QUALITY ENGINEER
Responsibilities:
- Implement Quality System in accordance with cGMP and ISO standards
- Oversee and participate in quality activities-related inspection and disposition of raw materials, work in process, and finished products
- Oversee all aspects of the product/process Validation Program, including IQ/OQ/PQ protocols, monitoring, and preparation of reports
- Lead quality assurance tasks in development and manufacturing to ensure processes are capable and quality tools and systems are in place through product life cycle
- Analyze product quality performance data to identify high priority issues relating to safety and customer dissatisfaction
- Lead investigative teams to determine root causes of quality issues related to design and manufacturing
- Provide training to ensure proper implementation and use of quality tools and procedures
- Assist in the preparation of product documentation and technical presentations
- Support implementation of corrective actions to solve production/quality issues
Education:
- BS / MS in Mechanical Engineering, Chemical Engineering, or related discipline
- Training in quality engineering and procedures
Experience & Skills:
- 5+ years in a quality engineering role in the medical device or pharmaceutical industry
- Demonstrated proficiency in equipment and process validation methods
- Solid knowledge of current Good Manufacturing Practices (cGMP) for both pharmaceuticals and medical devices
- Experience with statistics, SPC process control, and ability to analyze data and interpret results
- Effective communication and interpersonal skills, including technical report preparation and ability to multi-task and prioritize responsibilities to meet schedules
As a professional search firm, we will only be responding to those inquiries that most closely align with the stated requirements. Please include the position ID "CC-1614" in the subject line of your correspondence to ensure review and forward your credentials (* Word format please) in confidence to: recruiter10@ccesearch.com
