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Contract Quality Engineer Medical Device Jobs (NOW HIRING)

Medical Device Quality Engineer Position Type :Contract Projected Start Date :08-09-2017 Zip Code :33716 City :St. Petersburg State :FL Required Skills : ISO 9000 Not looking for a Design or testing ...

Validation / Operations Quality Engineer - Medical Devices Help bring life-changing medical ... Experience in a startup or small medical device company. * Hands-on experience with process ...

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Contract Quality Engineer Medical Device information

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$119K

How much do contract quality engineer medical device jobs pay per year?

As of Jul 14, 2026, the average yearly pay for contract quality engineer medical device in the United States is $84,039.00, according to ZipRecruiter salary data. Most workers in this role earn between $72,000.00 and $93,000.00 per year, depending on experience, location, and employer.

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 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, and why are they important?

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.
More about Contract Quality Engineer Medical Device jobs
What cities are hiring for Contract Quality Engineer Medical Device jobs? Cities with the most Contract Quality Engineer Medical Device job openings:
What are the most commonly searched types of Quality Engineer Medical Device jobs? The most popular types of Quality Engineer Medical Device jobs are:
What states have the most Contract Quality Engineer Medical Device jobs? States with the most job openings for Contract Quality Engineer Medical Device jobs include:
Infographic showing various Contract Quality Engineer Medical Device job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 62% Full Time, 19% Part Time, 1% Temporary, and 17% Contract. Highlights an 80% Physical, 2% Hybrid, and 18% Remote job distribution, with an average salary of $84,039 per year, or $40.4 per hour.
Supplier Quality Engineer -Medical device

Supplier Quality Engineer -Medical device

APN Software Services, Inc

Bothell, WA โ€ข On-site

Other

Posted 6 days ago

New


Job description

Position Title: Supplier Quality Engineer (PHIAJP00004048)        

Location: Bothell Washington USA 98021 

Duration: 11 months

Positions Requested: 1

Hours per Week: 40 (8 hrs/day)

Job Title: Supplier Quality Engineer

Job Responsibilities:

  • Facilitates technical capability assessments of potential new suppliers, ensuring they meet the company''s quality standards, and contributes to the supplier selection.
  • Conducts and reviews DFMAT (Design for Manufacturing and Assembly Technique), SAF (Supplier Approval Form), MSA (Measurement System Analysis), PFMEA (Process Failure Mode and Effects Analysis), Control Plan, SPC (Statistical Process Control), PV&V (Process Validation and Verification), FAI (First Article Inspection), LRA (Logistics Risk Assessment), and SICR (Supplier Initiated Change Request).
  • Develops, executes, monitors, and controls APQP (Advanced Product Quality Planning) plans as part of the NPI process to ensure consistent product quality.
  • Contributes to the content of the Supplier Project Book, documenting detailed quality requirements and expectations for suppliers.
  • Facilitates collaboration between R&D and suppliers in Design for Excellence (DfX) initiatives to enhance product design quality and innovation.
  • Focuses that Critical to Quality (CtQ) characteristics are effectively communicated to suppliers and rigorously maintained throughout the production process.
  • Coordinates Part Submission Warrant plans, deliverables, line releases, and completion, ensuring all parts meet specified quality standards before approval.
  • Executes supplier improvement and development initiatives on APQP (Advanced Product Quality Planning), providing guidance and resources to enhance supplier processes, ensuring they meet the high standards required for production quality and efficiency.
  • Assists with the process of making additions, changes, or deletions to the Approved Supplier List, ensuring that only qualified suppliers are retained.
  • Supports in end-to-end performance management of suppliers, conducts detailed analysis of defects to determine if they are supplier-caused, and acts as an independent reviewer for Supplier Corrective Action Requests.

Requirements:

  • Minimum required Education: Bachelor''s / Master''s Degree in Engineering Science, Supply Chain Management, Electrical Engineering, Electronic Engineering or equivalent.
  • Minimum required Experience: Minimum 8 years of experience with a Bachelor''s in areas such as Quality Engineering, Safety Engineering, Process Engineering, Continuous Improvement Techniques or equivalent.
  • Minimum required Certification: N/A
  • Preferred Education: Master''s degree in Engineering.
  • Preferred Experience: 8 years of experience.
  • Preferred Certification: LEAN Six Sigma.

Preferred Skills:

  • Supplier Quality Management
  • Quality Management Procedures and Methodologies
  • Supplier Evaluation Methodologies
  • Data Analysis & Interpretation
  • DfX Methodology
  • Supply Chain Management (SCM)
  • Quality Specifications
  • CAPA Methodologies
  • Statistical Process Control (SPC)
  • Measurement Systems Analysis (MSA)
  • Process Validation and Verification (PV&V)
  • First Article Inspections
  • Documentation & Reporting
  • Regulatory Requirements
  • Continuous Improvement

Thanks, 

Amit Sehdev

APN Software Services Inc.

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