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Fda Jobs in Wisconsin (NOW HIRING)

COATING PLACE LLC

QA Specialist I

Verona, WI · On-site

In-depth understanding of FDA 21 CFR regulations, ICH Guidelines, EU and Canadian GMPs. * Proficient in Microsoft Word, Excel, SharePoint, and Acrobat Professional. * Outstanding written, verbal, and ...

Oterra

Regulatory Affairs Manager

Mount Pleasant, WI · On-site

Monitor, interpret, and communicate changes to FDA, USDA, Health Canada, CFIA, California, and other applicable regulations affecting food colors and ingredients. * Evaluate regulatory risks and ...

Cadence Inc

Quality Assurance Engineer II

Sturgeon Bay, WI · On-site

$69K - $89K/yr

You will work closely with manufacturing, engineering, and regulatory teams to ensure compliance with ISO 13485, FDA, and other applicable medical device regulations. Your role supports new product ...

Domtar

Sr. Process Engineer

Rothschild, WI · On-site

$103K - $134K/yr

Manage internal FDA audit program and conduct internal audits to ensure FDA compliance. * Develop specifications and operating procedures for manufacturing processes of new and existing product lines.

Domtar

Sr. Process Engineer

Rothschild, WI · On-site

Manage internal FDA audit program and conduct internal audits to ensure FDA compliance. * Develop specifications and operating procedures for manufacturing processes of new and existing product lines.

Oterra

Regulatory Affairs Manager

Mount Pleasant, WI · On-site

Monitor, interpret, and communicate changes to FDA, USDA, Health Canada, CFIA, California, and other applicable regulations affecting food colors and ingredients. * Evaluate regulatory risks and ...

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How much do fda jobs pay per hour?

As of Sep 2, 2026, the average hourly pay for fda in Wisconsin is $35.93, according to ZipRecruiter salary data. Most workers in this role earn between $22.39 and $44.78 per hour, depending on experience, location, and employer.

What does an FDA professional do?

An FDA professional works for the U.S. Food and Drug Administration, a federal agency responsible for protecting public health by ensuring the safety and efficacy of drugs, medical devices, food, cosmetics, and other products. Their roles can include reviewing and approving new drugs and medical devices, conducting inspections, enforcing regulations, and providing guidance to industries. FDA professionals may also work in research, policy development, and public outreach to ensure that products meet regulatory standards and are safe for consumer use.

What are the key skills and qualifications needed to thrive as an FDA Regulatory Affairs Specialist, and why are they important?

To thrive as an FDA Regulatory Affairs Specialist, you need a strong background in life sciences, regulatory guidelines, and compliance, usually supported by a relevant degree such as pharmacy, biology, or chemistry. Familiarity with regulatory submission systems, FDA regulations (such as 21 CFR), and certifications like RAC (Regulatory Affairs Certification) are highly beneficial. Attention to detail, strong analytical thinking, and effective communication skills help professionals navigate complex regulations and collaborate with cross-functional teams. These competencies ensure that products meet legal requirements and safety standards, facilitating successful approvals and market access.

What are some typical challenges faced by professionals working at the FDA, and how can they be managed?

Professionals at the FDA often navigate complex regulatory requirements, tight deadlines, and the need to balance public health priorities with industry innovation. Collaborating across multidisciplinary teams and staying updated on evolving scientific data are essential parts of the role. Adapting to frequent changes in policy and handling high volumes of submissions can be demanding, but leveraging strong communication skills and seeking mentorship within the agency can help manage these challenges effectively.

What is the difference between Fda vs Food Scientist?

AspectFdaFood Scientist
Required CredentialsTypically a degree in health, science, or related field; certifications varyBachelor's or master's in food science, microbiology, or related
Work EnvironmentRegulatory agencies, laboratories, inspection sitesFood manufacturing facilities, laboratories, research settings
Employer & Industry UsageU.S. Food and Drug Administration, government agenciesFood companies, research institutions, government agencies
Common Search & Comparison IntentUnderstanding regulatory roles, compliance, and enforcementFood safety, product development, research

While both Fda professionals and Food Scientists work within the food industry, Fda roles focus on regulation, compliance, and enforcement of food safety laws, often within government agencies. Food Scientists primarily engage in research, product development, and ensuring food quality in manufacturing settings. The two careers overlap in food safety knowledge but differ in their primary responsibilities and work environments.

What qualifications do you need to work for the Food and Drug Administration?

