Engineer, Quality

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

7 days ago Requisition ID: 2144

Job Title: Engineer, Quality Assurance

Reports To: Manager, Quality or Sr. Manager, QA/RA

FLSA Status (Exempt/Non-Exempt): 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 torespond 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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.