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

Position Summary:

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

professional interests.

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 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.