Quality Compliance

Maintenance Mechanic – Manufacturing | Packaging Equipment & SAP-PM | Chicago, IL

Maintenance Mechanic – Manufacturing

📍 Chicago, Illinois
💰 $38.77 per hour
🕒 Second or Third Shift
💼 Full-Time | Union Position
🏭 Onsite – Manufacturing/Bakery Facility
👥 Three Openings
🚫 No Visa Sponsorship
🚚 No Relocation Assistance

Position Overview

A leading manufacturing organization is seeking three experienced Maintenance Mechanics to support a high-speed production and packaging facility in Chicago.

This hands-on position is responsible for maintaining the safe, efficient, and reliable operation of processing, packaging, and facility equipment. Working with limited supervision in a team-based environment, the Maintenance Mechanic will perform preventive maintenance, troubleshoot breakdowns, complete mechanical repairs, and help minimize production downtime.

Candidates must be available to work either second or third shift.

Key Responsibilities

Preventive Maintenance and CMMS

  • Complete scheduled preventive maintenance activities across production and facility equipment.

  • Document maintenance work, work orders, repairs, and equipment improvements using SAP Plant Maintenance.

  • Maintain accurate equipment and maintenance records within the plant’s computerized maintenance management system.

  • Use condition-monitoring equipment, including thermography cameras and ultrasound tools.

  • Identify potential equipment failures before they interrupt production.

Mechanical Troubleshooting and Repair

  • Diagnose, repair, and replace defective components on high-speed processing and packaging equipment.

  • Troubleshoot pumps, hydraulics, pneumatics, mechanical drives, and foundational electrical systems.

  • Perform basic machining, welding, fabrication, and mechanical adjustment work.

  • Complete root-cause analysis for recurring equipment failures.

  • Respond quickly to live breakdown calls and restore equipment performance safely.

  • Follow the correct testing and diagnostic sequence for complex processing equipment.

Technical Documentation

  • Read and interpret:

    • Mechanical and electrical schematics

    • Piping and instrumentation diagrams

    • Blueprints

    • Block diagrams

    • Equipment drawings and sketches

  • Use technical documentation to support equipment diagnostics, repairs, and improvements.

Collaboration and Continuous Improvement

  • Work alongside engineers, electricians, boiler room personnel, production teams, and technical specialists.

  • Communicate equipment status and outstanding maintenance requirements during shift handovers.

  • Help identify and resolve recurring operational problems.

  • Support continuous improvement initiatives involving TPM, Lean, and Six Sigma methodologies.

  • Share technical knowledge and contribute to the development of other team members.

Safety and Equipment Operation

  • Follow all Lockout/Tagout, Hot Work, and Confined Space procedures.

  • Work in accordance with NEC and NFPA requirements.

  • Safely operate forklifts, man lifts, ladders, scaffolding, and other material-handling equipment.

  • Comply with GMP, HACCP, QCMS, health-code, and food-safety requirements.

Minimum Requirements

  • High school diploma or GED.

  • At least two to four years of hands-on experience as a Maintenance Mechanic within a manufacturing environment, or successful completion of an approved apprenticeship or technical training program.

  • Strong mechanical knowledge covering:

    • Pumps

    • Hydraulics

    • Pneumatics

    • Mechanical drives

    • Basic machining

    • Welding

    • Hand and power tools

    • Foundational electrical systems

  • Ability to diagnose equipment problems and perform root-cause analysis.

  • Ability to work effectively with limited supervision.

  • Strong teamwork and communication skills.

  • Willingness and ability to work second or third shift.

  • No visa sponsorship is available.

Preferred Qualifications

  • Maintenance experience involving high-speed processing or packaging lines.

  • Experience within food and beverage, pharmaceutical, chemical, or another highly regulated manufacturing environment.

  • Familiarity with SAP-PM or another computerized maintenance management system.

  • Knowledge of TPM, Lean Manufacturing, or Six Sigma principles.

  • Familiarity with AutoCAD and technical file-management software.

  • Experience training, mentoring, or sharing technical knowledge with colleagues.

  • Knowledge of condition-based monitoring methods.

Physical and Environmental Requirements

  • Ability to lift up to 50 pounds independently.

  • Ability to climb stairs and work from ladders, lifts, and scaffolding.

  • Ability to crawl over, under, or inside manufacturing equipment when completing maintenance work.

