Job Title: Engineer, Quality Assurance Reports To: Manager, Quality or Sr. Manager, QA/RA Position Location: Buffalo, NY FLSA Status (Exempt/Non-Exempt): Exempt About Antylia Scientific: At Antylia Scientific, we believe…
Skills: Quality management system, ISO 13485, 21 CFR Part 820, CAPA investigations, Root cause analysis
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$70k–$85k/yr
Full-time
bachelor degree
Medical insurance, Dental insurance, Vision insurance, Disability insurance, Life insurance, 401(k) company match
Posted 30d ago
~40 hrs/week
Responsibilities
The Quality Assurance Engineer supports and maintains the Quality Management System to ensure compliance with regulatory standards like ISO 13485 and FDA requirements. They collaborate cross-functionally to manage design controls, CAPA investigations, risk management, and validation activities throughout the product lifecycle.
Requirements
Candidates must have a Bachelor's degree in Engineering or Life Sciences and 3-5+ years of experience in a GMP environment. Proficiency in medical device regulations, technical writing, and quality audit processes is required.
Full job description
Job Title: Engineer, Quality Assurance
Reports To: Manager, Quality or Sr. Manager, QA/RA
Position Location: Buffalo, NY
FLSA Status (Exempt/Non-Exempt): Exempt
About Antylia Scientific:
At Antylia Scientific, we believe the future of science is shaped by the collective power of expertise.
As the home of trusted scientific brands—including Cole-Parmer, Environmental Express and ZeptoMetrix—we bring together specialized knowledge, innovative products, and dedicated people to help laboratories, manufacturers, healthcare organizations, and researchers around the world solve complex challenges and improve lives.
Our teams support customers across life sciences, diagnostics, environmental, industrial, and academic markets with solutions that advance research, improve quality, protect communities, and drive scientific progress.
What makes Antylia unique is the expertise of our people. Across our brands and functions, we collaborate to share knowledge, solve problems, and create better outcomes for our customers. Every employee contributes to a culture built on innovation, integrity, collaboration, and continuous improvement.
If you're passionate about making an impact through science, technology, and customer-focused innovation, you'll find opportunities to grow your career while helping shape the future of science.
About the Job:
The Quality Assurance Engineer is responsible for supporting and maintaining the Quality Management System (QMS) to ensure compliance with all applicable regulatory requirements, including but not limited to ISO 13485 and 21 CFR Part 820. The Quality Assurance Engineer partners cross-functionally with R&D, Manufacturing, and Regulatory Affairs to ensure product quality and compliance throughout the product lifecycle, from design and development through commercialization.
How You Will Contribute:
Support and maintain the Quality Management System (QMS) in compliance with FDA, ISO 13485, CMDR and TGA requirements.
Participate in design control activities, including Design and Development File documentation and design reviews.
Participate in CAPA investigations, including performing root cause analysis and implementation of corrective and preventive actions.
Conduct risk management activities in accordance with ISO 14971.
Perform the intake, assessment, investigation and resolution of customer complaints.
Support process, software and equipment validation activities (IQ/OQ/PQ) and ensure proper documentation.
Support internal and external audits (FDA, notified bodies, and customers).
Review and approve change controls, deviations, and nonconformance reports.
Collaborate with manufacturing to address quality issues and improve processes.
Support supplier quality activities, including supplier qualification and monitoring.
Provide guidance and training to employees on quality standards, processes, and regulations to enhance overall awareness and adherence to quality requirements.
Analyze quality data and metrics to identify trends and drive continuous improvement.
Performs other duties as assigned.
What You Will Bring That Excites Us:
Bachelor’s Degree in Engineering, Life Sciences or related field.
3-5+ years’ experience in Quality in GMP environment.
ASQ Certified Quality Engineer (CQE) or similar certification.
Experience with regulatory submissions (510(k), CE Marking) is a plus.
Experience with eQMS systems (e.g., MasterControl).
Experience with risk management (ISO 14971) and validation activities.:
Working knowledge of current FDA, ISO 13485, CMDR and TGA medical device regulations.
Ability to respond to internal and external quality audits and perform root cause analysis and risk assessment activities.
Proficiency with Microsoft Office software (e.g. Microsoft Word, PowerPoint, Excel).
Excellent technical writing and organizational skills.
Familiarity with design controls and product lifecycle management.
Strong analytical, problem-solving, and communication skills, both written and verbal, to clearly and concisely communicate to all levels of the organization.
Strong work ethic and an ability to excel within a rapidly changing and growing organization.
Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines or other time essential constraints.
What We Offer:
Salary Range: $70,0000-$85,000, depending on location, experience, and qualifications.
Benefits coverage begins day one, including the following:
Medical, Dental, Vision Insurance
Disability Insurance
Life Insurance
401(k) company match
Paid Time Off (15 days annually)
Paid Holiday time (10 company-designated days)
Tuition Assistance
Additional benefits available with company package
This position has not been approved for Relocation Assistance.
The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all of the duties and responsibilities associated with it.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.
Speed your scientific discovery with products from Cole-Parmer since 1955. We are a global manufacturer of lab equipment and supplies for research and process. Our products have been used extensively in life sciences, clinical, academic, biotech, and research laboratories for over 65 years. We pride ourselves on our proprietary Cole-Parmer and Traceable® portfolios of high-quality products. We also partner with a select set of key suppliers with industry-leading products. We are renowned for offering exceptional service and technical support. Our team of technical support representatives are highly trained product experts with scientific backgrounds and industry experience. They are here to help you select products, troubleshoot existing products, and solve regulatory compliance issues. For more information, visit www.coleparmer.com.
Offices: 625 Bunker Ct, Vernon Hills, Illinois 60061, US
technical supportlaboratory equipmentindustrial equipmentinstrument calibrationinstrument repairtemperature measurementtemperature controlelectrochemistrylife scienceand research
How many Engineering jobs are open in Buffalo, NY right now?
There are currently 479 open engineering positions in Buffalo, NY listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Engineering roles in Buffalo, NY?
Companies currently hiring include M&T Bank, GTI Fabrication, Northrop Grumman Mission Systems, Inc., Schneider Electric, Northrop Grumman, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Engineering jobs in Buffalo, NY?
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