Maintains quality records on product testing, nonconformance, project outcomes, and stakeholder input filed in an accurate and timely manner.
Coordinates change control documentation and approval process. makes proposals and assists in the development of corrective action plans and monitors implementation.
Follows up on closure of corrective and preventive actions.
Provides quality support for technology transfer and improvement of existing manufacturing processes.
Conducts investigations, collects data, analyzes trends and prepares reports for assigned quality processes.
Assesses current quality systems and recommends improvements in order to enhance quality and reduce cycle time.
Prepares for and facilitates audits and inspections.
Monitors trends, identifies issues, recommends and implements appropriate actions. Assists in the development, implementation and review of standard operating procedures for interactions with contract manufacturers.
Knowledge, Skills, Competencies and Experience
Education: (minimum required for competent performance in this position) Healthcare/Bioengineering Bachelor degree is required.
Additonal Qualification:ISO 9001 or ISO 13485 Lead Auditor or ASQ certifications is preferable.
Skill Sets and Competencies:
Years of experience: 2-4 years working in Healthcare Pharmaceutical/Biotechnology/Medical Devices) Quality Assurance is required.
Approximately 0-5% travel is required.