Assistant Quality Manager - Audit

Job Summary

Job Description

• Ensurequalityandregulatorycompliancewithapplicableregulations(ex.QSR,GMP,ISO)pertainingtotheapplicablelifecycleand regions of distribution for the product.
• Responsible for auditing and supporting appropriate product documentation (e.g. Device Master Records,Design Controls, Risk Management, and CE Technical Files) in compliance with applicable regulations. Work with Regulatory Groups and Suppliers to conduct audits as required.
• ActsasaliaisonwiththeDivisions,Suppliers,Manufacturing,and/orOperationstoensurequalityproductsandcustomer satisfaction.
• Manage supplier and internal audit schedule
• Identify,implementandmanagetheexecutionofcontinuousimprovementprojects.
• Assistthedivisioninproductevaluationfromaqualityassuranceandregulatorycompliancestandpoint.Assistintheplanningof the design, inspection, process validations, and coordinate testing to assure quality products or components.
• Plan, schedule and execute complex and high-risk supplier audits to evaluate QMS and regulatory compliance in accordance with FDA regulations, ISO13485, MDSAP, MDD/MDR and other applicable global regulatory requirements for manufacturers of a diverse finished product portfolio (including APIs, sterile products, medical devices, cosmetics, pharmaceuticals, biologics, medical foods, and dietary supplements), as well as contract sterilizers, laboratories and raw material suppliers.
• Resolveissuesrelatingtoproductorproductionqualitybyinterfacingwithinternalandexternalcustomers.
• Leadinvestigationsofproductandprocessnon-conformancesandout-of-specificationresultsandcollaboratewithsupplier representatives, as needed, to develop effective corrective and preventive actions (CAPA, SCAR).

Managementresponsibilities:

• Typicallyoverseesteamsof2-3employeesdependingontheworkloadandlevelofinvolvementneededwithdirectreports. Teams may consist of Quality Auditors
• Day-to-dayoperationsofagroupofemployees;
• Mayhavelimitedbudgetaryresponsibilityandusuallycontributestobudgetaryimpact;
• Interpretandexecutepoliciesfordepartments/projectsanddevelops;
• Recommendandimplementnewpoliciesormodificationstoexistingpolicies;
• Providegeneralguidelinesandparametersforstafffunctioning;
• Key participant in hiring staff, recommending pay increases, performing performance reviews, training and development of staff,estimatingpersonnelneeds,assigningwork,meetingcompletiondates,interpretingandensuringconsistentapplication of organizational policies.

Minimum Requirements:

• TypicallyrequiresaBachelor’sdegreeinEngineering,Science,Mathorotherrelatedtechnicalfield.

Medline 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:

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.

We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging pagehere.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.