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Quality Engineer Medical Device Jobs in Rochester, NY

Bausch + Lomb

Medical Device Engineer I

Rochester, NY · On-site

$65K - $100K/yr

The Medical Device Engineer II supports the design and development of contact lenses within Bausch + Lomb's Vision Care R&D organization. This role serves as a product advocate on cross-functional ...

Cooper Companies

Quality Engineer

West Henrietta, NY · On-site

$69K - $92K/yr

... with medical device distribution and packaging operations. Education: * Bachelor's degree (B.S ... Certified Quality Engineer, Green Belt or Lean certified preferred. We are committed to equal ...

Bausch + Lomb

Quality Engineer III

Rochester, NY · On-site

$95K - $128K/yr

Minimum 10 years of relevant experience in Quality or Engineering in a medical device or regulated industry Strong working knowledge of: * ISO 13485 * FDA 21 CFR Part 820 * Risk Management (ISO 14971 ...

PEKO Precision Products

Quality Engineer

Rochester, NY · On-site

$60K - $89K/yr

... medical, industrial, defense, and renewable energy industries. Enriching life is a crucial ... Device Master Records (DMR). * Knowledge of ISO 13485 and AS9100; ability to establish quality ...

Https://www.sydor.com/

Quality Engineer

Rochester, NY · On-site

$71K - $91K/yr

... medical, entertainment, and more. At Sydor, your work matters. You'll collaborate with talented ... Quality Engineer Reports To: Director of Quality & Operational Excellence Status: Full-Time FLSA ...

Sydor Optics Inc.

Quality Engineer

Rochester, NY · On-site

$75K - $88K/yr

... medical, entertainment, and more. At Sydor, your work matters. You'll collaborate with talented ... Quality Engineer Reports To: Director of Quality & Operational Excellence Status: Full-Time FLSA ...

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All JobsQuality Engineer Medical Device JobsQuality Engineer Medical Device Jobs in Rochester, NY

Quality Engineer Medical Device information

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How much do quality engineer medical device jobs pay per hour?

As of Jul 16, 2026, the average hourly pay for quality engineer medical device in Rochester, NY is $36.23, according to ZipRecruiter salary data. Most workers in this role earn between $24.42 and $45.29 per hour, depending on experience, location, and employer.

What does a Quality Engineer do in the medical device industry?

A Quality Engineer in the medical device industry is responsible for ensuring that medical devices meet all regulatory standards and quality requirements. They develop and implement quality assurance processes, perform risk assessments, and conduct inspections and audits to make sure products are safe and effective. Quality Engineers also collaborate with design, manufacturing, and regulatory teams to resolve quality issues and improve product reliability. Their work is crucial for maintaining compliance with standards such as ISO 13485 and FDA regulations.

What is the difference between Quality Engineer Medical Device vs Quality Assurance Specialist Medical Device?

AspectQuality Engineer Medical DeviceQuality Assurance Specialist Medical Device
CertificationsISO 13485, Six Sigma, ASQ certificationsISO 13485, Six Sigma, ASQ certifications
Work EnvironmentDesign, development, manufacturing, and process improvementAuditing, compliance, documentation, and process verification
Employer & Industry UsageMedical device manufacturers, R&D labsMedical device companies, regulatory agencies, consulting firms

While both roles focus on quality in the medical device industry, a Quality Engineer Medical Device primarily works on product design, process development, and continuous improvement. In contrast, a Quality Assurance Specialist Medical Device emphasizes compliance, auditing, and ensuring adherence to regulatory standards. Both roles are essential for maintaining product safety and quality, but they differ in scope and daily responsibilities.

What are the key skills and qualifications needed to thrive as a Quality Engineer in the medical device industry, and why are they important?

To thrive as a Quality Engineer in the medical device industry, you need a strong background in quality assurance, regulatory compliance (such as ISO 13485 and FDA 21 CFR Part 820), and engineering principles, often supported by a relevant engineering degree. Familiarity with quality management systems (QMS), risk analysis tools (like FMEA), and certifications such as CQE (Certified Quality Engineer) are typically required. Attention to detail, problem-solving, and effective communication are critical soft skills for collaborating with cross-functional teams and ensuring product safety. These skills and qualifications are vital to maintain regulatory compliance, uphold product quality, and protect patient safety in a highly regulated environment.

What Does a Quality Engineer for Medical Devices Do?

As a quality engineer for medical devices, you oversee the continual improvement of medical devices as well as the design and manufacturing of new devices. Your duties are to develop prototypes, assess the quality of manufacturing standards, and develop guidelines for technological improvement. You also work closely with medical device engineers to ensure sufficient documentation and standardization, which helps users and service technicians test and maintain the safety of devices. Your responsibilities as a medical device quality engineer relate to all aspects of the product life cycle, from prototyping to the supply chain to production.

How does a Quality Engineer in the medical device industry typically collaborate with cross-functional teams to ensure product compliance?

Quality Engineers in the medical device sector work closely with cross-functional teams such as design, manufacturing, regulatory affairs, and supply chain. They participate in design reviews, risk assessments, and process validations to ensure that products meet both internal quality standards and external regulatory requirements (such as FDA or ISO 13485). Regular collaboration involves reviewing documentation, addressing non-conformances, and implementing corrective actions. This teamwork is critical to proactively identify potential issues and maintain continuous product quality throughout the development and production lifecycle.
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Quality Engineer Medical Device jobs near you
Validation Engineer (Medical Device)

Validation Engineer (Medical Device)

Caresoft

Rochester, NY • On-site

Other

Re-posted 4 days ago

Job description

Title: Valdiation Engineer (Medical Device)
Location: Rochester NY
Duration: 12 Months

Overview:
This role supports validation activities for new products within a medical device manufacturing facility and requires the ability to work both independently and as part of a cross-functional team.
Key Responsibilities
Support validation work for new products, including laboratory testing utilizing VITROS analyzers.
Prepare and handle clinical test specimens according to approved procedures, best practices, and safety requirements, including appropriate PPE.
Perform pilot-scale formulations with biological materials, as needed.
Operate and maintain laboratory equipment; complete all required documentation in real time (QC records, instrument logs, test records).
Independently execute laboratory experiments and assist with troubleshooting instrument and test failures, as needed.
Review and analyze data; document conclusions and test summaries in appropriate quality records within QuidelOrtho's quality system.
Ensure organization, documentation, and tracking of long-term studies with multiple factors, products, and conditions.
Maintain a working knowledge of cGMP requirements and adhere to all quality, regulatory, and safety guidelines.
This role involves both laboratory and computer-based work.
Skills Required:
Bachelor's degree in a scientific field (e.g., Chemistry, Biology, or equivalent) required.
Experience in an FDA-regulated industry and in validation for medical devices preferred.
Familiarity with VITROS products and VITROS analyzers highly desired.
Familiarity with biological formulations and processing techniques highly desired.
Strong written and verbal communication skills with excellent attention to detail required.
Strong organizational skills and ability to manage complex, long-term studies required.
Proficiency in Excel required, with additional statistical analysis skills preferred.

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