The primary purpose of the Quality Engineer (Post Market) position at Cook Winston-Salem is complete and review post market quality engineering activities, including complaint investigations, risk assessment, post market feedback, and product quality issues.
• Perform complaint investigations, including technical assessment of returned products.
• Complete risk assessments using post market data.
• Assist with the investigation, risk assessment and resolution of product quality and quality system issues.
• Implement, support and maintain post-production quality activities.
• Support post market surveillance activities.
• Interface with internal and external resources in order to gather data related to field actions.
• Gather and prepare information necessary for Field Action Assessments.
• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
• Ensure the promotion of quality and regulatory requirements throughout the organization.
• Perform other duties as assigned.
• Four-year college degree in a technical discipline or equivalent work experience.
• Strong organizational skills.
• Strong analytical and problem-solving skills.
• Detail oriented.
• Experience with FDA QSR regulations and ISO standards preferred.
• Computer skills including experience with word processing, spreadsheet and database software applications.
• Must be able to perform essential functions of job, with or without reasonable accommodations.
• Work is performed in a normal working environment with majority of the day spent sitting and moving around various departments and multiple buildings around campus.
• Complaint evaluation work requires protective glasses and gloves when working with biologically contaminated returned products.
Equal Opportunity Employer
Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to supply sponsorship for employment visa status (e.g. H-1B or TN status) for this employment position.