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Quality Manager Medical Device Jobs in Boca Raton, FL

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... the quality system including but not limited to support in conducting risk analysis, closing ... the medical device industry. • 3+ years in a leadership role within product development ...

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Medical Device Rep

Boca Raton, FL · On-site

$82K - $113K/yr

Medical Sales Territory Representative - Entry Level We are a leading Medical Device and Equipment ... Ability to effectively manage a physician-based customer base * Skills to communicate clinically ...

Manages the Quality Engineering team to support new product development, process quality, CAPA ... Excellent working knowledge of medical device regulations and industry standards pertaining to ...

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Participate in change management, internal audits, supplier quality initiatives, and continuous ... Minimum 3-5 years of professional quality experience within medical device, veterinary product ...

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Participate in change management, internal audits, supplier quality initiatives, and continuous ... Minimum 3-5 years of professional quality experience within medical device, veterinary product ...

The Sr. Manager of Quality Assurance leads the Quality Operations and Quality Engineering teams to ... EU Medical Device Directive (93/42/EEC); Canadian Medical Devices Regulation (SOR98-282); Japanese ...

Quality Engineer

Davie, FL

$66K - $85K/yr

Manages engineering projects. Supports the internal and external audit program. Uses statistical ... A minimum of 5 years' experience in the medical device manufacturing industry is preferred.

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Quality Manager Medical Device information

See Boca Raton, FL salary details

$22.8K

$81.8K

$149.9K

How much do quality manager medical device jobs pay per year?

As of Jul 31, 2026, the average yearly pay for quality manager medical device in Boca Raton, FL is $81,762.00, according to ZipRecruiter salary data. Most workers in this role earn between $41,800.00 and $129,100.00 per year, depending on experience, location, and employer.

What does a Quality Manager do in the medical device industry?

A Quality Manager in the medical device industry is responsible for ensuring that products meet all regulatory requirements and quality standards throughout their lifecycle. They develop, implement, and monitor quality management systems, oversee internal and external audits, and work closely with manufacturing, engineering, and regulatory teams to maintain compliance with standards such as ISO 13485 and FDA regulations. Their role is critical to ensuring patient safety and product efficacy by preventing defects and ensuring consistent quality.

What are some common challenges Quality Managers face when ensuring compliance in the medical device industry?

Quality Managers in the medical device industry often encounter challenges such as keeping up with evolving regulatory requirements (like FDA, ISO 13485, and MDR), coordinating cross-functional teams to maintain strict quality standards, and managing documentation for audits. They must also address nonconformities quickly and implement corrective and preventive actions to avoid product recalls. Effective communication and strong attention to detail are essential for navigating these challenges while maintaining product safety and regulatory compliance.

What is the difference between Quality Manager Medical Device vs Quality Engineer Medical Device?

AspectQuality Manager Medical DeviceQuality Engineer Medical Device
Primary FocusOversees quality systems, compliance, and team managementDesigns, develops, and implements quality testing and inspection processes
CertificationsISO 13485, Six Sigma, Lead AuditorISO 13485, Six Sigma, Certified Quality Engineer (CQE)
Work EnvironmentManagement, regulatory compliance, cross-department collaborationProduct testing, process improvement, technical analysis
Industry UsageUsed across organizations to ensure overall quality managementUsed in product development and testing phases

The main difference is that the Quality Manager Medical Device focuses on managing quality systems and compliance at a strategic level, while the Quality Engineer Medical Device concentrates on technical testing and process improvements. Both roles require similar certifications and work within the same industry but serve different functions within quality assurance.

What are the key skills and qualifications needed to thrive as a Quality Manager in the Medical Device industry, and why are they important?

