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Supplier Quality Engineer Medical Device Jobs (NOW HIRING)

Supplier Quality Engineer

Colorado Springs, CO ยท 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 ...

Supplier Quality Engineer

Colorado Springs, CO ยท 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 ...

OrthAlign, Inc., a Smart Technology, growing medical device company, has an immediate opening for ... Maintain supplier quality records. You need: * Your BA/BS Engineering-oriented degree and 2+ years ...

... such as Supplier Quality Engineering, Design Engineering, Process Engineering, Continuous ... ISO 13485 medical device environment. Please include: Type of medical devices or components ...

The Senior Supplier Quality Engineer (Sr. SQE) is responsible for leading supplier quality ... Strong knowledge of ISO 13485 and medical device regulatory requirements * Experience with supplier ...

Conform to ISO13485, 21 CFR Part 820, and medical device industry requirements * Other work-related ... Strong knowledge of supplier quality management principles and quality engineering practices.

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Supplier Quality Engineer Medical Device information

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$58.5K

$111.5K

$130K

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

As of Sep 7, 2026, the average yearly pay for supplier quality engineer medical device in the United States is $111,474.00, according to ZipRecruiter salary data. Most workers in this role earn between $89,000.00 and $129,000.00 per year, depending on experience, location, and employer.

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

A Supplier Quality Engineer (SQE) in the medical device industry is responsible for ensuring that materials, components, and products supplied by external vendors meet the required quality standards and regulatory requirements. They work closely with suppliers to conduct audits, assess processes, and resolve quality issues to ensure the safety and efficacy of medical devices. SQEs also collaborate with internal teams to develop quality control plans, manage supplier performance, and support continuous improvement initiatives throughout the supply chain.

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

To excel as a Supplier Quality Engineer in the medical device field, you need a strong background in engineering, quality systems, and knowledge of regulatory standards like ISO 13485, often supported by a relevant degree. Familiarity with quality management systems (QMS), statistical analysis tools, and supplier auditing processes is critical, and certifications such as Six Sigma or ASQ CQE are highly valued. Strong analytical thinking, problem-solving, and effective communication skills help you collaborate with suppliers and internal teams to resolve quality issues. These competencies ensure supplier compliance, product safety, and ongoing regulatory adherence in a highly regulated industry.

How does a supplier quality engineer in the medical device industry typically collaborate with suppliers to ensure compliance with regulatory standards?

Supplier Quality Engineers in the medical device industry work closely with suppliers through regular audits, quality reviews, and ongoing communication to ensure that supplied components meet stringent regulatory standards such as ISO 13485 and FDA requirements. They often provide feedback, assist with corrective actions, and may help suppliers develop or improve their quality systems. Building strong, proactive relationships with suppliers is critical, as is the ability to interpret and apply regulatory requirements to real-world manufacturing processes. This collaborative approach helps mitigate risks and maintain product quality throughout the supply chain.

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

AspectSupplier Quality Engineer Medical DeviceQuality Engineer Medical Device
Primary FocusSupplier quality management, supplier audits, and incoming material inspectionOverall product quality, process improvements, and internal quality systems
Work EnvironmentSupplier facilities, manufacturing sites, and quality auditsInternal manufacturing, R&D, and quality departments
Certifications & CredentialsISO 13485, CQE, ASQ certifications often preferredISO 13485, CQE, Six Sigma certifications often preferred

While both roles focus on quality within the medical device industry, the Supplier Quality Engineer Medical Device primarily manages supplier quality and incoming materials, whereas the Quality Engineer Medical Device oversees overall product quality and internal processes. Understanding these distinctions helps candidates target the right roles based on their expertise and career goals.

How much does a supplier quality engineer medical device make in the US?

A supplier quality engineer in the medical device industry in the US typically earns between $70,000 and $110,000 annually, depending on experience, location, and certifications such as CQE or ASQ. Salaries can vary based on company size and specific responsibilities, with higher compensation often associated with advanced skills in quality management systems and regulatory compliance.
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Infographic showing various Supplier Quality Engineer Medical Device job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 92% Physical, 1% Hybrid, and 7% Remote job distribution, with an average salary of $111,474 per year, or $53.6 per hour.

Supplier Quality Engineer

Accord Technologies Inc.

Latham, NY โ€ข On-site

Contractor

Re-posted 17 days ago


Job description

Title: Supplier Quality Engineer
Location : Latham, NY
Domain: Medical Device industry.

 
Job Description
    • Implement Quality Engineering, Purchasing Controls, and Supplier Quality processes related to the development, procurement, and continuous improvement of manufacturing materials, components, software, sub-assemblies, contract manufactured finished devices, products, or services.
    • Evaluate suppliers' critical quality processes and ensure compliance with regulatory requirements and procedures.
    • Drive supplier improvement via SQIPs (Supplier Quality Improvement Plans) and lead the Supplier Change Notice process with support from Engineering, Quality Engineering, Assurance,
    • Qualify suppliers, assess their metrics, and audit their critical quality processes.
    •  Ensure validations are completed where specified and control plans exist to ensure sustained quality and compliance of supplied raw materials and components.
    •  Independently Produces and completes Supplier Quality Engineering related activities and documentation.
    • Completes Qualification of materials and components (including spare parts), development/ improvement of supplier processes for CtQ's, supplier process control plans; ensuring that the supplied part meets specifications, and the control limits/tolerances for CtQ parameters are met.
    • Qualifies and sustains sub- processes of suppliers, including performing process validations for critical supplier processes impacting part quality.
    • Ensures that the components/products at the supplier (including spare parts and services) are released according agreed specification and quality requirements (APQP / PPAP), and SQ audit results.
    •  Executes SCAR management, effective and timely closure Regulatory, ME, R&D, Clinical, etc.
    • Experience in leading process improvement methodologies and organizational change management.
    • Proven record of accomplishment in developing suppliers and implementing lean methodologies at supplier end.
    • Develop and support regulatory compliance gaps at suppliers, including supplier quality system and process development activities.
    • Manage additions/deletions/changes to the status of suppliers on the Approved Supplier List, including supplier master file records
    • Ensure raw materials/components/products at supplier(s) are released from supplier(s) according to the agreed requirements.
    • Perform 3rd party product compatibility risk assessments in partnership with R&D and Market Procurement (Markets SQE).
    • Drive quality and compliance development and/or improvement at suppliers when needed.
Required Skills and Qualifications:
 
    • Bachelor’s degree in engineering or science discipline, or equivalent experience.
    • A minimum of 4 to 8 years of experience in establishing and maintaining regulated supplier management systems.
    • Engineer quality and ensure compliance for raw materials, components, finished products etc.
    • Certification with a recognized Accreditation body (i.e., RAB-QSA/IRCA) or successful completion of ASQ certification as a Certified Quality Engineer(CQE) and Certified Quality will be advantage.
    •  Any Auditor (CQA) or Certified Biomedical Auditor or successful completion of a recognized Lead Auditor course will be added advantage.
    • Excellent communication skills in English (written and verbal).
    • Demonstrated experience in collaborative working environments, conflict resolution, and stakeholder influencing.
    • Ability to drive progress, take initiative, and achieve results.
    • Experience with technical drawings, specifications of parts.
    • Experience in Manufacturing process of welding, soldering, crimping, injection molding, plating, casting, and thermal forming
    • Experience with APQP (IQ,OQ,PQ) preferred.
    • Technical writing of protocols and reports.
    •  Experience in ISO 9001, 13485 a plus.
    • Ability to travel to supplier sites within assigned region.
    • Looking for candidate who has extensive medical device domain industry experience.