Associate Quality Specialist | Remote
JOB SUMMARYThis role specializes in one or two particular subsection(s) of our Quality Management System (e.
g.
Device Master Records, customer complaint, product hold, recalls, incoming quality, etc.
).
Responsible for basic building and maintaining quality documentation and processes such as product specifications, manufacturing tolerances, engineering drawings, inspection criteria, testing reports, ERP system analysis, customer complaint analysis and validations.
Responsible for coordinating and performing tests on product as needed.
MAJOR RESPONSIBILITIESCollaborate closely with cross functional groups (i.
e.
R&D, Engineering, product management, manufacturing, marketing, sales and quality) to build and maintain appropriate analysis and product documentation.
This can include but not limited to Device Master Records, customer complaint analysis, product hold, recalls, incoming quality, product specifications.
Ensure documentation is compliant with and is maintained to applicable FDA, ISO and internal requirements.
Review all related documentation and analysis for completeness, accuracy, and assure the product and reports meets all specifications.
Review and approve Engineering Change Orders (ECO).
Qualifications :
MINIMUM JOB REQUIREMENTSEducation High School diploma plus 1 year of experience, preferably with medical devices.
Knowledge / Skills / AbilitiesExperience in processing all relevant details, understanding and prioritizing their importance, and drawing clear and concise conclusionsExperience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.
Ability to work independently with little or no supervision to complete objectives and determining when escalation of issues is necessary.
Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook).
Position requires up to 10% travel.
PREFERRED JOB REQUIREMENTSEducation Bachelor's degreeMedline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position is $45,760 to $66,040 annually.
This salary range is an estimate and the actual salary will vary based on applicant's location, education, experience, skills, and abilities.
This role is bonus and/or incentive eligible.
Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc.
, for employees working 30 or more hours per week on average.
For a more comprehensive list of our benefits please click here.
For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
Salary:
$45,760 to $66,040 per year.
Estimated Salary: $20 to $28 per hour based on qualifications.
g.
Device Master Records, customer complaint, product hold, recalls, incoming quality, etc.
).
Responsible for basic building and maintaining quality documentation and processes such as product specifications, manufacturing tolerances, engineering drawings, inspection criteria, testing reports, ERP system analysis, customer complaint analysis and validations.
Responsible for coordinating and performing tests on product as needed.
MAJOR RESPONSIBILITIESCollaborate closely with cross functional groups (i.
e.
R&D, Engineering, product management, manufacturing, marketing, sales and quality) to build and maintain appropriate analysis and product documentation.
This can include but not limited to Device Master Records, customer complaint analysis, product hold, recalls, incoming quality, product specifications.
Ensure documentation is compliant with and is maintained to applicable FDA, ISO and internal requirements.
Review all related documentation and analysis for completeness, accuracy, and assure the product and reports meets all specifications.
Review and approve Engineering Change Orders (ECO).
Qualifications :
MINIMUM JOB REQUIREMENTSEducation High School diploma plus 1 year of experience, preferably with medical devices.
Knowledge / Skills / AbilitiesExperience in processing all relevant details, understanding and prioritizing their importance, and drawing clear and concise conclusionsExperience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.
Ability to work independently with little or no supervision to complete objectives and determining when escalation of issues is necessary.
Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook).
Position requires up to 10% travel.
PREFERRED JOB REQUIREMENTSEducation Bachelor's degreeMedline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position is $45,760 to $66,040 annually.
This salary range is an estimate and the actual salary will vary based on applicant's location, education, experience, skills, and abilities.
This role is bonus and/or incentive eligible.
Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc.
, for employees working 30 or more hours per week on average.
For a more comprehensive list of our benefits please click here.
For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
Salary:
$45,760 to $66,040 per year.
Estimated Salary: $20 to $28 per hour based on qualifications.
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