Engineering Jobs in Loami, IL

7 positions found

ThinkBIG Internship - Fall 2026 Springfield
✦ New
Salary not disclosed
Springfield, IL 1 day ago


ThinkBIG Internship - Fall 2026 Springfield

Req No.

2025-5348

Category

ThinkBIG Internship

Location

US-IL-Springfield

Type

Regular Part-Time

Union or Non-Union

Non-Union

Division

Heavy

Company

Altorfer Inc

Working Hours/Days

8:00 am - 4:30 pm Monday - Friday

Overview

Think Big Program

(Caterpillar Dealer Service Technology Program)

If you or anyone you know is considering careers please advise them of this fantastic opportunity in a high-demand field. Students can receive their Associate in Applied Sciences while going through our paid internship! Additionally, we also have a tuition reimbursement Program for students!



Basic Duties

The Caterpillar Dealer Service Technology Program is a great opportunity for anyone interested in going to school to learn a skilled trade in a high-demand industry. Students will go through a two-year curriculum where they will rotationally attend Illinois Central College, located in East Peoria, for 8 weeks and then attend an Altorfer branch to complete an 8 week internship. This rotation continues throughout the duration of the program. A few of the courses they will take are Fundamentals of Hydraulics, Caterpillar Engine Fuel Systems, Fundamentals of Electrical Systems, Diagnostic Testing, and Undercarriage/Final Drives.



Qualifications

Please visit the link below to apply and for more information.

academics/catalog/agricultural-and-industrial-technologies/caterpillar-dealer-service-technology/

Compensation & What We Can Offer You:

  • Payrate: $18.50 per hour
  • Tuition Reimbursement
  • Tool Insurance and Safety Equipment Reimbursement
  • 401(k)
  • Paid Time Off (PTO) earn up to 40 hours of PTO per calendar year


Posted Min

USD $18.50/Hr.

Posted Max

USD $18.50/Hr.

Physical Requirements/Working Conditions

This position works in a warehouse/shop environment. May on a continuous basis walk, climb on and off equipment, bend and lift up to 75-100lbs. May be required to wear appropriate safety equipment (IE- Safety glasses or side shields) when needed. The noise level in the work environment is usually moderate to high. May intermittently sit at a desk for a period of time to answer telephone and write or use a keyboard to communicate through email. Must be flexible to work varying schedules and hours as needed. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Why Work for Altorfer?

At Altorfer, our iron is just the beginning. Our people make our company successful, and we would not be who we are without them. As a third generation, family-owned company created in 1957, we bring our values into how we do business. Everyone from technicians, sales representatives, administrative professionals, or somewhere in between is part of the "A-Team" and is critical to our success. Here at Altorfer, we have over 35 locations and 1300 employees with long tenure for you to learn from. We have a collaborative, family valued culture, with a great reputation in the industry. A company that offers competitive pay, excellent benefits, and a remarkable team of people to work with.



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internship
Engineer Supplier Quality
Salary not disclosed
Auburn 1 week ago
Job Summary Support Medline’s Supplier Quality operations by executing supplier qualification, monitoring, and performance activities for a global supply base.

This role assists with supplier assessments, documentation review, audits, and issue resolution to ensure compliance with FDA regulations, ISO standards, and internal quality system requirements.

The position partners cross functionally while developing foundational expertise in supplier quality and regulatory compliance.

Job Description MAJOR RESPONSIBILITIES Conduct supplier audits to verify compliance with ISO 9001, ISO 13485, and applicable regulatory requirements related to high-risk vendors.

Support supplier qualification, re‑qualification, and disqualification activities for moderate to high‑risk suppliers, including documentation review and approval routing.

Review and approve supplier quality records and compliance documentation in accordance with internal procedures.

Execute Supplier Corrective Action Requests (SCARs) by tracking actions, verifying evidence, and documenting effectiveness under supervision.

Assist with supplier communication related to quality requirements, documentation requests, and corrective actions to Medline’s internal business partners and external suppliers Provide technical guidance and training to suppliers on quality standards and best practices.

Support containment activities and investigations related to supplier nonconformances Utilize root cause analysis and risk management tools to prevent recurrence of issues.

Maintain accurate and timely records of supplier audits, performance reviews, nonconformances, and corrective actions.

Prepare routine reports, dashboards, and summaries for supplier quality performance and compliance tracking.

MINIMUM JOB REQUIREMENTS Education Bachelor’s degree in Engineering, Biology, Quality Management, or related field.

