Engineer, Quality

Antylia Scientific; Buffalo (NY); On-site; USD 70,000 - 85,000; Full time

Benefits offered by this job

Salary range demonstration

Medical, Dental, Vision Insurance

401(k) company match

Paid Time Off

Paid Holidays

Tuition Assistance

Job summary

Antylia Scientific in Buffalo, NY is seeking an Engineer, Quality Assurance to support the Quality Management System, ensuring compliance with FDA, ISO 13485 and 21 CFR Part 820 throughout the product lifecycle. You will partner with R&D, Manufacturing and Regulatory Affairs to maintain product quality and regulatory compliance.

The role includes participating in design controls, CAPA investigations, ISO 14971 risk management, and audits, with responsibilities spanning supplier quality and

Qualifications

• Bachelor’s Degree in Engineering, Life Sciences or related field.
• 3-5+ years’ experience in Quality in GMP environment.
• ASQ CQE or similar certification preferred.

Responsibilities

• 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.

Skills

GMP experience

Quality Assurance

Regulatory knowledge

FDA/ISO 13485

Auditing

Education

Bachelor’s Degree in Engineering, Life Sciences or related field

Tools

MasterControl

Job description

Job Title

Engineer, Quality Assurance

Reports To

Manager, Quality or Sr. Manager, QA/RA

Position Location

Buffalo, NY

FLSA Status

Exempt

Position Summary

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.

Key Responsibilities

• 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.

Education

• Bachelor’s Degree in Engineering, Life Sciences or related field.

Experience

• 3-5+ years’ experience in Quality in GMP environment.

Preferred Qualifications

• 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.

Minimum Requirements/Qualifications

• 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

Other

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.