Sr. Quality Engineer
Posted on: March 14, 2023
BASIC FUNCTIONS:The role of the Senior Quality Engineer is to
work with engineering, process, and manufacturing personnel to
develop specifications, processes and procedures that will ensure
our products meet or exceed our customers' expectations. Organizer
all major components of the QMS including change control, process
control, calibration and CAPA through feedback. Continuous
improvement should be an output from the constant QMS PDCA feedback
loop. Leads the Quality Inspectors in daily activities to support
- Responsible for supervision of QA Inspectors / Technicians
(in-process and outgoing quality). This includes the review of
- Quality Assurance Inspectors:
- Performs inspections and tests for incoming, in-process, and
finished products. Serves as authority for release of Class II
Devices for further distribution. Performs complaint investigations
and service on returned products. Maintains records, including
files of device history records.
- Administrates internal audit and vendor approval.
- Assist with the coordination of activities relative to
corrective and preventive action.
- Assist in maintaining QA files of quality records - document
- Performs routine audits of the preventive maintenance program
and other internal audits as assigned.
- Responsible for assisting in the coordination and
administration of Engineering Change Orders from engineering to
manufacturing for both new products and changes to existing
- Assist in ensuring that all activities relative to the
engineering change are performed, documented, and records
maintained - regulatory requirements, process capability/control,
quality plans, etc.
- Performs trend analysis for complaints and other quality
indicators, including quality objectives.
- Responsible for the calibration program
- Set up proper instrumentation to measure and record variables
and train employees on proper use of the instruments.
- Establish Process Control Plans
- Interface with product development, manufacturing, process, and
quality personnel as well as with Span America sales and marketing
to determine product quality specifications.
- Provide all necessary information concerning product parameters
and inspection to production personnel
- Evaluate processes and ensure they are capable of consistently
meeting specification requirements
- Define attributes and sets accept/reject parameters
- Assist in developing effective corrective actions to quality
- Assist with returned product investigations as needed to
understand failure modes and actions required.
- Assist with handling customer complaints and service
- Assist with various Regulatory Activities:
- Develop regulatory strategies for product development and
launch of new products.
- Ensure that US and other international regulatory requirements
are incorporated as part of the development process.
- Assist or lead the preparation and maintenance of
moderate-complexity regulatory submissions while maintaining
- Prepare responses to standard questions and comments from
regulatory agencies and ensure issues are addressed in a timely
- Understand regulatory processes, guidelines and guidance
documents and what they mean to the organization and ensures that
they are communicated through regulatory procedures.
- Maintain facility and product registrations and licenses with
various regulatory bodies.
- Establish and maintain Technical Files as applicable.
- Compile and maintain regulatory documentation databases or
- Establish an effective Statistical Process Control
- Willing to travel to customers to resolve quality problems and
build effective customer relationships
- Hands on, action oriented, and pays attention to
- Customer/client focused
- Other duties as necessary
System Management and/or Maintenance & Development:
- Ability to understand and utilize basic statistical
- Ability to perform root cause analysis and corrective
- Ability to understand and utilize fundamental gauge validation
- Demonstrate knowledge of product fitness for use that meet or
exceed customer expectations.
- Demonstrates thorough understanding of auditing
- Ability to work independently.
- Demonstrates basic mechanical aptitude ability.
- Ability to collect, organize, analyze and report information in
a meaningful way.
Quality Management Systems:
- Ability to develop and maintain processes that are ISO, MDSAP
and FDA compliant.
- Demonstrates ability to lead and manage projects.
- Ability to train and develop internal auditors.
- Ability to utilize failure mode and effects analysis.
- Ability to identify, execute and measure improvement
- Demonstrates ability to understand and actively participate in
all company safety policies and procedures.
- Ability to develop, deliver and measure training as
PHYSICAL JOB REQUIREMENTS:
General physical demands described here are representative of those
that may be required to successfully perform the essential
functions of the job.
Individuals may sit or stand as needed. Position may require
walking and/or climbing stairs periodically throughout the day,
reaching above shoulder heights; below the waist, or lifting as
required to file documents or store materials throughout the
workday. May include lifting up to 25 pounds for files, boxes, etc.
on occasion. Proper lifting techniques are required.
Primary environment: ambient room temperatures, lighting and
traditional office equipment as found in a typical office
environment. The performance of this position may occasionally
require exposure to the manufacturing areas where the use of
personal protective equipment such as safety glasses with side
shields and fully enclosed shoes (no open toe or heel) are
- Bachelor's degree in an engineering, health science or related
- 1+ years' experience as a Quality Engineer in the medical
- If degree is not in Engineering or a Health Science field, 5+
years of Quality Engineer or Medical Device Regulatory experience
Span-America, a division of Savaria, is an EO/AA Employer of
Keywords: Span-America, Greenville , Sr. Quality Engineer, Engineering , Greenville, South Carolina
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