Quality Assurance Engineer – GMP/Regulatory

Cole--parmer-Instrument-Company; Buffalo (NY); On-site; USD 70,000 - 85,000; Full time

Benefits offered by this job

Medical, Dental, Vision Insurance

401(k) company match

Paid Time Off 15 days annually

Paid Holidays 10 days

Job summary

Cole-Parmer Instrument Company in Buffalo, NY is seeking a Quality Assurance Engineer to support and maintain the Quality Management System (QMS) and ensure regulatory compliance (ISO 13485, 21 CFR Part 820) throughout the product lifecycle.

This role partners with R&D, Manufacturing and Regulatory Affairs to address quality issues, participate in design controls and CAPA, perform risk management, and contribute to supplier quality and staff training.

Qualifications

• Knowledge of QMS and regulatory frameworks (FDA/ISO) and ability to maintain documentation.
• Experience applying CAPA, risk management and design controls in medical device projects.
• Proficient in conducting internal/external audits and writing clear reports.

Responsibilities

• Support and maintain the QMS in compliance with FDA, ISO 13485, CMDR and TGA.
• Participate in design control activities and reviews.
• Conduct CAPA investigations with root cause analysis and corrective actions.
• Perform risk management per ISO 14971.
• Handle intake, assessment, investigation and resolution of customer complaints.
• Support validation activities (IQ/OQ/PQ) and document proper records.
• Assist audits by internal and external bodies.
• Review and approve change controls, deviations, and nonconformance reports.
• Collaborate with manufacturing to address quality issues.
• Support supplier quality activities including supplier qualification.
• Provide guidance and training on quality standards.
• Analyze quality data to identify trends and drive improvement.
• Performs other duties as assigned.

Skills

QMS knowledge

Regulatory audits

CAPA investigations

Risk management

Design controls

Root cause analysis

Data analysis

Technical writing

Education

Bachelor’s Degree in Engineering or Life Sciences

Tools

MasterControl

MS Office

Regulatory submissions (510(k))

Job description

Cole-Parmer Instrument Company in Buffalo, NY is seeking a Quality Assurance Engineer to support and maintain the Quality Management System (QMS) and ensure regulatory compliance (ISO 13485, 21 CFR Part 820) throughout the product lifecycle.

This role partners with R&D, Manufacturing and Regulatory Affairs to address quality issues, participate in design controls and CAPA, perform risk management, and contribute to supplier quality and staff training.