Certification / Licensure Work Experience 3–5 years in supplier quality, manufacturing quality, or similar role.

Knowledge / Skills / Abilities Knowledge of ISO standards, FDA regulations (if applicable), statistical process control (SPC), and quality tools (FMEA, PPAP, APQP).

Strong communication, problem-solving, and negotiation skills.

Medical Device or drug experience Travel up to 25% (domestic and/or international) PREFERRED JOB REQUIREMENTS Education Certification / Licensure ASQ Certified Quality Engineer (CQE) or Certified Supplier Quality Professional.

Six Sigma Green Belt or higher.

Work Experience Supplier quality auditing Audit hosting experience Knowledge / Skills / Abilities DISCLAIMER All duties and requirements are subject to possible modification to reasonably accommodate individuals with disabilities.

This position description in no way states or implies that these are the only duties to be performed by an employee occupying this position.

Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor(s)/manager(s).

This document does not create an employment contract, implied or otherwise, other than an "at will" employment relationship.

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: $92,000.00
- $138,000.00 Annual 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 page here .

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.
Not Specified
Nuclear Engineer
Salary not disclosed
Chatham, Illinois 1 week ago

Job Title : Nuclear Engineer (Naval Reactors Engineer) Category / Component : Officer • Active Overview Design, regulate, and oversee the Navy's nuclear propulsion program, including reactor design, fleet operations, and eventual defueling and decommissioning of nuclear powered ships and submarines from Naval Reactors Headquarters and associated Department of Energy laboratories and shipyards.

Key Responsibilities Provide technical direction in areas such as reactor and fluid systems design, reactor physics, materials development, component design for steam generators, pumps, and valves, instrumentation and control for reactor and propulsion plants, testing and quality control, radiation shielding, and chemistry and radiological controls; review designs and analyses from laboratories, shipyards, and industry partners; coordinate with fleet units to ensure safe and reliable nuclear plant operation.

What to Expect Assume significant technical responsibility early in your career as part of a lean headquarters staff; work primarily in an analytical and oversight role rather than operating plants at sea; balance long term engineering projects with time sensitive fleet and shipyard issues; frequent coordination with senior civilian engineers, naval officers, and technical teams; high expectations for attention to detail, judgment, and written and oral communication.

Work Environment Work mainly at Naval Reactors Headquarters in the Washington, District of Columbia area with regular engagement with Department of Energy laboratories, nuclear training sites, shipyards, and nuclear powered ships and submarines; office based work that includes document reviews, technical meetings, inspections, and site visits rather than day to day shipboard watchstanding.

Pathways, Training & Advancement Officer commissioning through programs such as Officer Candidate School or the Nuclear Propulsion Officer Candidate program followed by a structured technical qualification program at Naval Reactors; rotational exposure to laboratories, prototypes, shipyards, and fleet support issues; progressive responsibility leading projects and becoming a subject matter expert, with opportunities for professional military education and advanced graduate study in technical fields.

Entry through the Nuclear Propulsion Officer Candidate program for qualified college students and recent graduates, or selection via Officer Candidate School for those who already hold qualifying degrees; all applicants must meet Nuclear Propulsion Program academic and technical screening standards in addition to general officer commissioning requirements.

Qualifications All Navy jobs require meeting general enlistment or commissioning standards, which typically include: Eligibility to serve in the United States Navy, which may involve United States citizenship or other legal residency and work status, depending on the program and current law and policy A high school diploma or equivalent for enlisted positions, and a bachelor's or qualifying professional degree for officer positions Meeting age limits that vary by program and are set in law and Navy policy.

Some communities have more restrictive age ranges Meeting medical, vision, and dental standards, including body composition and physical fitness requirements, with some jobs requiring more demanding standards Meeting character and conduct standards, including background screening Achieving required test scores for your program, such as the Armed Services Vocational Aptitude Battery for enlisted roles or officer qualification tests for officer programs Eligibility for a security clearance when required for your rating or designator Additional qualifications can include specific skills, education, licensure, or experience that are unique to a job or community and will be reviewed with you by a recruiter.

Additional qualifications for this job may include: Completion of a rigorous technical degree in engineering, physics, mathematics, or a closely related field that includes strong backgrounds in calculus and physics; outstanding academic record, particularly in technical coursework; United States citizenship and eligibility for a high level security clearance; strong technical aptitude and comfort with detailed analytical work.

