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Contract Capa Engineer Jobs in Tennessee (NOW HIRING)

Quality Engineer

Knoxville, TN · On-site

$68K - $88K/yr

Highly Competitive Plus Benefits Contract: Permanent, full time Reporting to: Director of Quality ... actions (CAPA). * Act as the primary point of contact for product development quality issues.

... Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that ... Provide SME knowledge for CAPA and deviations that occur during the manufacturing process * Support ...

... Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that ... Provide SME knowledge for CAPA and deviations that occur during the manufacturing process * Support ...

Project Engineer

Nashville, TN · On-site

$70 - $90/hr

... Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that ... Provide SME knowledge for CAPA and deviations that occur during the manufacturing process.

... Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that ... Provide SME knowledge for CAPA and deviations that occur during the manufacturing process * Support ...

Whether you're leading a team, engineering processes, or driving projects, your work ensures that ... From everyday essentials to seasonal items, what we do in Contract Logistics impacts businesses and ...

Whether you're leading a team, engineering processes, or driving projects, your work ensures that ... From everyday essentials to seasonal items, what we do in Contract Logistics impacts businesses and ...

This role works closely with the manufacturing, engineering, and supply chain teams to monitor ... Knowledge of corrective and preventive action (CAPA) processes * Proficiency with dimensional ...

This individual works closely with business, manufacturing, laboratory, quality, engineering, and ... Participate in vendor selection, contract review, service-performance evaluation, licensing ...

... Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that ... Partner with Manufacturing and Engineering on preventive maintenance and calibration scheduling to ...

New

... Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that ... Partner with Manufacturing and Engineering on preventive maintenance and calibration scheduling to ...

New

... Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that ... Partner with Manufacturing and Engineering on preventive maintenance and calibration scheduling to ...

New

... Engineering, Production, Quality and Purchasing. * Drive customer satisfaction and support customer ... Track and communicate On-Time Delivery (OTD), program profitability, launch milestones, CAPA ...

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

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

$70 - $90/hr

Other

Retirement

Posted 3 days ago

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Job description

About this position

Join us in our mission to commercialize fusion energy

Type One Energy Group is mission-driven to provide sustainable, affordable fusion power to the world. Established in 2019 and venture-backed in 2023, the company is led by a team of globally recognized fusion scientists with a strong track record of building state‑of‑the‑art stellarator fusion machines, together with veteran business leaders experienced in scaling companies and commercializing energy technologies.

If you are searching for the best new ideas and share our vision, join us as a Quality Engineer. This is what you need to know:

Location: Knoxville, TN

Salary: Highly Competitive Plus Benefits

Contract: Permanent, full time

Reporting to: Director of Quality Assurance

Your role in the mission:

Type One Energy is seeking a Quality Engineer (QE) to coordinate with Engineering and associated support functions for design assurance, supplier quality, prototype quality, traceability, verification, and validation.

This role will be central for effective implementation and compliance of the design execution and engineering review processes spanning the product development of critical components and systems to meet our technical, performance, and compliance requirements.

The ideal candidate will have the technical depth and professional maturity to operate independently while also collaborating closely with internal teams to integrate quality into design and prototyping decisions.

Responsibilities
  • Plan, execute, and document risk-based approach to product development quality planning in alignment with company and ISO 9001 quality management system requirements.
  • Evaluate design execution and engineering review processes to ensure compliance.
  • Coordinate quality planning with engineering technical lead and project manager to ensure system requirements traceability, interface requirements control, configuration validation, system performance verification, system commissioning validation/verification, and surveillance plan using a risk-based approach.
  • Establish, track, and report metrics associated with the quality plan.
  • Lead investigations into non-conformances, conducting root cause analysis and driving corrective and preventive actions (CAPA).
  • Act as the primary point of contact for product development quality issues.
  • Communicate and advocate quality expectations to Engineering, Operations, Procurement, and cross-functional stakeholders to enable success.
  • Partner with Supplier Quality and Procurement to integrate product quality requirements into sourcing decisions including product requirements flow down, acceptance criteria and methods, traceability, and product issues/nonconformities.
  • Contribute to the development, rollout, and continuous improvement of design/engineering quality processes, templates, and documentation.
  • Develop processes which are practical, effective, and scalable as the company grows from prototype to production.
  • Ensure design execution and engineering review processes align with ISO 9001 QMS.
  • Demonstrate proactive engagement with technical lead and project manager for audits, customer reviews, and regulatory inspections.
What you’ll need
  • Bachelor’s degree in Engineering, Quality, or a related technical discipline.
  • 5+ years of experience in quality engineering or supplier quality engineering roles in a product development, manufacturing, aerospace, energy, or high‑technology environment.
  • Knowledge of product lifecycle processes for concept through development to production for effective transition from design to ensure system-level quality requirements are met.
  • Demonstrated experience employing quality engineering tools and risk-based design and manufacturing processes (e.g., APQP, PPAP, FMEA).
  • Strong understanding of quality management systems (ISO 9001 or equivalent).
  • Experience with configuration control, validation, and verification in highly regulated and compliance frameworks with global supply chains.
  • Hands‑on experience with root cause analysis, corrective actions, and issue resolution.
  • Excellent communication and negotiation skills, with the ability to build strong relationships and influence cross‑functional stakeholders.
  • Ability to travel to supplier sites as required.
Preferred Qualifications
  • Certified Quality Engineer (CQE) or similar professional certification.
  • Knowledgeable and experienced with complex/sophisticated electro‑mechanical products manufacturing or equipment fabrication that includes software and hardware development.
  • Demonstrated success in effectively navigating and collaborating large and distributed functional matrix organizations (e.g. Programs, Engineering, Operations, Quality, Supply Chain).
  • Quality or Engineering experience using new product introduction (NPI) or product development processes in energy, aerospace & defense, or advanced manufacturing industries.
  • Working knowledge of AS9100, ISO 13485, or other regulated quality standards.
  • Experience in rapidly scaling organizations or new product introduction (NPI) environments.
We offer
  • A hybrid work policy
  • Stock options
  • Insurance plans
  • Retirement options
  • And many more great voluntary benefits

Type One Energy applies proven advanced manufacturing methods, modern computational physics and high‑field superconducting magnets to develop its optimized stellarator fusion energy system. Our FusionDirect development program pursues the lowest‑risk, shortest‑schedule path to a fusion power plant over the coming decade, using a partner‑intensive and capital‑efficient strategy.

Type One Energy is committed to community engagement in the development and deployment of its clean energy technology. For more information, visit www.typeoneenergy.com or follow us on LinkedIn.

Equal Opportunity Statement

Type One Energy is an equal opportunity employer. We value diversity, searching for the best new ideas and remaining open to unique perspectives. Therefore, all qualified applicants will receive consideration for employment independent of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age, or any other characteristics protected by applicable federal, state, or local laws. All qualified individuals are encouraged to apply.

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