Quality Engineer
Company: LeMaitre Vascular
Location: Burlington
Posted on: May 29, 2023
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Job Description:
Uphold and improve the product quality of medical devices
manufactured and uphold regulatory requirements.
Execute day-to-day activities based on quality objectives (goals)
complementary to corporate policies and goals of building high
quality medical devices
Evaluate medical device failures (product complaints) and write
summary reports
Determine root cause and implement corrective and preventative
actions
Complete a root cause analysis of the medical device or quality
system failure
Audit the process to determine the root cause of failure
Summarize the root cause investigation for the CAPA
Develop a plan and timeline for the CAPA
Update standard operating procedures and work instructions to
reflect the changes identified in the plan
Read and interpret standards in mechanical product, packaging and
labeling for developing and updating standard operating procedures,
and reviewing or creating protocols/reports
Evaluate risk in product and packaging design and the manufacturing
process of medical devices
Audit the manufacturing process to confirm compliance to procedures
used to manufacture medical devices for assembly, packaging,
chemistry formulation of solutions, inspections and testing of the
medical devices.
Update the quality system based on non-conformities found during
internal and external audits.
Review non-conforming material reports for plan and
disposition.
Analyze and report quality system data to the quality and
manufacturing teams
Evaluate supplier performance based on data collected at incoming
inspection
Bachelor's degree or foreign equivalent in in Mechanical
Engineering, Biomedical Engineering, or closely related and 2 years
as a Quality or Validation Engineer or similar title, performing
Quality Engineering at a Medical Device or Life Science company,
including:
1 year performing corrective and preventative action activities
1 year performing risk management activities
1 year in writing non-conforming material reports
1 year collecting and analyzing quality system metrics
In order to provide equal employment and advancement opportunities
to all individuals, employment decisions at LeMaitre Vascular will
be based on merit, qualifications, and abilities. LeMaitre Vascular
does not discriminate in employment opportunities or practices on
the basis of race, color, religion, sex, national origin, age,
disability, sexual orientation, gender identity, breastfeeding or
related medical conditions, religious dress, military or veteran
status or any other characteristic protected by law.
This policy governs all aspects of employment, including selection,
job assignment, compensation, discipline, termination, and access
to benefits and training.
ID: 2023-1980
FLSA Status: Exempt (Salary)
External Company URL: lemaitre.com
Street: 32 Third Avenue
Post End Date: 6/12/2023
Keywords: LeMaitre Vascular, New England , Quality Engineer, Engineering , Burlington, Northeast
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