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Quality Manager Medical Device Jobs in Delaware (NOW HIRING)

Hologic Inc.

Quality Inspector 2

Newark, DE · On-site

Awareness of FDA-regulated environments and medical device quality standards (preferred). Skills ... Experience with Oracle ERRP or Agile Lifecycle Management System is beneficial Education: * High ...

Hologic

Quality Inspector 2

Newark, DE · On-site

Awareness of FDA-regulated environments and medical device quality standards (preferred). Skills ... Experience with Oracle ERRP or Agile Lifecycle Management System is beneficial Education: * High ...

Hologic

Senior Software Design Assurance Engineer

Newark, DE · On-site

$97K - $152K/yr

... quality, safety, reliability, and regulatory compliance of medical device software throughout the ... Expertise in risk management per ISO 14971, including Hazard Analysis and FMEA. * Familiarity with ...

Katalyst CRO

Quality Assurance Engineer

Newark, DE · On-site

Katalyst CRO is looking for a QA Engineer with Life Sciences domain experience to support testing ... and medical device companies worldwide. Founded in , the company is headquartered in South ...

Hologic Inc.

Product Quality Engineer 2

Newark, DE · On-site

$78K - $122K/yr

Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14971 (Risk Management), GMP, and GDP. * Familiarity with ...

Hologic

Product Quality Engineer 2

Newark, DE · On-site

$78K - $122K/yr

Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14971 (Risk Management), GMP, and GDP. * Familiarity with ...

Datwyler

Quality Assurance Engineer

Middletown, DE · On-site

... medical device, pharmaceutical, or healthcare packaging . * Experience with molding or precision ... Risk management (ISO 14971) * Process validation * Experience with statistical tools and SPC.

Datwyler

Quality Assurance Engineer

Middletown, DE · On-site

... medical device, pharmaceutical, or healthcare packaging . * Experience with molding or precision ... Risk management (ISO 14971) * Process validation * Experience with statistical tools and SPC.

Hologic Inc.

Product Quality Engineer 3

Newark, DE

$85K - $133K/yr

Working knowledge of FDA Quality System Regulations, especially Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14970, Risk Management, GMP, and GDP * Ability to effectively ...

Hologic

Product Quality Engineer 3

Newark, DE · On-site

$85K - $133K/yr

Working knowledge of FDA Quality System Regulations, especially Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14970, Risk Management, GMP, and GDP * Ability to effectively ...

Hologic Inc.

Quality Assurance Technician 3

Newark, DE · On-site

$54K - $80K/yr

Experience working in a certified medical device environment is beneficial. * Experience with Agile ... Excellent organizational and time management skills * Knowledge of ISO 13485 and 17025 * Working ...

Hologic

Quality Assurance Technician 3

Newark, DE · On-site

$54K - $80K/yr

Experience working in a certified medical device environment is beneficial. * Experience with Agile ... Excellent organizational and time management skills * Knowledge of ISO 13485 and 17025 * Working ...

Hologic Inc.

Product Quality Engineer 1

Newark, DE · On-site

$54K - $86K/yr

Familiarity with FDA Quality System Regulations, especially Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14970, Risk Management, GMP, and GDP. * Ability to effectively ...

Hologic

Product Quality Engineer 1

Newark, DE · On-site

$54K - $86K/yr

Familiarity with FDA Quality System Regulations, especially Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14970, Risk Management, GMP, and GDP. * Ability to effectively ...

Hologic

Product Quality Engineer 2

Newark, DE · On-site

$78K - $122K/yr

Working knowledge of FDA Quality System Regulations, especially Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14970, Risk Management, GMP, and GDP * Ability to effectively ...

Hologic Inc.

Product Quality Engineer 2

Newark, DE · On-site

$78K - $122K/yr

Working knowledge of FDA Quality System Regulations, especially Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14970, Risk Management, GMP, and GDP * Ability to effectively ...

Hologic Inc.

Quality Design Engineer 2

Newark, DE · On-site

$78K - $122K/yr

... medical device process and/or product development environment. Skills Experience with FDA Quality Systems Regulation, especially Design Control requirements, ISO 13485, ISO 14971 (Risk Management ...