Education Education benefits are available through standard Navy programs such as Tuition Assistance, the Post-9/11 GI Bill, ACE-recommended college credit for Navy training, Navy COOL-funded certifications, USMAP apprenticeships, and other Navy College Program opportunities.

Specific options depend on the Sailor's status, training, and current Navy policy.

Pay, Benefits & Service Pay, benefits, and service commitments follow standard Navy Active and/or Reserve policies for this type of role, including basic pay, allowances when eligible, health coverage, and retirement options.

Exact entitlements, special pays, and service obligations depend on program, component, years of service, and current law and Navy guidance.

Incentives Incentives such as bonuses, special pays, and loan repayment may be available at times for specific ratings or communities, but they change frequently and cannot be guaranteed.

Applicants must confirm current incentives and eligibility with an official Navy recruiter or authoritative Navy source.

Notes and Disclaimers This description is a general overview of typical duties, training, and opportunities in this community.

It does not replace official Navy instructions, policies, or contracts and does not guarantee specific assignments, training, incentives, or outcomes.

Actual opportunities depend on Navy needs, individual performance, screening results, and current law and policy.

Not Specified
Sr Engineer Supplier Quality
🏢 Medline Industries - Transportation & Operations
Salary not disclosed
Auburn 1 week ago
Job Summary The Sr Engineer Supplier Quality will lead Medline’s supplier quality oversight for a global supply base.

They will own risk‑based qualification, performance management, scorecards, and audit execution for high‑risk suppliers; act as SME on purchasing controls (21 CFR 820 §820.50 and ISO 13485:2016 7.4) and represent Supplier Quality during internal/external inspections.

The Sr Engineer drives cross‑functional corrective and preventive actions and supplier development to improve quality, reliability, and compliance.

Job Description MAJOR RESPONSIBILITIES Lead risk‑based supplier oversight across regions; set audit/monitoring depth by risk tier and product classification Lead communication efforts related to high-risk suppliers with internal stakeholders Own complex supplier qualifications and disqualifications for critical suppliers, including technical documentation reviews and potential on‑site assessments Author and maintain supplier quality agreements and inspection plans with Procurement/Legal; ensure alignment with device regulations and regional requirements Own the supplier scorecard program for assigned categories; analyze trends and drive SCAR/CAPA to effectiveness verification; escalate per governance Work with quality support groups (ex.

Risk Management, Design and Development, Post-Market Surveillance, etc) to proactively identify issues and lead the containment of them Lead partnership with procurement, engineering, and operations teams to resolve supplier-related quality issues Provide technical guidance and training to suppliers on quality standards and best practices Troubleshoot in-depth vendor issues that impact multiple business units to improve the global supply chain and improve supplier processes Mentor Quality Engineers/QEDP associates and coach divisional QA on supplier controls, SCAR quality, and problem‑solving methods Maintain accurate records of audits, performance reviews, and compliance reports Oversees scorecard program and executive quality metric dashboards Assist or perform audits associated with high-risk suppliers to ISO 13485, ISO 9001, and/or and applicable regulatory requirements MINIMUM JOB REQUIREMENTS Education Bachelor’s degree in Engineering, Biology, Quality Management, or related field Certification / Licensure Work Experience 6-8 years in supplier quality, manufacturing quality, or similar role Knowledge / Skills / Abilities In-depth knowledge of ISO standards and FDA regulations Strong communication, problem-solving, and negotiation skills Ownership of CAPA or SCAR throughout it’s lifecycle Strong Medical Device or Drug regulatory experience Strong critical thinking abilities Experience with statistical process control (SPC), and quality tools (FMEA, PPAP, APQP) Travel up to 25% (domestic and/or international) PREFERRED JOB REQUIREMENTS Education Masters of Biology, Chemistry, Engineering, Quality Management, or similar field Certification / Licensure ASQ Certified Quality Engineer (CQE) or Certified Supplier Quality Professional Six Sigma Green Belt or higher Work Experience Front or backroom FDA or ISO audit experience Supplier quality auditing 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: $116,000.00
- $174,000.00 Annual 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 page here .

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.
Not Specified
Project Manager QC
🏢 Medline Industries - Transportation & Operations
Salary not disclosed
Auburn 2 weeks ago
Job Summary The position will guide the development of medical devices, dietary supplements, cosmetics, and/or OTC/ANDA/NDA drugs.

Manage and oversee all aspects of product development projects.