  • Ability to maintain balance while working around industrial machinery.

  • Comfortable working in environments with significantly varying temperatures.

First 30, 60 and 90 Days

First 30 Days

  • Complete plant safety onboarding.

  • Obtain required lift-equipment certifications.

  • Complete training on the facility’s autonomous and progressive maintenance standards.

First 60 Days

  • Develop familiarity with the plant’s equipment and machinery layouts.

  • Begin independently completing scheduled preventive maintenance activities within the CMMS.

First 90 Days

  • Respond confidently to live equipment breakdowns.

  • Independently diagnose and repair common mechanical failures.

  • Collaborate effectively across departments and shifts to minimize production downtime.

Compensation and Benefits

  • $38.77 per hour.

  • Equivalent to approximately $80,642 annually based on a standard 40-hour working week.

  • Healthcare coverage.

  • Retirement benefits.

  • Paid time off.

  • Benefits are provided in accordance with the applicable Collective Bargaining Agreement and may be subject to eligibility requirements.

  • No bonus or commission.

  • No relocation assistance or interview travel reimbursement.

 

Senior Quality Engineer – Design Assurance | Medical Devices | Limerick, Ireland

Senior Quality Engineer – Design Assurance

📍 Location: Limerick, Ireland
🏢 Work Model: Hybrid – Minimum 4 days onsite
💼 Employment Type: Full-Time
💰 Salary: €60,000 – €70,000
✈️ Travel: Occasional
🎓 Education: Bachelor’s Degree in Engineering or related discipline preferred

Role Overview

A global medical technology organization is seeking a Senior Quality Engineer – Design Assurance to support new product development and sustaining engineering projects.

In this role, you will act as the Quality representative on cross-functional project teams, ensuring that products meet global regulatory requirements and internal quality standards throughout the entire product lifecycle—from concept and development through product launch and ongoing support.

You will play a critical role in design controls, risk management, verification & validation, and regulatory compliance, helping deliver high-quality medical technologies that improve patient care.

Key Responsibilities

Design Assurance & Product Development

  • Represent the Quality function on project core teams for new product development and design change projects

  • Support product lifecycle activities from concept through launch and maintenance

  • Ensure compliance with design control, risk management, and change control processes

Risk Management & Compliance

  • Lead risk management activities throughout the product development lifecycle

  • Support compliance with key standards such as:

    • ISO 13485

    • ISO 14971

    • IEC 60601

    • IEC 62304

    • EU MDR

  • Ensure regulatory requirements are integrated into development activities

Verification & Validation

  • Support development and execution of verification and validation (V&V) strategies

  • Review and approve test plans, protocols, and reports

  • Evaluate statistical approaches and challenge testing methodologies where necessary

  • Authorise and assess deviations during testing activities

Documentation & Quality Systems

  • Contribute to the creation and maintenance of Design History File (DHF) documentation

  • Support Quality Management System (QMS) activities including:

    • CAPA investigations

    • Field assessments

    • Operational engineering evaluations

  • Ensure accurate documentation and traceability across development programs

Issue Management & Continuous Improvement

  • Support failure investigations and root cause analysis

  • Manage software issue tracking in accordance with IEC 62304

  • Promote a strong quality culture across project teams

Required Qualifications

  • Bachelor’s degree in Engineering or related technical discipline
    (Equivalent experience considered)

  • Minimum 5+ years of experience in Quality Engineering within a regulated environment

  • Strong knowledge of:

    • ISO 13485

    • QSR / FDA quality requirements

    • ISO 14971 risk management

    • Statistical analysis techniques

  • Experience with:

    • Design assurance processes

    • Design controls and change control

    • Risk management methodologies

  • Strong written and verbal communication skills

  • Ability to manage multiple projects and priorities simultaneously

Preferred Experience

  • Experience with EU Medical Device Regulation (MDR)

  • Knowledge of:

    • IEC 62304 (medical device software lifecycle)

    • IEC 62366 (usability engineering)

  • Experience supporting software-enabled medical devices

  • Experience working with cross-functional product development teams

Ideal Candidate

The ideal candidate is a Quality Engineer experienced in regulated product development who:

  • Has strong expertise in design assurance and risk management

  • Understands the medical device regulatory landscape

  • Can effectively influence cross-functional engineering teams

  • Demonstrates strong attention to detail and analytical thinking

  • Promotes a patient-first approach to quality and compliance