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Contract Quality Engineer Medical Device Jobs in Colorado

LivaNova PLC

Quality Engineer

Arvada, CO · On-site

$85 - $95/hr

... medical device manufacturing and distribution. The role evaluates non‑conforming products ... Support Quality Management for executing quality engineering activities related to design and ...

LivaNova

Quality Engineer

Arvada, CO · On-site

$85K - $95K/yr

The Quality Engineer will contribute to ensure that production and process control activities are ... Experience with MDSAP and Medical Device Requirements is a plus Must have proficiency with quality ...

Philips

Supplier Quality Engineer

Colorado Springs, CO · On-site

$63K - $100K/yr

Job TitleSupplier Quality Engineer The Supplier Quality Engineer supports supplier qualification ... You have knowledge of medical device regulations, QMS requirements, and standards, such as 21 CFR ...

LivaNova, PLC

Quality Engineer

Arvada, CO · On-site

$85K - $95K/yr

The Quality Engineer will contribute to ensure that production and process control activities are ... medical device manufacturing and distribution. Evaluates situations of non-conforming products ...

Philips

Supplier Quality Engineer

Colorado Springs, CO · On-site

$63K - $100K/yr

Job Title Supplier Quality Engineer The Supplier Quality Engineer supports supplier qualification ... You have knowledge of medical device regulations, QMS requirements, and standards, such as 21 CFR ...

LivaNova, PLC

Medical Device Assembler

Arvada, CO · On-site

$19.50 - $21/hr

Medical Device Production Assembler Build Products That Help Change Lives Arvada, CO | Full-Time ... Collaborate closely with engineering, quality, and operations teams. * Take ownership of your work ...

LivaNova

Medical Device Assembler

Arvada, CO · On-site

$19.50 - $21/hr

Medical Device Production Assembler Build Products That Help Change Lives Arvada, CO | Full-Time ... Collaborate closely with engineering, quality, and operations teams. * Take ownership of your work ...

LivaNova PLC

Quality Engineer (On-site)

Arvada, CO · On-site

$67.50 - $82.50/hr

... medical device manufacturing and distribution. He/she evaluates situations of non‑conforming products, collects and analyzes data to propose product disposition and CAPA's to address quality issues.

LivaNova

Quality Engineer (On-site)

Denver, CO · On-site

$74K - $95K/yr

The Quality Engineer will contribute to ensure that production and process control activities are ... medical device manufacturing and distribution. He/she evaluates situations of non-conforming ...

LivaNova, PLC

Quality Engineer (On-site)

Denver, CO · On-site

$74K - $95K/yr

The Quality Engineer will contribute to ensure that production and process control activities are ... medical device manufacturing and distribution. He/she evaluates situations of non-conforming ...

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All JobsContract Quality Engineer Medical Device JobsContract Quality Engineer Medical Device Jobs in Colorado

Contract Quality Engineer Medical Device information

What does a contract quality engineer do in the medical device industry?

A Contract Quality Engineer in the medical device industry is responsible for ensuring that products meet regulatory and company quality standards during a specific project or timeframe. They typically work on a contract basis, focusing on tasks like process validation, risk management, root cause analysis, and compliance with standards such as ISO 13485 and FDA regulations. Their role often involves collaborating with engineering, production, and regulatory teams to troubleshoot quality issues and implement corrective actions. They play a key role in maintaining product safety and regulatory compliance throughout the manufacturing process.

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

To thrive as a Contract Quality Engineer in the Medical Device field, you need expertise in quality assurance, regulatory compliance (such as ISO 13485 and FDA regulations), and a background in engineering or life sciences. Familiarity with tools like CAPA systems, risk management software, and proficiency in quality management systems (QMS) is typically required. Strong analytical thinking, attention to detail, and effective communication skills set top performers apart in this role. These skills are essential to ensure product safety, regulatory compliance, and the successful launch and maintenance of medical devices in a highly regulated environment.

How does a contract quality engineer in the medical device industry typically collaborate with cross-functional teams?

As a Contract Quality Engineer in the medical device sector, you will frequently work closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and supply chain. Your responsibilities often involve reviewing design documentation, participating in risk assessments, and ensuring production processes meet both internal quality standards and regulatory requirements. Effective communication is key, as you'll be responsible for conveying quality expectations, addressing non-conformities, and supporting project timelines. This collaborative environment provides valuable experience in coordinating with diverse professionals while upholding strict industry standards.

What is the difference between Contract Quality Engineer Medical Device vs Contract Quality Engineer Pharmaceutical?

