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Senior Quality Engineer Medical Device Jobs in Indiana

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Machinist / Inspector - Medical Device Manufacturing Company Overview Flotec is an Indianapolis ... Work with production, quality, and engineering personnel to resolve machining or inspection issues.

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 ...

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 ...

Summary The Quality Assurance Engineer will support the organization towards compliance of ... Ensure compliance with FDA, ISO 13485, and other relevant regulatory standards for medical device ...

Quality Engineer

Warsaw, IN · On-site

$69K - $89K/yr

CQE). o Certified Quality Engineer (CQE) and Medical device, particularly Orthopedic industry, experience preferred. o Bachelors degree in sciences, health care certificates, mechanical or biologic ...

Collaborate with internal Quality and Engineering teams to determine appropriate validation ... Conform to ISO13485, 21 CFR Part 820, and medical device industry requirements * Other work-related ...

Quality Engineer II

Warsaw, IN · On-site

$35 - $40/hr

Certified Quality Engineer (CQE) and Medical device, particularly Orthopedic industry, experience preferred Position Type/Expected Hours of Work: This is a full-time position with typical business ...

Quality Engineer III

Spencer, IN · On-site

$61K - $80K/yr

Experience in the medical device industry * Self-starter with the ability to identify improvement ... supplier quality and process engineering functions. * Proficiency with Microsoft Office ...

Showing results 41-60

Senior Quality Engineer Medical Device information

What is a senior quality engineer medical device?

Senior Quality Engineers in the medical device industry are professionals responsible for ensuring that medical devices meet regulatory standards and quality requirements throughout their lifecycle. They lead quality assurance activities, develop and implement testing protocols, coordinate with design and manufacturing teams, and help ensure compliance with relevant regulations such as FDA and ISO standards. Their expertise ensures that products are safe, effective, and reliable for patient use. They also mentor junior engineers and may play a key role in audits and process improvements.

How does a senior quality engineer medical device typically collaborate with cross-functional teams during product development?

As a Senior Quality Engineer in the medical device sector, you will work closely with cross-functional teams including R&D, manufacturing, regulatory affairs, and supply chain. Your role involves ensuring quality standards are integrated throughout the product lifecycle, from design reviews and risk assessments to process validation and compliance documentation. Regular meetings, joint problem-solving sessions, and clear communication are vital to resolve issues efficiently and maintain regulatory compliance. This collaborative environment helps to ensure both product safety and timely market release.

What are the key skills and qualifications needed to thrive as a senior quality engineer medical device, and why are they important?

To excel as a Senior Quality Engineer in Medical Devices, you need a solid background in engineering, quality assurance, and regulatory compliance, typically with a relevant degree and experience in the medical device industry. Familiarity with ISO 13485, FDA 21 CFR Part 820, risk management tools (such as FMEA), and quality management systems is crucial, and certifications like CQE or Six Sigma are often preferred. Strong problem-solving, attention to detail, and effective communication skills distinguish top performers in this role. These competencies ensure product safety, regulatory compliance, and the continuous improvement of processes critical to patient outcomes and company success.

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

AspectSenior Quality Engineer Medical DeviceQuality Engineer Medical Device
ResponsibilitiesLead quality initiatives, oversee audits, mentor team membersAssist in quality processes, support audits, perform inspections
Experience & CertificationsTypically 5+ years, often ISO 13485, FDA regulationsEntry to mid-level, basic knowledge of industry standards
Work EnvironmentLeadership roles, cross-functional teams, strategic planningOperational tasks, documentation, compliance support
Usage & IndustryCommonly used in manufacturing, R&D, and quality departmentsUsed across similar settings, often as a stepping stone role

The main difference between a Senior Quality Engineer Medical Device and a Quality Engineer Medical Device lies in experience, responsibilities, and leadership scope. Senior roles involve strategic oversight and mentorship, while standard Quality Engineers focus on supporting quality processes and compliance tasks.

What are the most commonly searched types of Quality Engineer Medical Device jobs in Indiana?

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

What are popular job titles related to Senior Quality Engineer Medical Device jobs in Indiana?

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

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

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

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

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

Infographic showing various Senior Quality Engineer Medical Device job openings in Indiana as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 16% Part Time, and 6% Contract. Highlights an 92% Physical, 1% Hybrid, and 7% Remote job distribution.

