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Validation Engineer - Croswell Area
The Pivot Group Network
Croswell · Croswell, MI
Quality Assurance Engineer, Quality Engineer, Process Validation Engineer, Equipment Qualification Engineer, Compliance Engineer, Manufacturing Quality Engineer, Test Engineer, Computer…
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Estimator - Monroe Area
The Pivot Group Network
Monroe · Monroe, MI
Maintain estimating records and cost history in the company system.
Added just now
Validation Engineer - Ann Arbor Area
The Pivot Group Network
Ann Arbor · Ann Arbor, MI
Process Validation Engineer, Equipment Qualification Engineer, Compliance Engineer, Manufacturing Quality Engineer, Test Engineer, Computer System Validation Specialist, Regulatory Affairs…
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Estimator - Detroit Area
The Pivot Group Network
Detroit · Detroit, MI
Maintain estimating records and cost history in the company system.
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Quality Supervisor - Coldwater Area
The Pivot Group Network
Coldwater · Coldwater, MI
Maintain and audit the quality management system.
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Six Sigma Black Belt - Wixom Area
The Pivot Group Network
Wixom · Wixom, MI
Run design of experiments and measurement system studies.
Added just now
Six Sigma Black Belt - Croswell Area
The Pivot Group Network
Croswell · Croswell, MI
Run design of experiments and measurement system studies.
Added just now
Senior Manufacturing Test Engineer, Amazon Leo OISL
Amazon Kuiper Manufacturing Enterprises LLC
Redmond, WA
As a Senior Test Engineer for the OISL Manufacturing Team, you will be responsible for the end-to-end Electrical testing process for a Line-Replaceable-Unit, from initial concept through…
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Assistant ITS Program Coordinator
Department of Transportation
CA
- $6,031 to $7,547 USD / month
Under the direction of the Senior Transportation Electrical Engineer of the Office of Intelligent Transportation Systems (ITS) Engineering and Support, the incumbent independently plans,…
Added 1 min ago
Embedded Controls Engineer, Airborne Electronic Hardware
BETA Technologies
Raleigh, NC
The Embedded Controls Engineer - AEH will work as part of a multidisciplinary team developing products for use in BETA’s electric aircraft and customer platforms. As a Embedded Controls…
Added 2 mins ago
CRM Lead Engineer
The Mental Health Association of NYC, Inc. dba Vibrant Emotional Health
Remote, United States
The CRM Lead Engineer – Platform Engineering provides hands-on engineering leadership for an assigned Salesforce CRM platform. This role leads the engineers supporting the platform and is…
Added 2 mins ago
Water Treatment Construction Technician for Data Centers
Garratt Callahan Co
Charleston, SC
…perform water treatment lab work, commission new piping and system assets, and troubleshoot water treatment and control equipment at the customer's massive data…
Added 2 mins ago
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Bilingual Senior Database Engineer (DBA)
Jobot
Montebello, CA
- $80,000 to $100,000 USD / year
If you are a Bilingual (English/Mandarin) Senior Database Engineer (DBA) and want to join a growing, tech-savvy E-Commerce company with a dynamic team then apply now!
Added 2 mins ago
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Systems Integration Engineer - (CAS / COTS)
Jobot
Egg Harbor Township, NJ
- $130,000 to $175,000 USD / year
Systems Integration Engineer – RHEL, Linux, Ansible, Bash & COTS Integration | Mission-Critical Aviation Systems
Added 2 mins ago
I&C Platform Engineer
Westinghouse Electric Company, LLC
Warrendale, OR
The Common Q+ Engineer supports the Common Q platform as a foundation for the future of Instrumentation and Control (I&C). This role ensures the platform is properly maintained and that…
Added 2 mins ago
Senior Project Engineer
Westinghouse Electric Company, LLC
Jenkinsville, SC
As a Senior Project Engineer you will support the planning, coordination, integration, and execution of engineering activities in support of the VC Summer project. You will help ensure…
Added 3 mins ago
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Senior Electrical Controls Engineer
Signode
Forest, VA
- $90,000 to $125,000 USD / year
The Senior Electrical Controls Engineer will conceptualize, design, program, test, and document various updated and new automation equipment products, including equipment used for…
Added 3 mins ago
Quality Manager - Iron Mountain Area
The Pivot Group Network
Iron Mountain · Iron Mountain, MI
Lead the plant quality management system and keep it compliant with ISO 9001 and customer requirements.
Added 3 mins ago
PLC Programmer - Flint Area
The Pivot Group Network
Flint · Flint, MI
Troubleshoot PLC and control system issues on the production floor.
Added 3 mins ago
Field Service Technician - Sault Ste. Marie Area
The Pivot Group Network
Sault Ste. Marie · Sault Ste. Marie, MI
Troubleshoot mechanical, electrical, and control system faults on site.
Added 3 mins ago
IATF Quality Engineer - Shelby Township Area
The Pivot Group Network
Shelby Township · Shelby Township, MI
Are you a forward-thinking professional with a passion for excelling as a iatf quality engineer? The Pivot Group Network, a Michigan manufacturing-focused recruiting group, is committed to…
Added 3 mins ago
Field Service Technician - Shelby Township Area
The Pivot Group Network
Shelby Township · Shelby Township, MI
Troubleshoot mechanical, electrical, and control system faults on site.
Added 3 mins ago
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Automation Engineer
Nicolet National Bank
Twin Cities, MN
- $80,000 to $100,000 USD / year
…determine the most appropriate automation approach, such as APIs, system integrations, workflow automation, RPA, data pipelines, or native application capabilities. The Automation Engineer…
Added 3 mins ago
Automation Engineer
Nicolet National Bank
Downtown, IA
…determine the most appropriate automation approach, such as APIs, system integrations, workflow automation, RPA, data pipelines, or native application capabilities. The Automation Engineer…
Added 4 mins ago
McWane Ductile Ohio - 3rd Shift Superintendent
McWane, Inc.
Coshocton, OH
Track downtime, recurring failures, repairs and unresolved risks; report equipment status and performance to the Plant Engineer.