To work for the Food and Drug Administration (FDA), candidates typically need a bachelor's degree in a relevant field such as science, engineering, or public health. For certain positions, advanced degrees or specialized certifications may be required, along with relevant work experience and knowledge of regulatory processes and compliance standards.

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

The most popular types of Fda jobs in Wisconsin are:

What are popular job titles related to Fda jobs in Wisconsin?

For Fda jobs in Wisconsin, the most frequently searched job titles are:

What job categories do people searching Fda jobs in Wisconsin look for?

The top searched job categories for Fda jobs in Wisconsin are:

What cities in Wisconsin are hiring for Fda jobs?

Cities in Wisconsin with the most Fda job openings:

Fda jobs near you
Infographic showing various Fda job openings in Wisconsin as of August 2026, with employment types broken down into 79% Full Time, 9% Part Time, and 12% Contract. Highlights an 100% In-person job distribution, with an average salary of $74,734 per year, or $35.9 per hour.

Integration (Process Validation) Engineer

Vonco Products LLC

Trevor, WI • On-site

Other

Re-posted 12 days ago

Job description

Job Description
Job Description
Description:

Integration (Process Validation) Engineer

Medical Device Contract Manufacturer – Flexible Films & Packaging


Position Summary

The Integration (Process Validation) Engineer is responsible for leading and supporting process validation and manufacturing integration activities for medical device packaging, flexible film converting, and related manufacturing processes. This role ensures manufacturing processes are developed, validated, transferred, and maintained in compliance with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, customer requirements, and internal quality standards.

The engineer will work cross-functionally with Operations, Quality, Design Engineering, and customers to support new product introductions, process improvements, equipment qualifications, and ongoing manufacturing validation activities.


Reporting Structure

• Reports To: VP of Quality and Integration Engineering

• Department: Integration Engineering


Essential Duties and Responsibilities

• Develop and execute IQ, OQ, and PQ validation protocols and reports.

• Lead validation activities for flexible film converting, RF welding, heat sealing, pouch manufacturing, printing, and labeling operations.

• Perform process capability studies and statistical analysis to support validation activities.

• Establish process windows, critical process parameters, and acceptance criteria.

• Support new product introductions (NPI) from concept through commercial production.

• Identify and implement process improvements focused on quality, efficiency, scrap reduction, and throughput.

• Lead root cause investigations and corrective actions related to process performance.

• Ensure compliance with FDA 21 CFR Part 820 / QMSR, ISO 13485, GMP requirements, and customer-specific quality requirements.

• Support internal, customer, and regulatory audits.

Project Management & Customer Communication

• Lead cross-functional project activities related to process validation, equipment implementation, and new product integration.

• Develop and manage project timelines, deliverables, and validation schedules to support customer and internal milestones.

• Coordinate activities between Engineering, Quality, Operations, Supply Chain, and customer teams to ensure successful project execution.

• Serve as a primary technical point of contact for customers during new product introductions, validation activities, process transfers, and ongoing manufacturing support.

• Communicate project status, technical risks, validation progress, and issue resolution plans to internal leadership and customers.

• Facilitate customer meetings, technical reviews, and validation planning discussions.

• Support quotation reviews and provide technical input related to manufacturability, process capability, and validation requirements.

• Collaborate with customers to understand product requirements, critical-to-quality characteristics, and regulatory expectations.

• Support customer visits, audits, factory acceptance activities, and production trials as needed.



Requirements:

Required Qualifications

• Bachelor’s degree in Engineering or related technical field required.

• 3+ years of engineering experience in a regulated manufacturing environment.

• Experience with process validation in regulated manufacturing.

• Working knowledge of IQ/OQ/PQ methodologies, statistical analysis, root cause analysis tools, and risk management methodologies.

• Knowledge of FDA 21 CFR Part 820 and ISO 13485 requirements.

• Strong technical writing and documentation skills.

Preferred Qualifications

• Experience in flexible films, medical packaging, or converting operations.

• Experience with RF welding, heat sealing, extrusion, laminating, pouch manufacturing, or printing technologies.

• Experience supporting customer audits and regulatory inspections.

• Experience with EQMS systems.

Key Competencies

• Strong analytical and problem-solving skills

• Project management and organizational skills

• Attention to detail and documentation accuracy

• Effective communication and collaboration skills

• Ability to manage multiple priorities in a fast-paced manufacturing environment

• Customer-focused mindset


Compensation details: 70000-85000 Yearly Salary


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