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Contract Capa Engineer Jobs in Wisconsin (NOW HIRING)

Project Manager-Senior Contract: 6 Months Location: Madison, WI Description: * We are currently ... Reporting to the Director of Engineering, the Technical Project Manager will be an engineering ...

Quality Assurance Associate

Middleton, WI

$23/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Support nonconformance, deviation, corrective and preventive action (CAPA), training, and complaint ... Job Type & Location This is a Contract position based out of Middleton, WI. Pay and Benefits The ...

New

Packaging Quality Specialist

Stevens Point, WI · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Our Business Adare Pharma Solutions is a global Contract Development and Manufacturing Organization ... We offer a variety of fields to embark in, including manufacturing, engineering, quality, chemistry ...

Quality Assurance Associate

Middleton, WI

$25/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Support nonconformance, deviation, corrective and preventive action (CAPA), training, and complaint ... Bachelor's degree in Biology, Chemistry, Engineering, Quality, or another STEM-related field.

New

Quality / Engineering Manager

Milwaukee, WI

$85K - $115K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

... contract, code, and customer requirements. Key responsibilities: * Provide direct leadership and ... Drive root cause analysis, corrective and preventive actions (CAPA), and non-conformance ...

WI · On-site

$90 - $130/hr

Reviews contracts for quality‑related requirements and compliance obligations * Develops and ... Bachelor of Science degree in Engineering or related field * 10+ years of experience in ...

WI · On-site

$150 - $210/hr

... Engineers, Quality Specialists, and Quality Inspectors across a multi-site campus. This position ... Foster and mentor strong Root Cause and Corrective Action, CAPA lifecycles, migrating shop floor ...

New

WI · On-site

$150 - $190/hr

... Engineers, Quality Specialists, and Quality Inspectors across a multi-site campus. This position ... Foster and mentor strong Root Cause and Corrective Action, CAPA lifecycles, migrating shop floor ...

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Senior Buyer

Sheboygan Falls, WI · On-site

$85K - $100K/yr

  • Medical

  • PTO

Partner closely with engineering, production, and operations teams to ensure material requirements ... Contract negotiation and supplier agreement management experience. * ERP experience with SAP or ...

WI · On-site

$106 - $132/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

... civil engineering, and structural construction, committed to driving a culture of quality and ... Conduct regular inspections in accordance with the established ITP, SSQP and contract requirements.

New

Showing results 21-40

Contract Capa Engineer information

What is a contract CAPA engineer?

A Contract CAPA Engineer is a professional hired on a temporary or project basis to manage and oversee Corrective and Preventive Action (CAPA) processes within an organization, typically in regulated industries such as pharmaceuticals, medical devices, or manufacturing. Their primary responsibility is to investigate issues, identify root causes, and implement solutions to prevent recurrence of non-conformities. They ensure that CAPA processes meet regulatory standards and help maintain compliance with industry guidelines. Contract CAPA Engineers often work with cross-functional teams to drive continuous improvement and ensure product quality.

What are the key skills and qualifications needed to thrive as a contract CAPA engineer?

To excel as a Contract CAPA Engineer, you need a strong background in quality engineering, root cause analysis, and regulatory compliance, often supported by a degree in engineering or a related field. Expertise in CAPA management systems, quality management software (like TrackWise), and knowledge of ISO 13485 or FDA regulations are typically required. Strong analytical thinking, attention to detail, and effective communication skills help drive successful corrective and preventive actions. These competencies ensure regulatory compliance, minimize risks, and maintain product quality in regulated industries.

What are some common challenges faced by a contract CAPA engineer when implementing corrective and preventive actions across multiple client sites?

As a Contract CAPA Engineer, one of the main challenges is adapting to different organizational processes and quality management systems at each client site. Each company may have unique documentation standards, regulatory requirements, and communication protocols, which can complicate the investigation and resolution of quality issues. Balancing multiple projects, aligning stakeholders, and ensuring timely closure of CAPA actions while strictly adhering to compliance standards requires strong organizational and interpersonal skills. Successful engineers proactively build rapport with client teams and remain detail-oriented to ensure all corrective and preventive actions are both effective and audit-ready.

What is the difference between Contract Capa Engineer vs Contract Failure Analysis Engineer?

