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About the Role
The Quality Assurance Engineer supports and maintains the Quality Management System (QMS) to ensure compliance with applicable regulatory requirements. This role partners cross-functionally to ensure product quality and compliance throughout the product lifecycle.
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.
- Analyze quality data and metrics to identify trends and drive continuous improvement.
- Performs other duties as assigned.
Requirements
- 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).
- 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.
Skills
- Technical writing
- Organizational skills
- Analytical skills
- Problem-solving skills
- Communication skills (written and verbal)
Location
- Buffalo, NY
Work Type
- Exempt
Experience Level
- 3-5+ years’ experience in Quality in GMP environment.
Education Level
- Bachelor’s Degree in Engineering, Life Sciences or related field.
Salary/Compensations
- $70,0000-$85,000
Benefits
- 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
Equal Opportunity
- All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.