Quality Engineer III - Medical Device Manufacturing
Company: Kelly Services
Location: San Angelo
Posted on: May 10, 2019
Kelly Services-- has been providing outstanding employment
opportunities to the most talented individuals in the marketplace.
We are proud to offer a temporary opportunity to work as a Sr.
Quality Engineer - Medical Device at a prestigious Fortune 500--
company working in San Angelo, TX.
This is a 10-month temporary position at 40 hours per week.
Important information: This position is recruited for by a remote
Kelly office, not your local Kelly branch. To be considered for
this position, you must use the "submit now" button below to submit
your resumes. If you have questions about the position, you may
contact the recruiter recruiting for this position
(email@example.com) however your resume must be received
via the "submit now" button included within.
- The Staff Quality Engineer will help to lead project teams and
provide major input in the development and manufacture of new
products as well the maintenance of current products, materials and
- This individual will function as a quality representative on
multi-functional product development teams in matters relating to
- Will support design control and process validation activities
for new and change product efforts.
- This individual will ensure effective and efficient use of
Quality Engineering techniques such as risk analysis, test method
development, statistical data analysis, and the development of
- This individual will lead and ensure the development of
comprehensive risk management plans and operating procedures for
the product and process.
- The Quality Engineer will ensure effective and comprehensive
- Will assist in thorough investigation of quality issues and
oversee implementation of effective corrective and/or preventive
- This individual will ensure the development and validation of
appropriate test methods for design and manufacture of products and
- The Quality Engineer will track/trend quality issues over time
and generate reports to management and across sites.
- This Quality Engineer will lead project teams, suppliers and
other disciplines to ensure compliance with company policies and
procedures as well as medical device regulations. Will assess,
implement and monitor process capability for continuous
- This Quality Engineer may be responsible for leading
cross-functional work teams and/or managing QA technicians to
include direct daily supervision, performance appraisal, behavioral
discipline, professional development and on the job training.
- The Staff Quality Engineer will serve as subject matter expert
for key technologies and quality systems.
Provide technical expertise to ensure conformance to ISO, FDA Food
Drug Administration MDD Medical Devices Directive based quality
systems. Provide support to process excellence initiatives
including Six-sigma lean thinking. Direct development consistent
application of quality policies procedures in product design
development, secondary development transfer operations. Comply with
all applicable quality management system, environmental, safety and
occupational health policies. for example, ISO 13485, ISO14001
EDUCATION and/or EXPERIENCE:
A minimum of a Bachelor s degree in Engineering, Life Science,
Physical Science or a related field is required; an advanced degree
is an asset. A minimum of 8 years Quality Engineering work
experience is preferred, with experience in the medical device,
pharmaceutical or other highly regulated industry also
Knowledge of ISO and/or cGMP regulations is preferred. New product
development experience is preferred. Supplier Quality Engineering
experience is an asset. Sterilization process experience is an
asset. General knowledge in Quality Systems Regulations QSR is an
asset. An ASQ certification CQE, CQM, CRE or CQA is an asset. Six
Sigma Green Belt, Black Belt, etc. or Process Excellence
certification is an asset. Basic knowledge in Statistics, Sampling
Planning, Risk Assessment and Process Validation is preferred.
Candidate must be able to communicate effectively at all levels
within Quality as well as cross functionally with departments such
as R D, Operations, Purchasing, Marketing and Medical Affairs. Good
communication and presentation skills will be needed. Maturity and
ability to display a high level of professionalism is required.
This position may require up to 10% travel. The ability to work
some nights/ weekends/ holidays.
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
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
is The Law.
Keywords: Kelly Services, San Angelo , Quality Engineer III - Medical Device Manufacturing, Healthcare , San Angelo, Texas
Didn't find what you're looking for? Search again!