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Freelance Medical Device Labeling Jobs in Wisconsin

Otsuka

Neuroscience Specialist-Greenbay, WI

Oshkosh, WI · On-site

Conduct proactive outreach to HCPs on topics such as product access, on-label information, and ... Must have at least one of the following experiences: * 2+ years of pharmaceutical or medical device ...

Abbott Laboratories

WI · On-site

$59.17 - $93.31/hr

Support labeling, packaging, shelf-life extension, demo creation, product disposition, and related ... Experience within the medical device, healthcare, pharmaceutical, or regulated manufacturing ...

MPE-Inc

Production Supervisor - 2nd Shift

Milwaukee, WI · On-site

$80K - $95K/yr

... labeling and accurate tracking and transfer of material movement. * Participate in root cause ... a medical device or regulated manufacturing environment. * High School diploma or equivalent

Biopharma Careers

WI · On-site

$145 - $215/hr

PromoteTavneoswithin approved labeling in a fair, balanced, and ethical manner in accordance with ... Associate degree and 6 years of sales experience within pharmaceutical, biotech or medical device ...

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Freelance Medical Device Labeling information

What is freelance medical device labeling?

Freelance medical device labeling involves independent professionals who create, review, and manage the labels and instructions that accompany medical devices. These labels must meet strict regulatory requirements to ensure patient safety and regulatory compliance. Freelance specialists may work with manufacturers to develop compliant packaging, user manuals, and product inserts for various markets. They need to be knowledgeable about international regulations and guidelines, such as those from the FDA or the European MDR. This role often requires attention to detail, regulatory expertise, and clear communication skills.

What are the key skills and qualifications needed to thrive as a freelance medical device labeling specialist?

To thrive as a Freelance Medical Device Labeling Specialist, you need expertise in regulatory requirements, medical terminology, and technical writing, often supported by a background in life sciences or regulatory affairs. Familiarity with labeling management systems, document control software, and knowledge of FDA, EU MDR, or ISO standards is typically required. Attention to detail, strong organizational skills, and clear communication are essential soft skills to ensure accuracy and compliance. These skills are critical for producing precise, regulation-compliant labeling that ensures patient safety and successful product approval.

What are some common challenges freelance medical device labeling specialists face when collaborating with multiple clients?

Freelance medical device labeling specialists often navigate varying regulatory requirements and documentation standards from different clients, which can be challenging. Each client may use different systems for document management and have unique internal review processes, requiring adaptability and strong organizational skills. Additionally, balancing multiple projects with tight deadlines demands effective time management to ensure all labeling materials remain compliant and up to date. Proactive communication and a thorough understanding of regional regulations are crucial for successful collaboration and project delivery.

What are the most commonly searched types of Medical Device Labeling jobs in Wisconsin?

The most popular types of Medical Device Labeling jobs in Wisconsin are:

What are popular job titles related to Freelance Medical Device Labeling jobs in Wisconsin?

For Freelance Medical Device Labeling jobs in Wisconsin, the most frequently searched job titles are:

What job categories do people searching Freelance Medical Device Labeling jobs in Wisconsin look for?

The top searched job categories for Freelance Medical Device Labeling jobs in Wisconsin are:

What cities in Wisconsin are hiring for Freelance Medical Device Labeling jobs?

Cities in Wisconsin with the most Freelance Medical Device Labeling job openings:

Freelance Medical Device Labeling jobs near you

Integration (Process Validation) Engineer

Vonco Products LLC

Trevor, WI • On-site

Other

Re-posted 16 days ago

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

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PI286676591

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