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Contract Capa Engineer Jobs in Massachusetts (NOW HIRING)

Hologic Inc.

R&D Engineer 2

Marlborough, MA

Interface with manufacturing operations, suppliers, contract manufacturers, and internal ... Support regulatory submissions, audits, complaint investigations, CAPA activities, risk management ...

Hologic

R&D Engineer 2

Marlborough, MA · On-site

Interface with manufacturing operations, suppliers, contract manufacturers, and internal ... Support regulatory submissions, audits, complaint investigations, CAPA activities, risk management ...

Cirtec Medical

Sr. Quality Engineer 2nd Shift

Lowell, MA · On-site

$100K - $130K/yr

... a contract manufacturing environment. Key Responsibilities: * Provide Quality Engineering support ... CAPA (Corrective and Preventative Action) system owner or support responsible for the support of ...

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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 Massachusetts?

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

What are popular job titles related to Contract Capa Engineer jobs in Massachusetts?

For Contract Capa Engineer jobs in Massachusetts, the most frequently searched job titles are:

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

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

Contract Capa Engineer jobs near you

CAPA Quality Engineer - Murrysville PA OR Cambridge, MA (Onsite) // W2 Contract

APN Software Services, Inc

Cambridge, MA • On-site

$78K - $101K/yr

Other

Posted 5 days ago

Job description

Job Responsibilities:

Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring. Project manage all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines.

Represent CAPAs during audits and CAPA Review Board meetings.

Lead and mentor cross functional teams with the implementation of appropriate root cause analysis techniques (e.g. Pride problem solving).

Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.

Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.
Independently produces and completes CAPA (Corrective and Preventive Action) records.
Responsible for performing timely, detailed CAPA engineering tasks like assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis, and quality problem-solving.

Able to understand and analyze complex problems, including software and hardware design issues. Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations. Strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971. Demonstrated ability to partner with the business and effectively interact with and influence employees, and managers on all levels. Strong Project Management skills, including ability to project manage all CAPA activities. Ability to analyze data and apply statistical techniques. Koninklijke Philips N.V. Job Family Description Excellent written and verbal communication skills

Responsible for leading CAPA engineering activities like: assessing complex investigations and corrective actions and reviewing test and other complex performance data, leading complex root cause analysis and complex quality problem solving.

Bachelor s engineering degree with > 5 years of related experience, or a Master s degree with > 3 years of related experience.

Position Details:
These critical resources are being added to support the injunction lift and getting the CAPA program back to a healthy state.

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