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Showing results 21-40

All JobsQuality Medical Device JobsQuality Manager Medical Device JobsQuality Manager Medical Device Jobs in Delaware

Quality Manager Medical Device information

See Delaware salary details

$24K

$86.2K

$158.1K

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

As of Aug 15, 2026, the average yearly pay for quality manager medical device in Delaware is $86,234.00, according to ZipRecruiter salary data. Most workers in this role earn between $44,000.00 and $136,100.00 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?

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 the most commonly searched types of Quality Medical Device jobs in Delaware?

The most popular types of Quality Medical Device jobs in Delaware are:

What are popular job titles related to Quality Manager Medical Device jobs in Delaware?

For Quality Manager Medical Device jobs in Delaware, the most frequently searched job titles are:

What job categories do people searching Quality Manager Medical Device jobs in Delaware look for?

The top searched job categories for Quality Manager Medical Device jobs in Delaware are:

What cities in Delaware are hiring for Quality Manager Medical Device jobs?

Cities in Delaware with the most Quality Manager Medical Device job openings:

Quality Manager Medical Device jobs near you
Infographic showing various Quality Manager Medical Device job openings in Delaware as of August 2026, with employment types broken down into 1% As Needed, 76% Full Time, 17% Part Time, and 6% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $86,234 per year, or $41.5 per hour.

Quality Inspector 2

Hologic Inc.

Newark, DE • On-site

Full-time

Posted 24 days ago

Hologic rating

8.0

Company rating: 8.0 out of 10

Based on 25 frontline employees who took The Breakroom Quiz

176th of 489 rated machine equipment manufacturers

Job description

Are you detail-oriented and passionate about delivering high-quality products? At Hologic, we are seeking a Quality Control Inspector to ensure our products meet the highest standards of quality and compliance. In this role, you'll perform inspections, testing, and sampling procedures for manufacturing processes, packaging lines. You'll play a key part in maintaining compliance with FDA compliance, supporting investigations, and driving continuous improvement initiatives. If you have a keen eye for detail, a commitment to excellence, and a desire to work in a collaborative environment, we'd love to hear from you!
 

Knowledge:
 

  • Familiarity with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
     
  • Basic understanding of quality control tools.
     
  • knowledge of controls for nonconforming product. 
     
  • Knowledge of process auditing, documentation, and record-keeping.
     
  • Ability to read and interpret operating procedures. 
     
  • Awareness of FDA-regulated environments and medical device quality standards (preferred).
     

Skills:
 

  • Proficient in Microsoft Office applications, including Excel, Word, SharePoint, and OneDrive.
     
  • Strong verbal and written communication skills for accurate documentation and collaboration.
     
  • High attention to detail and focus on quality assurance processes.
     
  • Ability to follow written procedures and maintain accurate, organized records.
     
  • Capable of working both independently and collaboratively as part of a team.
     
  • Analytical mindset for supporting non-conformance investigations and identifying process improvements.
     

Behaviors:
 

  • Safety-conscious, maintaining a safe work environment and promptly addressing hazards.
     
  • Proactive and dependable, with a strong sense of accountability for quality and timelines.
     
  • Collaborative and team-oriented, fostering positive working relationships.
     
  • Adaptable and eager to contribute to continuous improvement initiatives like Kaizen events.
     
  • Reliable and punctual, with a commitment to maintaining attendance and meeting deadlines.
     

Experience:
 

  • 2-4 years of experience in quality assurance or manufacturing roles, preferably in an FDA-regulated medical device environment.
     
  • Hands-on experience with quality control tools and techniques is beneficial.
     
  • Familiarity with clean rooms, controlled environments, and production processes is a plus.
     
  • Experience with Oracle ERRP or Agile Lifecycle Management System is beneficial
     

Education:
 

  • High School Diploma (H.S./GED) required; an Associate Degree is a plus.

Why join Hologic?
We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
The annualized base salary range for this role is $ 47,200 - $70,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
Agency and Third-Party Recruiter Notice
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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