AspectContract Quality Engineer Medical DeviceContract Quality Engineer Pharmaceutical
CertificationsISO 13485, FDA QSR, GMPICH Q7, GMP, FDA regulations
Work EnvironmentMedical device manufacturing, labs, compliance auditsPharmaceutical production, labs, quality assurance
Industry UsageMedical device companies, OEMs, suppliersPharmaceutical firms, biotech companies, contract manufacturers

Both roles focus on quality assurance and regulatory compliance but differ mainly in industry-specific standards and environments. Contract Quality Engineers Medical Device work primarily with ISO 13485 and FDA QSR standards in device manufacturing, while Contract Quality Engineers Pharmaceutical focus on GMP and ICH Q7 regulations in drug production. Understanding these differences helps candidates target the right industry and certifications for their career goals.

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

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

What are popular job titles related to Contract Quality Engineer Medical Device jobs in Colorado?

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

What job categories do people searching Contract Quality Engineer Medical Device jobs in Colorado look for?

The top searched job categories for Contract Quality Engineer Medical Device jobs in Colorado are:

What cities in Colorado are hiring for Contract Quality Engineer Medical Device jobs?

Cities in Colorado with the most Contract Quality Engineer Medical Device job openings:

Contract Quality Engineer Medical Device jobs near you

Quality Engineer

LivaNova PLC

Arvada, CO • On-site

$85 - $95/hr

Other

Re-posted 3 days ago

Job description

Position Summary

With a high degree of autonomy, the Quality Engineer will contribute to ensuring that production and process control activities are conducted in compliance with the company quality management system and the international regulations governing medical device manufacturing and distribution. The role evaluates non‑conforming products, analyzes data, proposes product disposition, initiates CAPAs, and communicates findings to manufacturers or develops process improvements.

Responsibilities
  • Support Quality Management for executing quality engineering activities related to design and manufacture of products in compliance with the Quality Management System requirements and applicable regulations.
  • Collect and critically analyze data and take disposition decisions on non‑conforming products identified in production.
  • Lead proper investigations to identify causes of component/product failures (nonconforming products from production and complaints).
  • Generate risk evaluations for nonconforming products already distributed (Health Hazard Evaluation) to assist management in determining whether to stop shipment or initiate field action.
  • Lead CAPA projects and trend data to identify opportunities for future CAPAs.
  • Support external manufacturers of semi‑finished and finished products in managing any detected nonconformities, notifying suppliers of non‑conformance related to purchased material, and evaluating corrective action consistency versus internal controls.
  • Establish product quality control inspection plans, review process validation planning, protocols, and reports.
  • Preliminary review of change impact assessment to confirm quality requirements are met.
  • Maintain Risk Management files and collaborate in investigations into the causes of V&V failures.
  • Identify opportunities for quality improvements in the production area and lead improvement plans.
  • Daily management of assigned complaint handling activities related to customer use of the device, evaluating and investigating complaints, and providing timely analysis to meet Customer Quality complaint and MDR reporting quality metrics.
  • Lead effective meetings, conduct presentations, and establish quality records to support resolution of customer complaints.
  • Develop effective relationships with internal personnel and external stakeholders to assist customers.
Qualifications
  • 1‑3 years of related experience in Class II/III medical device manufacturing or related regulatory industry.
  • Knowledge of regulatory requirements (e.g., FDA, ISO13485).
  • Experience with MDSAP and Medical Device Requirements is a plus.
  • Proficiency with quality tools such as flowcharts, statistical data analysis, and mathematical reasoning.
  • Experience with CAPA and ability to analyze and problem‑solve.
  • Ability to work within a changing environment and engage a wide variety of personnel on all levels.
  • ASQ Certified Quality Engineer or other ASQ certifications are a plus.
  • Excellent written and verbal communication and presentation skills.
  • Ability to communicate across functional lines.
Physical Demands and Work Conditions
  • Sitting 60‑80%, standing & walking 20‑40%.
  • Repetitive work on computer 80%.
  • Must be able to work in a clean room environment and tolerate chemical odors.
  • Must be able to work in a lab environment and tolerate the smell and sight of blood.
Education

Bachelor’s Degree in Technical and Scientific disciplines (Engineering, Physics, Chemistry, or Biology).

Benefits and Compensation

Salary range: $85,000–$95,000 annually + annual bonus incentive.

Travel Requirements: Occasional travel may be required.

Equal Employment Opportunity

LivaNova values equality and diversity. The company is committed to ensuring that the recruitment process is fair, transparent, and free from unlawful discrimination. Selection is based on key demands/requirements for the role rather than bias or discrimination on the basis of legally protected classifications.

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