Quality Assurance Coordinator-Manufacturing Environment

MediTrac by Flex-Trac, Inc., a subsidiary of Omega Flex, Inc is seeking an experienced Quality Assurance Coordinator for our manufacturing facility in Exton, PA.

The Quality Assurance Coordinator will have responsibilities for the implementation and maintenance of the Quality Management Systems including ISO 9001:2015 and EN ISO 13485:2016, internal audits, operating procedures, regulatory compliance, supplier quality, and continuous improvement activities.

Main Responsibilities:

• Assist in development of Quality Management System procedures and technical files to ensure conformance to ISO Standards and Regulatory requirements for Class IIa Medical Device.
• Perform internal audits to ensure compliance to ISO Standards and Regulatory Agencies, including investigation, identifying observations and findings, and reporting to Notified Bodies, and Competent Authorities.
• Monitor and/or perform quality activities to support First Article Inspection and in-house product testing.
• Review procurement documents for flow down and inclusion of quality requirements.
• Coordinate supplier evaluation and maintenance.
• Work closely with Manufacturing Operations to investigate product quality issues, determine root cause, gather, and analyze data and implement corrective action to reduce or eliminate cause.
• Maintain preventive maintenance and calibration data to ensure conformance with regulatory requirements and ISO standards.
• Perform quarterly product verification testing.

Qualifications and Experience: We believe that the ideal candidate has the following qualifications and experience:

• Minimum of 3 years' experience in engineering or equivalent technical background with progressive experience in quality management systems or regulatory compliance.
• Strong organizational and time management skills with the ability to work under pressure and meet deadlines.
• Highly motivated and able to work independently.
• Excellent written and verbal communication skills.
• Strong problem-solving and decision-making abilities.
• Experience working with regulatory quality standards preferred
• Experience in Medical Device Regulations preferred but not required.

Compensation: In addition to competitive pay and a great work environment, Flex-Trac offers excellent benefits including the following:

• Medical Insurance
• Dental Insurance
• Vision Insurance
• 401k with company match and profit-sharing
• 10 paid holidays per year
• Paid vacation time
• Paid sick time
• Life insurance coverage for employees and family
• Short-Term and Long-Term Disability Insurance

This is an on-site position, no remote or hybrid work schedule is available. The selected candidate will be required to successfully complete a company paid pre-employment physical, drug test, and employment background screen. For consideration, please submit your resume.