To thrive as a Quality Manager in the Medical Device industry, you need a solid background in quality assurance, regulatory compliance (such as ISO 13485 and FDA 21 CFR Part 820), and process improvement, often supported by a relevant degree in engineering or life sciences. Familiarity with quality management systems (QMS), risk management tools (like FMEA), and certifications such as ASQ Certified Quality Auditor (CQA) or Six Sigma are typically required. Strong leadership, attention to detail, and effective communication are vital soft skills for managing teams and ensuring cross-functional alignment. These skills and qualifications are crucial to ensure product safety, regulatory compliance, and the overall success of medical device manufacturing and delivery.
What are popular job titles related to Quality Manager Medical Device jobs in Boca Raton, FL? For Quality Manager Medical Device jobs in Boca Raton, FL, the most frequently searched job titles are:
What job categories do people searching Quality Manager Medical Device jobs in Boca Raton, FL look for? The top searched job categories for Quality Manager Medical Device jobs in Boca Raton, FL are:
What cities near Boca Raton, FL are hiring for Quality Manager Medical Device jobs? Cities near Boca Raton, FL with the most Quality Manager Medical Device job openings:
Infographic showing various Quality Manager Medical Device job openings in Boca Raton, FL as of July 2026, with employment types broken down into 59% Full Time, 33% Part Time, and 8% Contract. Highlights an 100% In-person job distribution, with an average salary of $81,762 per year, or $39.3 per hour.

Product Development Manager - Medical Device

Medical Device Manufacturing Co

Pompano Beach, FL • On-site

$107K - $134K/yr

Full-time

Medical, Dental, Vision, Life, PTO

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Job description

Departmental Manager providing direct management of engineers, supervisors, and technicians. Allocates resources based upon departmental plans & budgets. Responsible for hire/fire decisions within their department. Submits departmental budgets, performance / productivity targets and reports on results. Measured against performance plan goals and objectives.


The primary role of the Product Development Manager is to plan, organize and direct engineers to meet company objectives for design, development of new products and make improvements to existing products by performing the following duties personally or through subordinates. This manager ensures that all engineering activities are completed on time and conform to the standards as established by design control procedures.


Duties and Responsibilities:

• Supervise the team of engineers within the product development department.

• Responsible for the development of new products as determined by the company’s product development roadmap. Continually researches for new methods or components to enhance or improve existing products.

• Prepare and/or review engineering change requests; coordinate cross functional teams to determine feasibility, develop and oversee preparation and implementation of all engineering change notices and document change control.

• Responsible for maintaining and implementing processes and procedures covered by design control.

• Assist quality and compliance in the implementation of the quality system including but not limited to support in conducting risk analysis, closing customer complaints, CARs, internal audits, and other activities covered by the quality system.

• Assist manufacturing operations with development of processes, tooling, molds, and design transfer necessary to produce new products.

• Provide customer service and sales & marketing departments with orientation and training on new products, and assist with preparation of sales presentations, service/repair methods, and marketing literature.

• Perform other duties as assigned.


Required Qualifications:

• Bachelor’s degree in mechanical engineering.

• Minimum 5+ years of engineering experience within the medical device industry.

• 3+ years in a leadership role within product development, engineering, design, etc.

• Experience with GMP and other regulatory compliance requirements.

• Experience with design & development of medical devices within a design control process.

• Prior hands-on customer interaction and proven experience understanding the voice of the customer.

• Change management: willing to make hard fact-based decisions, comfortable with anuninstructed and changing environment.

• Skilled at developing new ideas from both a product and process perspective.

• Demonstrated practical application of design FMEA, value engineering, and design for manufacturability concepts.

• Extensive experience in 3D CAD modeling and 2D dimensioning using Solidworks.


Physical / Mental Demands:

• Working conditions are normal for an office environment.

• Work may require weekend and evening work.

• Work may require travel.

• Physical activity includes sitting, walking, standing, bending, squatting, reaching above shoulders and lifting up to 40 pounds.

• Work under stress in a fast-paced environment.

• Must be alert, able to concentrate, and use good judgment.


Company Description

IMI specializes in tamper-evident technologies that help prevent drug diversion and misuse. Our solutions are essential to hospital and pharmacy drug security programs.