This position will be responsible for leading collaborative, multifunctional teams consisting of R&D personnel, quality, regulatory, manufacturing, and product divisions.

Job Description MAJOR RESPONSIBILITIES Manage assigned projects, balance corporate priorities, and ensure team alignment across functional areas to ensure that project deadlines and goals are met.

Manage the product development process utilizing an iterative agile project management framework.

Independently oversee a portfolio of projects and ensure that project and divisional goals are aligned.

Develop, communicate, and track project plans, objectives, budgets, scope, timelines, and projected end dates.

Translate project goals into project tasks.

Conduct risk assessments to identify issues that may cause project delays or cost overruns and develop contingency plans to mitigate the impact.

Compile risk profiles associated with scope creep and changing project requirements.

Maintain team morale and engagement by ensuring constant and transparent communication.

Compile technical justifications and data summaries in support of product claims.

Lead process improvement initiatives.

Represent Medline on various ASTM/AAM/ISO technical committees and contribute to the development of new test standards.

MINIMUM JOB REQUIREMENTS Education Bachelor's degree in Engineering or Science related field.

Work Experience At least 2 years of experience in a medical device or pharmaceutical related field.

Knowledge / Skills / Abilities Project management Microsoft Project.

Knowledge of medical device requirements (Class I-II), design controls, risk assessments, and the 510k process.

Position may require travel up to 10% of the time for business purposes (domestic and international).

Position may require travel up to 50% of the time for business purposes (domestic only).

PREFERRED JOB REQUIREMENTS Licensure/Certification PMP Certification.

Experience in the development and launch of new medical/pharma products.

DISCLAIMER All duties and requirements are subject to possible modification to reasonably accommodate individuals with disabilities.

This position description in no way states or implies that these are the only duties to be performed by an employee occupying this position.

Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor(s)/manager(s).

This document does not create an employment contract, implied or otherwise, other than an "at will" employment relationship 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: $92,000.00
- $138,000.00 Annual 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 page here .

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.
Not Specified
Sr Quality Assurance Auditor - Chicagoland area
🏢 Medline Industries - Transportation & Operations
Salary not disclosed
Auburn 2 weeks ago
Job Summary Only considering candidates local to the Chicagoland area or willing to relocate at this time.

JOB SUMMARY: Audit a broad, global supplier base against FDA regulations, ISO standards, and other applicable global regulatory requirements across the full spectrum of Medline products including sterile products, APIs, raw materials, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements, as well as contract sterilizers and laboratories.

Perform internal audits of Medline divisions and manufacturing sites.

Lead complex, critical, supplier regulatory projects involving cross-functional teams.

Job Description MAJOR RESPONSIBILITIES: Act as senior team leader to support Supplier QA Management and facilitate strategic achievement of Supplier Quality goals.

As a Subject Matter Expert, provide training and consulting services to internal departments to understand and comply with Quality Management System requirements.

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.

Evaluate Medline suppliers to determine approval status.

Assist in development of Regulatory/Quality Management Systems for potential suppliers.

Plan, schedule and execute complex internal audits in accordance with applicable FDA regulations, ISO standards, and other global regulatory requirements.

Conduct adequate CAPA follow-up for supplier and internal audits.

Write audit reports and communicate results to upper management.

Plan and coordinate all travel for both supplier and internal audits, both domestically and internationally.

Assist in the review and writing of responses to observations issued by FDA or other regulatory agencies.

Aid in preparation for FDA inspections and/or audits by other regulatory agencies for both Medline facilities and suppliers.

Manage and participate in quality initiatives to maintain and improve compliance, such as evaluate internal processes, suggest and implement improvements, and create and revise applicable procedures and SOPs.

Assess compliance risk of systems, facilities, and procedures per applicable regulations through audits and assessments, assuring compliance to regulatory requirements and Medline specifications, including novel and high-risk products and services.

Assist in integration of new acquisitions into Medline’s quality system.

Perform due diligence audits for potential acquisitions.

Provide mentoring, coaching, and training to junior auditors, divisional QA team members, and divisional QA Managers.

Assist in managing the rotational QA program.

Education
- Bachelor’s degree in microbiology, chemistry, engineering or related field.

Work Experience
- At least 4 years of experience auditing FDA regulated medical Device or pharmaceuticals OR at least 5 years working in senior level quality role within medical device or pharmaceutical manufacturing.

- Experience with FDA regulations (21 CFR 820, 21 CFR 210/211).

- Experience with ISO 13485.

