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Quality Manager Medical Device Jobs in Indiana (NOW HIRING)

Ambu

Quality Engineer

Noblesville, IN · On-site

$67K - $87K/yr

Quality Assurance Department: QA, Noblesville Employment Type: Full-time Req ID: 9887 We are seeking a Quality Engineer with experience in medical device design quality and risk management to support ...

BSI Group

Knowledge of medical device regulations ... Awareness of certification business processes, the application of quality management standards, and ...

New

BSI Prof Serv EHS West

Knowledge of medical device regulations ... Awareness of certification business processes, the application of quality management standards, and ...

New

Alfa Laval U.S. Holding Inc.

Quality Manager

Greenwood, IN · On-site

$110K - $130K/yr

About the job The Quality Manager develops and implements the corporate quality strategy, manages ... Alfa Laval offers a competitive salary and full benefits package, including medical/dental/vision ...

Roembke Mfg & Design Inc

Quality Technician

Ossian, IN · On-site

$16.50 - $22.25/hr

... medical device and industrial applications . RTS is a small, ISO 13485 and ISO 9001 certified ... Reporting to the Quality Manager , the Quality Technician is a mid-level position that plays a ...

BSI Group

Thorough knowledge of ISO 13485 quality standard and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) * Quality management experience including significant ...

BSI Prof Serv EHS West

Thorough knowledge of ISO 13485 quality standard and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) * Quality management experience including significant ...

Caterpillar

Quality Manager

Lafayette, IN · On-site

$89K - $133K/yr

The Quality Manager oversees the administration and continual improvement of quality management ... Medical, dental, and vision benefits* * Paid time off plan (Vacation, Holidays, Volunteer, etc ...

Lippert

Quality Manager

Goshen, IN · On-site

Comprehensive benefit offerings including medical, dental, vision, 401k with employer match ... The Quality Manager is responsible for overseeing and managing all aspects of quality assurance ...

Lippert

Quality Manager

Goshen, IN · On-site

Comprehensive benefit offerings including medical, dental, vision, 401k with employer match ... The Quality Manager is responsible for overseeing and managing all aspects of quality assurance ...

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Showing results 21-40

All JobsQuality Medical Device JobsQuality Manager Medical Device JobsQuality Manager Medical Device Jobs in Indiana

Quality Manager Medical Device information

See Indiana salary details

$22.8K

$82K

$150.3K

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

As of Aug 10, 2026, the average yearly pay for quality manager medical device in Indiana is $81,986.00, according to ZipRecruiter salary data. Most workers in this role earn between $41,900.00 and $129,400.00 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 Indiana? The most popular types of Quality Medical Device jobs in Indiana are:
What are popular job titles related to Quality Manager Medical Device jobs in Indiana? For Quality Manager Medical Device jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Quality Manager Medical Device jobs in Indiana look for? The top searched job categories for Quality Manager Medical Device jobs in Indiana are:
What cities in Indiana are hiring for Quality Manager Medical Device jobs? Cities in Indiana 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 Indiana as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution, with an average salary of $81,986 per year, or $39.4 per hour.

Medical Device Design Control Engineer

Prophecy Technologies

Indianapolis, IN • On-site

$123K - $148K/yr

Full-time

Posted 14 days ago

Job description

Role Overview:
This role involves supporting Design History File (DHF) activities and comprehensive risk management for medical device development projects. The engineer will be responsible for reviewing, updating, and maintaining critical documentation such as FMEAs, PHAs, Product Characterization, and Product Specifications, ensuring compliance with regulatory and quality standards throughout the product lifecycle.
Key Responsibilities:
  • Support Design History File (DHF) activities for medical device development projects.
  • Review, update, and maintain Global dFMEA documentation ensuring risks are adequately identified, analyzed, and mitigated.
  • Review, update, and maintain Global uFMEA documentation based on product use scenarios and user-related risks.
  • Develop and update Preliminary Hazard Analysis (PHA) documentation in accordance with risk management procedures.
  • Support creation and maintenance of product risk management files throughout the development lifecycle.
  • Prepare, review, and update Product Characterization documents to define product performance and design intent.
  • Create and maintain Product Specification Documents (PSD) ensuring alignment with design requirements and customer needs.
  • Develop and update Critical-to-Quality (CTQ) documents and establish measurable quality requirements.
  • Support development and maintenance of Design Input, Design Output, Verification, and Validation documentation.
  • Ensure traceability between user needs, design inputs, risk controls, verification activities, and design outputs.
  • Collaborate with Design, Quality, Regulatory, Manufacturing, and Project Management teams to support product development deliverables.
  • Participate in design reviews and provide technical input on risk management and DHF compliance.
  • Support engineering change assessments and associated documentation updates.
  • Review engineering documents for completeness, accuracy, and compliance with quality system requirements.
  • Identify gaps in documentation and recommend corrective actions.
  • Support audits, inspections, and compliance activities related to design control and risk management documentation.
  • Contribute to continuous improvement initiatives for product development and design control processes.
  • Ensure all deliverables comply with applicable regulatory, quality, and Zimmer Biomet procedures and standards.
  • Communicate (written and verbal) direction and project plans with appropriate personnel from other departments.

Required Skills:
  • Ability to establish document traceability between User Needs, Design Inputs, Design Outputs, Risk Management, Verification, and Validation records within Cockpit Cognition.
  • Experience supporting DHF gap assessments, document linking, metadata management, and compliance reviews.
  • Familiarity with digital DHF structure, document hierarchy, and traceability matrix development.
  • Knowledge of DHF remediation projects and legacy design documentation migration into Cockpit Cognition.

Qualifications:
  • Experience: N/A

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