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Quality Director Medical Device Jobs in Indiana (NOW HIRING)

VOLT

Medical Device Assembler

Westfield, IN · On-site

$20 - $23/hr

Follow standard operating procedures (SOPs) to ensure compliance with FDA, GMP, and quality system ... Prior experience as a Medical Device Assembler or Production Assembler is required * Ability to ...

VOLT

Medical Device Assembler

Carmel, IN · On-site

$20 - $23/hr

Follow standard operating procedures (SOPs) to ensure compliance with FDA, GMP, and quality system ... Prior experience as a Medical Device Assembler or Production Assembler is required * Ability to ...

Hearst

Medical Device Coder

Carmel, IN · On-site

$17.75 - $23.75/hr

First Databank (FDB) is currently seeking a Medical Device in the Quality department. This position is responsible for researching data published from the FDA, device manufactures, and other credible ...

Hearst Communications, Inc.

Medical Device Coder

Carmel, IN · On-site

$17.75 - $23.75/hr

First Databank (FDB) is currently seeking a Medical Device in the Quality department. This position is responsible for researching data published from the FDA, device manufactures, and other credible ...

Hearst Health

Medical Device Coder

Carmel, IN · On-site

$17.75 - $23.75/hr

First Databank (FDB) is currently seeking a Medical Device in the Quality department. This position is responsible for researching data published from the FDA, device manufactures, and other credible ...

Hearst

Medical Device Coder

Carmel, IN · On-site

$17.75 - $23.75/hr

Are you ready for this exciting challenge? _____ First Databank (FDB) is currently seeking a Medical Device in the Quality department. This position is responsible for researching data published from ...

Hearst

Medical Device Coder

Carmel, IN

$17.75 - $23.75/hr

Are you ready for this exciting challenge? _____ First Databank (FDB) is currently seeking a Medical Device in the Quality department. This position is responsible for researching data published from ...

Hearst

Medical Device Coder

Carmel, IN

$17.75 - $23.75/hr

Are you ready for this exciting challenge? _____ First Databank (FDB) is currently seeking a Medical Device in the Quality department. This position is responsible for researching data published from ...

Hearst Newspapers

Medical Device Coder

Indianapolis, IN · On-site

$18 - $24/hr

Are you ready for this exciting challenge? _____ First Databank (FDB) is currently seeking a Medical Device in the Quality department. This position is responsible for researching data published from ...

First Databank

Medical Device Coder

Carmel, IN · On-site

$17.75 - $23.75/hr

Are you ready for this exciting challenge? _____ First Databank (FDB) is currently seeking a Medical Device in the Quality department. This position is responsible for researching data published from ...

Flotec

Be Seen First

Machinist / Inspector - Medical Device Manufacturing

Avon, IN · On-site

$40K - $55K/yr

This is a hands-on position for someone who takes pride in producing high-quality parts and understands the importance of precision, documentation, and consistency in medical device manufacturing.

JobRx, Inc.

Director of Quality

Greenfield, IN · On-site

$170 - $210/hr

Ensure site adherence to GMP, ISO 13485, FDA, EMA, and other applicable regulations for medical device, drug packaging and combination products. * Direct Quality Assurance, Quality Engineering ...

RXinsider LTD.

Director of Quality

Greenfield, IN · On-site

$140 - $200/hr

Ensure site adherence to GMP, ISO 13485, FDA, EMA, and other applicable regulations for medical device, drug packaging and combination products. * Direct Quality Assurance, Quality Engineering ...

Posted today

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Quality Director Medical Device information

What does a quality director do in the medical device industry?

A Quality Director in the medical device industry is responsible for overseeing the development, implementation, and maintenance of quality management systems to ensure products meet regulatory and industry standards. They lead quality assurance teams, manage compliance with FDA and international regulations, and drive continuous improvement initiatives. Their work helps guarantee that medical devices are safe, effective, and reliable for patients and healthcare providers.

What are the key skills and qualifications needed to thrive as a quality director in the medical device industry?

To thrive as a Quality Director in the Medical Device industry, you need deep expertise in quality management systems (such as ISO 13485), regulatory compliance (FDA, EU MDR), and a background in engineering or life sciences. Familiarity with risk management tools, CAPA systems, and regulatory submission processes, along with certifications like ASQ CQE or Six Sigma, is highly valued. Strong leadership, problem-solving, and communication skills are essential for managing teams and fostering a culture of quality. These skills and qualifications are crucial to ensuring product safety, regulatory approval, and continuous improvement within highly regulated environments.

What are some common challenges a quality director faces in the medical device industry, and how can they be addressed?

A Quality Director in the medical device industry often encounters challenges such as navigating complex regulatory requirements, maintaining compliance across global markets, and ensuring consistent product quality during rapid growth or innovation. Proactive communication with cross-functional teams, continuous training on evolving standards like ISO 13485 and FDA regulations, and implementing robust quality management systems are key strategies to address these challenges. Building a culture of quality and fostering close collaboration between departments like R&D, manufacturing, and regulatory affairs are also essential for success in this role.

What is the role of a Quality Director Medical Device?

A Quality Director in the medical device industry oversees the development and implementation of quality management systems to ensure products meet regulatory standards and safety requirements. They lead quality assurance teams, conduct audits, and collaborate with regulatory bodies, often requiring knowledge of ISO 13485 and FDA regulations. Their role is critical in maintaining product compliance and continuous improvement processes.

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 Director Medical Device jobs in Indiana?

For Quality Director Medical Device jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Quality Director Medical Device jobs in Indiana look for?

The top searched job categories for Quality Director Medical Device jobs in Indiana are:

What cities in Indiana are hiring for Quality Director Medical Device jobs?

Cities in Indiana with the most Quality Director Medical Device job openings:

Quality Director Medical Device jobs near you

Medical Device DHF Engineer

Prophecy Technologies

Indianapolis, IN • On-site

Full-time

Posted 26 days ago

Job description

Role Overview:
This role focuses on supporting Design History File (DHF) activities and comprehensive risk management for medical device development projects. The specialist will be responsible for reviewing, updating, and maintaining critical documentation such as dFMEA, uFMEA, and Preliminary Hazard Analysis (PHA), ensuring compliance with regulatory and quality standards throughout the product lifecycle.
Key Responsibilities:
  • Support and manage Design History File (DHF) activities for medical device projects.
  • Review, update, and maintain Global dFMEA and uFMEA documentation, identifying and mitigating risks.
  • Develop and update Preliminary Hazard Analysis (PHA) in line with risk management procedures.
  • Support the creation and maintenance of product risk management files throughout the development lifecycle.
  • Prepare, review, and update Product Characterization documents, Product Specification Documents (PSD), and Critical-to-Quality (CTQ) documents.
  • Support the development and maintenance of Design Input, Design Output, Verification, and Validation documentation.
  • Ensure robust traceability between user needs, design inputs, risk controls, verification activities, and design outputs.
  • Collaborate cross-functionally with Design, Quality, Regulatory, Manufacturing, and Project Management teams.
  • Participate in design reviews, providing 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 documentation gaps 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.

Required Skills:
  • Ability to establish document traceability between User Needs, Design Inputs, Design Outputs, Risk Management, Verification, and Validation records within Cockpit Cognition.
  • Experience in 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.
  • Strong written and verbal communication skills for project plans and inter-departmental collaboration.

Qualifications:
  • Experience in medical device development environments, particularly with Design History File (DHF) and risk management processes.

Apply