Company: System One
Posted on: June 25, 2022
Title: Sr. Quality Engineer I Location: Elkton, MD Schedule: M-F
8-5pm Type: Direct/Permanent Compensation: -Midpoint 102,500
-*please note this is the midpoint and there is flexibility
depending on experience* Start date: Immediate This position is
responsible for providing quality engineering experience and
support to operations and product development engineering to
investigate, plan, and implementing product quality improvements in
and/or additions to current products and manufacturing processes
that directly affect safety, quality, regulatory compliance, and/or
- In all actions, demonstrates a primary commitment to patient
safety and product quality by maintaining compliance to the Quality
Policy and all other documented quality processes and
- Provide quality engineering expertise and leadership required
to plan and implement specified projects to be completed including
organizing and leading projects of various departments, planning
and scheduling, coordinating resources (personnel, materials, time,
money, suppliers), preparing proper documentation, etc.
- Lead cause-identification and problem-resolution for various
types of quality, production, or service-related issues.
- Monitor and control quality processes, identify issues and
ensure they are resolved.
- Provide guidance in the design, fabrication, development,
installation, validation, and qualification of equipment /
processes which may include feasibility studies and/or proper
documentation for justification of project and training.
- Plan and implementation of quality related projects to develop,
install, and qualify new processes for manufacturing new products
or improving existing processes.
- Plan work schedules, expenditures, attend meetings, and prepare
monthly reports as required.
- Maintain and support ESD program as required by site.
Responsibilities may include updating ESD documentation and
monitoring ongoing practices.
- Assign, delegate, and assist in the completion of engineering
tasks or projects to other engineers in the department.
- Requires a four-year college degree in an engineering,
scientific, or technical discipline with a minimum of six years of
experience in a Quality Engineering or Process Engineering role in
a regulated environment or a master's degree with a minimum of five
years of experience. In lieu of a four-year degree, a high school
diploma or equivalent, and eleven years of quality engineering
experience in a regulated manufacturing environment.
- Intermediate computer software skills, i.e. Microsoft Office.
Industry-recognized certification (e.g. CQE, CQA, PE)
- The position exists in office and manufacturing environments
within a manufacturing facility. May require gowning procedures for
controlled environment. May work in lab environment with chemicals,
electronic equipment, bovine and/or human blood, and/or
biohazardous materials that require the use of personal protective
equipment. May require the use of eye protection, hand protection,
and, depending on noise level, may require hearing protection.
Requires sitting for long periods of time with occasional stooping,
bending, reaching, grasping, etc.
- May require occasional lifting, carrying, pushing, pulling, of
objects up to, but not limited to, 40 lbs. Frequent repetitive
motion tasks performed.
- Requires travel up to 10%.This position may be eligible to work
remotely 20% of the time. This may change based on job
responsibilities, project/business needs and/or Associate job
Keywords: System One, Wilmington , Quality Engineer, Engineering , Elkton, Delaware
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