Actalent

Quality Engineer Nonconformance & CAPA

Irvine, CA, United States

$40 to $55 USD / hour

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Job details

Pay: $40 to $55 USD / hour
Posting language: English
Posted: Nov 2, 2026

Original job description

Job Title: Quality EngineerJob DescriptionThe Quality Engineer supports quality activities within an on-site manufacturing operation, with primary responsibility for investigating and documenting manufacturing nonconformances across two production business units. The role focuses on identifying root causes of manufacturing and product issues, assessing impacted products and lots, and driving timely, compliant resolutions in a regulated environment.Responsibilities

Own and perform nonconformance investigations related to manufacturing and product quality issues across two production business units.
Conduct thorough root cause analysis to determine the source of manufacturing discrepancies and quality events.
Write clear, technically sound investigation reports that document findings, root cause, impacted lots and products, and recommended actions.
Support approximately four nonconformance closures per week, adapting to varying investigation complexity, timelines, and related change controls.
Partner with upstream and downstream teams to investigate issues across the entire manufacturing process, from raw materials to finished products.
Analyze manufacturing and quality data using tools such as Excel, Power BI, and PI Vision to identify trends, risks, and improvement opportunities.
Work cross-functionally with Operations, Quality, Manufacturing Engineering, supervisors, technicians, and production personnel to resolve quality issues.
Maintain complete, accurate, and compliant investigation documentation in accordance with applicable quality system requirements and good documentation practices (GDP).
Support and participate in CAPA activities, including risk mitigation and implementation of corrective and preventive actions stemming from investigations.
Contribute to and support change control processes associated with manufacturing and quality improvements.
Review drawings, procedures, and related technical documentation to ensure quality requirements are clearly defined and met.
Apply knowledge of regulatory expectations, including FDA and ISO-related requirements, within a medical device or pharmaceutical manufacturing context.
Support audits and internal quality assurance activities as needed.
Collaborate with cross-functional teams to continuously improve nonconformance investigation processes and overall product quality.

Essential Skills

Bachelor's degree in an engineering discipline or a related technical field.
Minimum 12+ years of professional industry experience after graduation.
13 years of experience within medical device or pharmaceutical manufacturing, or another regulated manufacturing environment.
Hands-on experience conducting nonconformance, NCR, NCMR, or deviation investigations, including ownership of investigations rather than only participation.
Demonstrated experience performing structured root cause analysis.
Experience with CAPA, risk mitigation, and change control in a manufacturing or production environment.
Proven ability to write high-quality technical investigation reports and other quality documentation.
Strong technical writing skills with attention to clarity, accuracy, and compliance with GDP.
Strong problem-solving skills with the ability to analyze complex manufacturing and quality issues.
Effective cross-functional communication skills, including the ability to work closely with Operations, Quality, Manufacturing Engineering, and production teams.
Experience supporting a manufacturing or production environment, including interaction with technicians, supervisors, and engineering staff.
Proficiency with Excel for data analysis and reporting.
Familiarity with FDA-regulated or ISO-based quality systems and quality engineering or quality assurance practices.

Additional Skills & Qualifications

Experience within medical device or pharmaceutical manufacturing environments is strongly preferred.
Exposure to or experience with Power BI and PI Vision for data visualization and analysis.
Experience in quality engineering, quality assurance, or related engineering disciplines.
Experience with audits in regulated manufacturing environments.
Knowledge of ISO standards relevant to quality systems and medical products.
Experience managing and documenting nonconformances, including NCMR and NCR processes.
Experience supporting investigations that lead to CAPA and change control activities.
Ability to interpret and review engineering drawings, procedures, and related technical documentation.
Comfort working in a growth-oriented organization with evolving processes and continuous improvement initiatives.
Interest in long-term assignment opportunities, with potential for a 12month contract and possible extension based on performance and business needs.

Work EnvironmentThis position is based on-site in a manufacturing environment that develops, manufactures, and markets innovative medical products and services for the healthcare industry. The facility focuses on products with inherent safety features that help address critical healthcare challenges, including opioid abuse issues, hospital-acquired malnutrition, and hazardous drug exposure. You will work closely with a large, diverse operations and quality team that includes technicians, supervisors, and engineering staff who manage raw materials, in-process work, and finished products. The environment is highly regulated and quality-focused, with established quality systems, FDA and ISO expectations, and strong emphasis on data-driven decision-making using tools such as Excel, Power BI, and PI Vision. The role involves regular interaction on the production floor, review of drawings and procedures, and participation in cross-functional projects. This is a 12month contract assignment with the potential to extend, offering the opportunity to contribute to a market-leading organization in a growth phase while supporting meaningful healthcare-focused products Job Type & LocationThis is a Contract to Hire position based out of Irvine, CA. Pay and BenefitsThe pay range for this position is $40.00 - $55.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.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) Job Type & LocationThis is a Contract to Hire position based out of Irvine, CA. Application DeadlineThis position is anticipated to close on Nov 13, 2026. Workplace TypeThis is a fully onsite position in Irvine,CA.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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

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