Responsibilities Provide Quality Engineering support to production for quality activities and maintain oversight of manufacturing activities for quality compliance while assuring that products and process continue to operate in accordance with company policies and procedures. Operate in accordance with company policies and procedures, FDA Regulations, ISO Standards and Canadian Medical Device Regulations, where applicable. Responsibilities: Essential Duties Serve as a Quality representative to improve awareness, visibility and communication on quality initiatives to support departmental, functional, facility and corporate quality goals and objectives. Serve as primary contact for engineering support of the Quality Control department. Develop and maintain statistically valid sampling plans for engineering studies, validations and quality inspections. Review validation reports, engineering studies and product and process nonconformances and deviations to ensure thorough and accurate investigations with clear and concise conclusions. Conduct impact assessments for environmental and process deviations and nonconformances, including Out of Tolerance (OOT) calibration reports. Conduct and support investigations of manufacturing nonconformities and recommend, develop and implement effective corrective actions. Support production efforts and drive process improvements through the utilization of trend analysis, lean manufacturing principles, engineering studies, process and test method development and validation and statistical process control. Reduce process variability and mitigate root causes of defects. Support the transfer of new products and processes into manufacturing. Provide project direction, coaching and mentoring for company personnel. Proactively initiates the development of streamlined systems to effectively identify and resolve quality problems. Provides support during regulatory inspections and customer audits. Identify and implement quality system improvements when gaps are identified through audits and departmental reviews. Proactively investigates, identifies and implements improved Quality practices. Track and monitor metrics related to the production process and develop and implement programs designed to increase department and company employee awareness. Lead the implementation of continuous process improvement initiatives designed to meet or exceed internal requirements. Prepare and present trend reports to management. â?¢ Ensure personal training in accordance with department training matrix. â?¢ Ensure operations within approved department budget. Performs other related duties as required by management. Expertise: Knowledge & Skills â?¢ Knowledge of quality policies, FDA Regulations and ISO Standards for medical device or pharmaceutical operations. â?¢ Knowledge of CAPA, risk management, root cause investigation. â?¢ Strong knowledge in statistical process control and ability to apply statistical techniques. â?¢ Demonstrated use of Quality tools, principles and methodologies. â?¢ Must be able to work with all functional groups. â?¢ Must be able to work with all phases of company manufacturing and quality operations. â?¢ Excellent written and verbal communication and interpersonal skills â?¢ Must be able to effectively manage multiple priorities and projects â?¢ Proficient in the use of computers including a wide variety of word processing and spreadsheet software packages â?¢ Ability to make verbal presentations to both small and large groups at a variety of levels both inside and outside of the company. Qualifications Expertise: Qualifications - Experience/Training/Education/Etc. Required 4-5 years professional experience Bachelor's Degree required Responsibilities: Other Duties: The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. Options