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Remote Capa Engineer information

What are the key skills and qualifications needed to thrive as a Remote CAPA Engineer, and why are they important?

To thrive as a Remote CAPA (Corrective and Preventive Action) Engineer, you need a solid background in quality engineering, root cause analysis, and regulatory compliance, often supported by a degree in engineering or a related field. Familiarity with quality management systems (such as ISO 13485 or FDA 21 CFR Part 820), CAPA software, and data analysis tools is typically required. Strong attention to detail, problem-solving skills, and effective virtual communication set standout professionals apart. These skills ensure accurate issue resolution, regulatory adherence, and seamless collaboration in distributed work environments.

How does a Remote CAPA Engineer typically collaborate with cross-functional teams to resolve quality issues?

As a Remote CAPA (Corrective and Preventive Action) Engineer, you’ll regularly work with quality assurance, manufacturing, R&D, and regulatory teams to identify, investigate, and resolve quality concerns. Collaboration often involves virtual meetings, sharing documentation, and following up on action items remotely. Effective communication skills and a proactive approach are crucial for driving investigations, ensuring timely implementation of corrective actions, and verifying their effectiveness. Building strong relationships across departments helps streamline issue resolution and fosters a culture of continuous improvement, even in a remote work setting.

What is a Remote CAPA Engineer?

A Remote CAPA (Corrective and Preventive Action) Engineer is a professional responsible for identifying, investigating, and resolving quality issues within an organization, often working from a remote location. They analyze data, implement corrective and preventive measures, and ensure compliance with industry standards and regulations. Their work is crucial in maintaining product quality and safety, as well as continuous improvement in processes. Remote CAPA Engineers utilize digital tools and communication platforms to collaborate with cross-functional teams and document their findings.

What is the difference between Remote Capa Engineer vs Remote Quality Engineer?

AspectRemote Capa EngineerRemote Quality Engineer
CredentialsISO 13485, FDA regulations, Six SigmaISO 9001, Six Sigma, QA certifications
Work EnvironmentMedical device, pharmaceutical, biotech industriesManufacturing, software, product development
Industry UsagePrimarily healthcare and biotech sectorsBroad across manufacturing, tech, and software
Common Search IntentRegulatory compliance, CAPA processes, medical device qualityProduct quality, testing, process improvement

Remote Capa Engineers focus on managing corrective and preventive actions in regulated industries like healthcare, ensuring compliance with standards such as ISO 13485. Remote Quality Engineers work across various sectors to improve product quality through testing and process improvements. While both roles emphasize quality management, the industry focus and specific certifications differ.

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 are popular job titles related to Remote Capa Engineer jobs in Wisconsin? For Remote Capa Engineer jobs in Wisconsin, the most frequently searched job titles are:
What job categories do people searching Remote Capa Engineer jobs in Wisconsin look for? The top searched job categories for Remote Capa Engineer jobs in Wisconsin are:
What cities in Wisconsin are hiring for Remote Capa Engineer jobs? Cities in Wisconsin with the most Remote Capa Engineer job openings:
Remote Capa Engineer jobs near you
Quality Auditor - Pharmaceutical/Medical Device

Quality Auditor - Pharmaceutical/Medical Device

SQA Services

Milwaukee, WI • Remote

$1.30K/day

Other

Posted 15 days ago

Job description

For nearly 30 years, SQA Services has been a leading provider of managed supplier quality services, offering audits, assessments, remote surveillance, corrective actions, remediation, inspections, and engineering solutions to manufacturers across all industries. We deliver these services by deploying a network of highly skilled associates based throughout the United States and in over 90 countries worldwide, ensuring rapid on-site support at your supplier locations. Our associates are expert quality assurance professionals with extensive experience and local expertise, enabling us to represent our clients on-demand and with greater speed and efficiency than our competitors.
 
We're hiring a Pharma Quality Auditor. This is a contract opportunity in which you will perform supplier quality  audits at various suppliers in Japan. These audits are generally 1-2 days long. You are given the flexibility to accept or reject these assignments according to your own availability. 
Key Responsibilities
  • Perform supplier audits at various sites within your region of residence
  • Assure quality in the supply chains of various clients within the pharmaceutical, medical device, cosmetics, biologics, and/or animal health industries
  • Coordinate, prepare, execute, and deliver supplier audits based on your own and the client schedule
  • Utilize your regulatory knowledge of various standards from ISO, CFR, FDA, etc...
  • Respond to the Content team in a timely manner regarding edits/questions to your audit report
  • Write audit reports in accordance with client specifications
Required Qualifications
  • 5+ years of hands-on audit experience in pharmaceutical, medical device, and/or biologics industries
  • Has been the lead auditor in at least 10 audits
  • Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820
  • Strong communication and writing skills
  • Proven ability to deescalate workplace conflicts effectively
  • Ability to adapt to new technology and software.
  • Willingness to travel regionally
Preferred Qualifications
  • Direct audit experience to ISO 17025, ISO 15378, IPEC GDP, ICH Q7 and/or Canada GMP
  • ISO certifications are a plus but not mandatory
$1,300 - $1,300 a day
Pay Rate: 
 
$1300 for a 1-day audit. Includes: Time spent preparing for the audit, traveling, performing the audit, writing the report, and responding to questions from our Content team of editors and the client until the report is finalized. Does not include: Following up on CAPA for any findings or reimbursement for travel expenses - expenses are reimbursed at cost with receipts per SQA travel policy. Note that SQA helps with the preparation of the audit and proofreads all audit reports.
 
Note: SQA is an Equal Opportunity Employer. Employment is based on merit and qualifications, and is not influenced by race, color, religion, gender, national origin, veteran status, disability, age, sexual orientation, gender identity, marital status, or any other legally protected status.
 
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We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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