Manufacturing Quality EngineerActalent • Morton Grove, IL, US

Manufacturing Quality Engineer

Actalent • Morton Grove, IL, US

8 hours ago

Job type

Full-time

Job description

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Quality System Duties : (60%) o Lead the companies' quality assurance efforts in manufacturing o Establish and maintain the Quality Management System (QMS) o Maintain certification of the QMS to applicable standards as determined by executive management (e.g. FDA Quality System Requirements, ISO 13485, ISO 9001, etc.) o Establish and maintain the internal quality audit program o Establish and manage the companies' verification (inspection) activities including quality inspection staff o Develop and write QMS documents (procedures, work instructions, forms, etc.) and manage document control staff to publish and maintain the QMS controlled documents o Manage resolution of non-conformances including root cause determination, corrective / preventive action (CAPA) plan development and verification of effectiveness o Analyze and manage risk, using such tools at FMEA (Failure Mode and Effects Analysis) o Perform investigations to determine Root Causes and write reports, as required o Perform statistical analysis of processes and product conformance using methods such as Minitab "6-packs", and other statistical tools o Receive, respond to and manage process for resolving customer complaints o Perform and coordinate internal and external audits (certification, customer, and vendor audits) o Manage a staff of Quality Inspectors and Quality Administrator
Manufacturing Engineering Duties : (40%) o Develop and improve manufacturing processes o Qualify and validate production equipment and processes o Source and / or design equipment, accessories, and / or modifications o Perform equipment, facilities and utilities qualification o Source, test, and qualify new and alternative sources of materials o Maintain equipment documentation : Engineering drawings Qualification and validation records Operating manuals o Manage multiple concurrent projects in support of corrective, preventive and improvement actions

Description

MANUFACTURING QUALITY ENGINEER

Quality System Duties : (60%) o Lead the companies' quality assurance efforts in manufacturing o Establish and maintain the Quality Management System (QMS) o Maintain certification of the QMS to applicable standards as determined by executive management (e.g. FDA Quality System Requirements, ISO 13485, ISO 9001, etc.) o Establish and maintain the internal quality audit program o Establish and manage the companies' verification (inspection) activities including quality inspection staff o Develop and write QMS documents (procedures, work instructions, forms, etc.) and manage document control staff to publish and maintain the QMS controlled documents o Manage resolution of non-conformances including root cause determination, corrective / preventive action (CAPA) plan development and verification of effectiveness o Analyze and manage risk, using such tools at FMEA (Failure Mode and Effects Analysis) o Perform investigations to determine Root Causes and write reports, as required o Perform statistical analysis of processes and product conformance using methods such as Minitab "6-packs", and other statistical tools o Receive, respond to and manage process for resolving customer complaints o Perform and coordinate internal and external audits (certification, customer, and vendor audits) o Manage a staff of Quality Inspectors and Quality Administrator

Manufacturing Engineering Duties : (40%) o Develop and improve manufacturing processes o Qualify and validate production equipment and processes o Source and / or design equipment, accessories, and / or modifications o Perform equipment, facilities and utilities qualification o Source, test, and qualify new and alternative sources of materials o Maintain equipment documentation : Engineering drawings Qualification and validation records Operating manuals o Manage multiple concurrent projects in support of corrective, preventive and improvement actions

Skills

medical device manufacturing, iso13485, CAPA's, investigations, six sigma, flexible packaging, bilingual

Top Skills Details

medical device manufacturing,iso13485,CAPA's,investigations

Additional Skills & Qualifications

Skills and Experience Required :

Must have : o Proven track record of completing projects in a production environment o 2+ years' experience in a manufacturing environment o 2+ years' experience in a Quality Management System environment (ISO 13485 or ISO 9001 environment) o Experience with Minitab or equivalent statistical analysis software o Experience performing Process Capability (Cpk and Ppk) measurements and analysis o Experience in writing and managing controlled documents (specifications, work instructions, etc.) o Experience working with Corrective and Preventive Action (CAPA) systems and root cause investigation tools and writing reports o Experience with ANSI Z1.4 or equivalent inspection sampling plans o 2+ years' experience and proficiency in Minitab or equivalent statistical analysis software o Experience using 3-D CAD software (Alibre, SolidWorks, etc.) o Strong proficiency in MS Office software including Excel and Word

Experience Level

Intermediate Level

Pay And Benefits

The pay range for this position is $40.00 - $45.00 / hr.

Eligibility requirements apply to some benefits and may depend on your job

classification and length of employment. Benefits are subject to change and may be

subject to specific elections, plan, or program terms. If eligible, the benefits

Available For This Temporary Role May Include The Following

Medical, dental & vision

Critical Illness, Accident, and Hospital

401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available

Life Insurance (Voluntary Life & AD&D for the employee and dependents)

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

Time Off / Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Morton Grove,IL.

Application Deadline

This position is anticipated to close on Jul 25, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Engineering and Information Technology

Industries

Business Consulting and Services

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Quality Engineer Manufacturing • Morton Grove, IL, US