- Experience applying knowledge of process validation, method validation and sterilization processes.

Knowledge / Skills / Abilities
- Detail-oriented, with excellent oral and written communication skills.

- Ability to listen and process all relevant details, understanding and prioritizing their importance and drawing clear and concise conclusions.

- Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives and determining when escalation of issues is necessary.

- Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines.

- Position requires travel up to 50% of the time for business purposes (within state, out of state and/or internationally).

PREFERRED JOB REQUIREMENTS
- Experience with USP 61/62 for Microbial Testing of Non-Steriles.

- Experience applying knowledge of process validation, method validation and sterilization processes.

- Experience in CAPA (Corrective and Preventive Actions) management.

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: $92,000.00
- $138,000.00 Annual 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 page here .

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.
Not Specified
Sr Auditor QA (Sterilization)
🏢 Medline Industries - Transportation & Operations
Salary not disclosed
Auburn 2 weeks ago
Job Summary JOB SUMMARY: Audit a broad, global supplier base against FDA regulations, ISO standards, and other applicable global regulatory requirements across the full spectrum of Medline products including sterile products, APIs, raw materials, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements, as well as contract sterilizers and laboratories.

Perform internal audits of Medline divisions and manufacturing sites.

Lead complex, critical, supplier regulatory projects involving cross-functional teams.

Job Description
**Position requires travel of up to 50% of the time for business purposes (within state, out of state and/or internationally)
** Although Remote, the selected individual will be required to visit the office (Chicagolandarea).

This role is primarily responsible for auditing sterilization processes to ensure compliance with regulatory standards and internal quality requirements MAJOR RESPONSIBILITIES:
- Act as senior team leader to support Supplier QA Management and facilitate strategic achievement of Supplier Quality goals.

- As a Subject Matter Expert, provide training and consulting services to internal departments to understand and comply with Quality Management System requirements.

- 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.

- Evaluate Medline suppliers to determine approval status.

Assist in development of Regulatory/Quality Management Systems for potential suppliers.

- Plan, schedule and execute complex internal audits in accordance with applicable FDA regulations, ISO standards, and other global regulatory requirements.

- Conduct adequate CAPA follow-up for supplier and internal audits.

- Write audit reports and communicate results to upper management.

- Plan and coordinate all travel for both supplier and internal audits, both domestically and internationally.

- Assist in the review and writing of responses to observations issued by FDA or other regulatory agencies.

- Aid in preparation for FDA inspections and/or audits by other regulatory agencies for both Medline facilities and suppliers.

- Manage and participate in quality initiatives to maintain and improve compliance, such as evaluate internal processes, suggest and implement improvements, and create and revise applicable procedures and SOPs.

- Assess compliance risk of systems, facilities, and procedures per applicable regulations through audits and assessments, assuring compliance to regulatory requirements and Medline specifications, including novel and high-risk products and services.

- Assist in integration of new acquisitions into Medline’s quality system.

Perform due diligence audits for potential acquisitions.

- Provide mentoring, coaching, and training to junior auditors, divisional QA team members, and divisional QA Managers.

Assist in managing the rotational QA program.

Education
- Bachelor’s degree in microbiology, chemistry, engineering or related field.

Work Experience Key requirements in a nutshell: Sterilization validations, re-validation.

One or a combination of radiation (gamma/e-beam), EO (Ethylene Oxide), or Steam.

Test method validations (bioburden and sterility).

Along with:
- At least 4 years of experience auditing FDA regulated medical Device or pharmaceuticals OR at least 5 years working in senior level quality role within medical device or pharmaceutical manufacturing.

- Experience with FDA regulations (21 CFR 820, 21 CFR 210/211).

- Experience with ISO 13485.

- Experience applying knowledge of process validation, method validation and sterilization processes.

Knowledge / Skills / Abilities
- Detail-oriented, with excellent oral and written communication skills.

- Ability to listen and process all relevant details, understanding and prioritizing their importance and drawing clear and concise conclusions.

- Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives and determining when escalation of issues is necessary.

- Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines.

- Position requires travel up to 50% of the time for business purposes (within state, out of state and/or internationally).

PREFERRED JOB REQUIREMENTS
- Experience with USP 61/62 for Microbial Testing of Non-Steriles.

- Experience applying knowledge of process validation, method validation and sterilization processes.

- Experience in CAPA (Corrective and Preventive Actions) management.

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: $92,000.00
- $138,000.00 Annual 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 page here .

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.
Not Specified
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