Machinist / Inspector - Medical Device Manufacturing

Flotec

Avon, IN • On-site

$40K - $55K/yr

Full-time

Medical, Dental, Vision

Re-posted 27 days ago

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Job description

Machinist / Inspector – Medical Device Manufacturing

Company Overview

Flotec is an Indianapolis-based medical device manufacturer specializing in respiratory and oxygen delivery equipment. We manufacture precision medical products including oxygen regulators, flowmeters, fittings, valves, and related components used by hospitals, EMS providers, fire departments, military organizations, and medical device OEMs.

We are seeking a skilled and detail-oriented Machinist / Inspector to join our manufacturing team. This position supports both precision machining and inspection activities in a regulated medical device environment.

Position Summary

The Machinist / Inspector will be responsible for producing, inspecting, and verifying precision machined components used in medical device manufacturing. This role involves working with CNC machines, CNC Swiss machines, CNC mills, and mills with robotic automation.

The ideal candidate will have strong machining knowledge, excellent attention to detail, and the ability to inspect parts accurately using measuring instruments, drawings, specifications, and quality requirements. 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.

Key Responsibilities

  • Set up, operate, and monitor CNC machines, CNC Swiss machines, CNC mills, and robotic milling systems.
  • Inspect machined components to ensure compliance with engineering drawings, tolerances, specifications, and quality standards.
  • Use precision measuring equipment such as micrometers, calipers, thread gauges, plug gauges, pin gauges, height gauges, indicators, comparators, and other inspection tools.
  • Perform first-piece, in-process, and final inspections.
  • Read and interpret engineering drawings, work instructions, inspection plans, routings, and manufacturing documentation.
  • Verify dimensional accuracy, surface finish, threads, features, and critical characteristics.
  • Document inspection results accurately and completely.
  • Identify and report nonconforming parts, tooling issues, machine issues, or process concerns.
  • Make machine offsets and basic adjustments as needed to maintain part quality.
  • Work with production, quality, and engineering personnel to resolve machining or inspection issues.
  • Maintain clean, organized, and safe work areas.
  • Follow company procedures, quality system requirements, and medical device manufacturing standards.
  • Support continuous improvement efforts related to quality, productivity, setup reduction, and scrap reduction.
  • Assist with maintaining traceability and proper documentation for regulated medical device production.

Required Qualifications

  • Prior experience as a CNC machinist, CNC Swiss machinist, machine operator, inspector, or machinist/inspector.
  • Ability to read and understand engineering drawings and dimensional tolerances.
  • Experience using precision measuring instruments.
  • Strong attention to detail and commitment to quality.
  • Ability to work in a manufacturing environment and follow documented procedures.
  • Basic math skills, including decimals, fractions, and measurement conversions.
  • Ability to document work accurately and communicate issues clearly.
  • Dependable attendance and a strong work ethic.
  • Willingness to work in a regulated medical device manufacturing environment.

Preferred Qualifications

  • Experience with CNC Swiss machines.
  • Experience with CNC mills, lathes, or mills with robotic automation.
  • Experience inspecting small precision machined components.
  • Experience in medical device, aerospace, defense, automotive, or other regulated manufacturing industries.
  • Familiarity with ISO 13485, FDA-regulated manufacturing, or quality system documentation.
  • Experience with first article inspection, in-process inspection, final inspection, and nonconforming material processes.
  • Experience with oxygen equipment, brass, aluminum, stainless steel, or precision valve and regulator components.
  • Ability to perform basic machine setup, tooling changes, offsets, and troubleshooting.

Ideal Candidate

The ideal candidate is a hands-on machinist who also understands inspection and quality requirements. This person should be comfortable working around CNC equipment, checking their own work, identifying problems early, and helping ensure that every part meets the required specifications before moving to the next operation.

This position is well suited for someone who takes pride in precision work, enjoys manufacturing high-quality components, and wants to be part of a company producing products used in critical medical and emergency response applications.

Compensation and Benefits

Flotec offers competitive compensation based on experience and qualifications. Benefits may include paid time off, paid holidays, health insurance options, retirement plan participation, and opportunities for professional growth.

Schedule

Full-time position. Day shift. On-site position in Indianapolis, Indiana.

Work Location

Indianapolis, Indiana

Equal Opportunity Employer

Flotec is an Equal Opportunity Employer. We consider qualified applicants without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other legally protected status.

How to Apply

Qualified candidates are encouraged to submit a resume or work history outlining their CNC machining, Swiss machining, inspection, and manufacturing experience.

Company Description

Flotec is a Medical Device manufacturing company that makes Respiratory Equipment. Flotec is located off Rockville Rd east of Avon.

Flotec is an “Essential Business” as per Indiana Executive Order 20-08. Flotec is classified as a “Healthcare & Public Health Operation” and is EXEMPT from the Stay at Home Order.