AspectContract Capa EngineerContract Failure Analysis Engineer
Required CredentialsBachelor's in Engineering, Six Sigma, Root Cause AnalysisBachelor's in Engineering, Six Sigma, Root Cause Analysis
Work EnvironmentManufacturing, Aerospace, AutomotiveManufacturing, Aerospace, Automotive
Employer & Industry UsageQuality departments, Reliability teamsQuality departments, Reliability teams
Common Search & ComparisonYesYes

Both roles focus on quality and reliability, requiring similar certifications and working in manufacturing or aerospace industries. The Contract Capa Engineer primarily manages corrective and preventive actions to address issues, while the Contract Failure Analysis Engineer investigates root causes of failures. They often collaborate but serve distinct functions within quality assurance teams.

What are the most commonly searched types of Capa Engineer jobs in Wisconsin?

The most popular types of Capa Engineer jobs in Wisconsin are:

What job categories do people searching Contract Capa Engineer jobs in Wisconsin look for?

The top searched job categories for Contract Capa Engineer jobs in Wisconsin are:

Project Manager-Senior

Stellar IT Group

Madison, WI • On-site

Full-time

Posted 27 days ago


Job description

Overview:
Requisition Title: Project Manager-Senior
Contract: 6 Months
Location: Madison, WI
Description:
  • We are currently searching for a dynamic Technical Project Manager to join our Device Engineering and Operations team in Madison, WI.
  • Reporting to the Director of Engineering, the Technical Project Manager will be an engineering professional, responsible for leading technical projects through planning, scheduling, budget management, resource management for change control and stage gate projects in alignment with the department & SOPs in a matrix of cross functional groups.
  • Leads and delivers projects as a project management expert.
  • Will be responsible for project planning and management along with all activities needed for product development projects in accordance with design controls.
  • Follows operating mechanisms for monitoring project progress and for intervention and problem solving through collaboration with other technical team members.
  • Ensures project results meet requirements regarding technical quality, reliability, schedule, and cost.
  • Integrates with the project teams and facilitates discussions on technical and nontechnical problems throughout the life of the project.
  • Oversees and coordinates work performed by outside contractors.
  • Provides timely and accurate information and status updates to project stakeholders and management.
  • Participates in budget development and evaluating how project plan changes impact cost, resource requirements and schedule.

Essential Responsibilities:
  • Project Management
    - Lead and manage multiple sustaining engineering and fixture development projects, encompassing both hardware and software, from initiation through closure.
    - Leads risk assessment for technical and project related issues and developing mitigation plans to ensure appropriate mitigations are in place, to ensure schedule and costs are maintained.
    - Develop and maintain detailed project plans, timelines, budgets, and resource allocations. Tracks and manages project budgets, metrics, and resource utilization
    - Facilitate regular project meetings, track progress, and manage risks and issues.
    - Report out progress, issues and status at regular review meetings.
    - Ensure projects meet regulatory, quality, and business requirements.
    - Manages multiple concurrent projects and ensures timely progress reporting and escalation of issues impacting deliver
  • Cross-Functional Leadership
    - Collaborate with Product Development, Quality, Regulatory, Manufacturing, and Supply Chain teams.
    - Coordinate with external vendors and contract manufacturers as needed.
    - Serve as the primary point of contact for project status and communication.
    Sustaining Engineering
    - Manage engineering change orders, product updates, and obsolescence strategies.
    - Support root cause analysis and corrective/preventive actions (CAPA).
    - Drive cost reduction, reliability improvements, and design optimizations.
    Manufacturing Fixture Development
    - Oversee the design, validation, and implementation of manufacturing fixtures and tooling.
    - Ensure fixtures meet any ergonomic, safety, and regulatory standards.
    - Support process validation (IQ/OQ/PQ) and documentation.
  • Job Requirements:
    Education & Experience
    - Bachelors degree in Engineering, Biomedical Engineering, Computer Science, Mechanical Engineering, or related field.
    - 3+ years of project management experience in the medical device industry.
    - Experience with sustaining engineering and manufacturing support is a plus
    Skills & Competencies
    - Strong knowledge of FDA 21 CFR Parts 820, design controls, ISO 13485, and GMP.
    - Proficiency in project management tools (e.g., MS Project, Smartsheet, Jira).
    - Excellent communication, leadership, and organizational skills.
    - PMP certification or equivalent is a plus.
    - Familiarity with CAD tools and fixture design principles is a plus.

Skills:
project management