering or equivalent
Minimum of 1 to 3 years increasingly responsible Quality or CAPA engineering experience
Prior experience in the medical device industry is preferred
Proficient in Microsoft Office
Strong technical writing skills required – proficient in Good Documentation Practices (GDP)
Strong statistical skills and knowledge of statistical software
Experience with DOE, FMEA, GMP, and QSR
SolidWorks knowledge preferred
Ability to work within an ISO structured quality system
Knowledge of engineered materials and fabrication methods
Good planning, multi-tasking, and project management skills
Demonstrated track record of completing projects on time and accomplishing goals
Ability to function independently as well as part of a team
Excellent written and oral communication skills
Ability to manage multiple priorities in fast-paced environment
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Must be legally permitted to work in the United States.
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.