Jobster LLC
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We are a growing
patient-centric medical device company
developing the
next generation of hydraulic drug delivery systems . Our mission is to improve patient quality of life by ensuring life-saving injectable medications are available
anytime, anywhere . With a presence in virtually every country, we tackle some of the most challenging global health issues affecting patient access to treatments.
Our team is highly cross-functional and deeply passionate about innovation. Every perspective is encouraged, and initiative is expected. As a
Quality Engineer , you will be a
respected and valued member of our technology team , directly contributing to the safety, reliability, and effectiveness of products that change lives.
Position Overview The
Quality Engineer
will play a critical role in ensuring compliance with medical design controls, regulatory requirements, and product quality standards. You will be responsible for writing protocols, assisting in qualifying our
Denville laboratory , calibrating and maintaining testing equipment, monitoring qualifying events at our laboratory and manufacturing partners, and reviewing batch releases.
Responsibilities
Apply working knowledge of
medical design controls
and
regulatory requirements .
Develop and implement
quality procedures
across incoming, in-process, final inspection, and release activities.
Interpret
engineering drawings
to define gauging methods; perform
first article and dimensional inspections .
Initiate release of material to manufacturing and maintain GMP documentation.
Manage the
calibration system , perform calibrations, and execute preventive maintenance on equipment, fixtures, and gauges.
Maintain training files, calibration logs, and other GMP quality records.
Collect and analyze quality data; prepare
quality reports
and support
management reviews .
Support internal audits and other quality system requirements.
Execute and monitor lab testing as required.
Collaborate with cross-functional teams, manufacturing partners, and suppliers on quality-related issues.
Perform other duties as assigned to ensure operational excellence.
Qualifications Experience
Minimum
8 years of hands‑on inspection experience , preferably in
medical devices
or equivalent regulated industries.
Strong background in
quality systems
(ISO 9000, FDA QSR).
Experience with
system documentation
and maintaining GMP compliance.
Proficiency in
MS Excel, Word , and familiarity with statistical analysis; specialized statistical software preferred.
Solid
mathematics and statistical analysis
skills.
Certifications such as
CMI
(Certified Mechanical Inspector) or
CQT
(Certified Quality Technician) preferred.
Education
High school diploma or higher education in a relevant discipline.
Strong math skills are essential.
Physical Demands
Ability to perform light lifting (up to 20 lbs).
Ability to stand for extended periods (up to 4 hours).
Willingness to travel periodically (~5%) for supplier audits and project support.
Seniority level Mid-Senior level
Employment type Contract
Job function Quality Assurance
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We are a growing
patient-centric medical device company
developing the
next generation of hydraulic drug delivery systems . Our mission is to improve patient quality of life by ensuring life-saving injectable medications are available
anytime, anywhere . With a presence in virtually every country, we tackle some of the most challenging global health issues affecting patient access to treatments.
Our team is highly cross-functional and deeply passionate about innovation. Every perspective is encouraged, and initiative is expected. As a
Quality Engineer , you will be a
respected and valued member of our technology team , directly contributing to the safety, reliability, and effectiveness of products that change lives.
Position Overview The
Quality Engineer
will play a critical role in ensuring compliance with medical design controls, regulatory requirements, and product quality standards. You will be responsible for writing protocols, assisting in qualifying our
Denville laboratory , calibrating and maintaining testing equipment, monitoring qualifying events at our laboratory and manufacturing partners, and reviewing batch releases.
Responsibilities
Apply working knowledge of
medical design controls
and
regulatory requirements .
Develop and implement
quality procedures
across incoming, in-process, final inspection, and release activities.
Interpret
engineering drawings
to define gauging methods; perform
first article and dimensional inspections .
Initiate release of material to manufacturing and maintain GMP documentation.
Manage the
calibration system , perform calibrations, and execute preventive maintenance on equipment, fixtures, and gauges.
Maintain training files, calibration logs, and other GMP quality records.
Collect and analyze quality data; prepare
quality reports
and support
management reviews .
Support internal audits and other quality system requirements.
Execute and monitor lab testing as required.
Collaborate with cross-functional teams, manufacturing partners, and suppliers on quality-related issues.
Perform other duties as assigned to ensure operational excellence.
Qualifications Experience
Minimum
8 years of hands‑on inspection experience , preferably in
medical devices
or equivalent regulated industries.
Strong background in
quality systems
(ISO 9000, FDA QSR).
Experience with
system documentation
and maintaining GMP compliance.
Proficiency in
MS Excel, Word , and familiarity with statistical analysis; specialized statistical software preferred.
Solid
mathematics and statistical analysis
skills.
Certifications such as
CMI
(Certified Mechanical Inspector) or
CQT
(Certified Quality Technician) preferred.
Education
High school diploma or higher education in a relevant discipline.
Strong math skills are essential.
Physical Demands
Ability to perform light lifting (up to 20 lbs).
Ability to stand for extended periods (up to 4 hours).
Willingness to travel periodically (~5%) for supplier audits and project support.
Seniority level Mid-Senior level
Employment type Contract
Job function Quality Assurance
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