.. Basic Qualifications: BS in Pharmacy or Pharmacist Degree from an accredited educational institution. Current pharmacist licensure in the states within the district. Experience performing prescription dispensing activities that demonstrate a strong working knowledge of applicable state and federal controlled .. read more
This position is responsible for applying advanced quality engineering principles and theoretical knowledge to solve quality problems and develop, implement, and monitor, quality systems and processes. This position works closely with manufacturing operations and engineering teams to solve problems, develop solutions and improve productivity while ensuring compliance to customer and regulatory requirements (AS9100, ISO9001, CFR, FAA) and our quality management system.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
• Has full responsibility to achieve results by identifying technical opportunities and recommends programs important to the business, implements systems, methods, and procedures, is sought after as a technical expert
• Data Collection - Collect data, conduct evaluations and tests to identify defective components and products and work closely with production staff, supervisors and engineering teams to problem solve, develop and implement solutions
• Support - Provide support in executing all requirements of established systems
• Problem Solving - Coordinate and manage resolution of problems using advanced methodologies as defined by internal and external customers. Lead investigations to identify root causes and implement containment and corrective actions.
• Compliance - Identify, develop, and establish systems to enable company-wide compliance with all applicable regulations both voluntary and compulsory.
• Leadership - Acts as project leader, identifies and interprets business impact of events. Provide direct quality to support manufacturing operations.
• Continuous Improvement - Drive continuous improvement initiatives with a focus on improving yield, reducing variation and standardizing processes.
• Quality System - Lead and manage product and process audits to ensure compliance as well as implement solutions and opportunities for improvement
• Participate in FMEA reviews and assist in developing solutions for mitigating risks
• Conduct failure analysis and implement corrective and preventative actions for customer returned product.
• Support current and new production development and validation activities to ensure products meet design, quality and manufacturing requirements
• Assist in execution of PPAP / APQP for new products
• Responsible for understanding industry standards, customer requirements and ensuring compliance throughout all aspects of the business
• Responsible for MRB support in processing and dispositioning nonconforming product
• Implement methods to inspect, test and evaluate the reliability of manufacturing processes, products and production equipment
• Perform other duties as assigned
QUALIFICATIONS
Required Qualifications
• Technical Bachelor’s Degree (or 5-8 years’ experience in a technical field) and Professional Certification. Technical Master’s Degree preferred.
• Strong problem-solving, analytical, organizational and critical thinking skills. Must have knowledge and experience in root cause corrective action methods such as 8D problem solving
• Must be qualified to work in an ITAR regulated environment
• Ability to effectively manage projects
• Ability to read engineering drawings and interpret specifications
• Proficient in Microsoft Office Applications
• Proficient in Minitab
• Experience using ERP/MRP systems
• Excellent verbal and written communication skills
• Strong Follow Through, Collaboration, Action Focus, Navigating Ambiguity, Self-Directed, Effective Communication, Capacity for Systems Thinking, Customer Focus skills are required.
• Ability to manage multiple tasks simultaneously and be able to react to shifting priorities to meet business needs
Preferred Additional Qualifications
• Auditing experience
• Knowledge and understanding of Aerospace Standards
• Knowledge and experience with inspection and test methods
PHYSICAL REQUIREMENTS
Hearing: Adequate to perform job duties in person, over the telephone, and on the production floor.
Speaking: Must be able to communicate clearly in person, over the telephone, and on the production floor.
Vision: Visual acuity Eyesight 20/25 with or without correction. Will be required to take and pass a color blindness test for visual inspections.
Other: Requires frequent lifting and carrying items weighing up to 30 pounds unassisted, including assisting co-workers when required. Adequate physical ability including sufficient manual dexterity to perform the requisite inspection duties. Requires frequent bending, reaching, repetitive hand movements, standing, walking, squatting and sitting, with some heavy lifting, pushing and pulling exerted regularly throughout a regular work shift.
Status: Exempt / Salary
Salary Range: $64,000- $110,000
Shift: Office Onsite
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
• Has full responsibility to achieve results by identifying technical opportunities and recommends programs important to the business, implements systems, methods, and procedures, is sought after as a technical expert
• Data Collection - Collect data, conduct evaluations and tests to identify defective components and products and work closely with production staff, supervisors and engineering teams to problem solve, develop and implement solutions
• Support - Provide support in executing all requirements of established systems
• Problem Solving - Coordinate and manage resolution of problems using advanced methodologies as defined by internal and external customers. Lead investigations to identify root causes and implement containment and corrective actions.
• Compliance - Identify, develop, and establish systems to enable company-wide compliance with all applicable regulations both voluntary and compulsory.
• Leadership - Acts as project leader, identifies and interprets business impact of events. Provide direct quality to support manufacturing operations.
• Continuous Improvement - Drive continuous improvement initiatives with a focus on improving yield, reducing variation and standardizing processes.
• Quality System - Lead and manage product and process audits to ensure compliance as well as implement solutions and opportunities for improvement
• Participate in FMEA reviews and assist in developing solutions for mitigating risks
• Conduct failure analysis and implement corrective and preventative actions for customer returned product.
• Support current and new production development and validation activities to ensure products meet design, quality and manufacturing requirements
• Assist in execution of PPAP / APQP for new products
• Responsible for understanding industry standards, customer requirements and ensuring compliance throughout all aspects of the business
• Responsible for MRB support in processing and dispositioning nonconforming product
• Implement methods to inspect, test and evaluate the reliability of manufacturing processes, products and production equipment
• Perform other duties as assigned
QUALIFICATIONS
Required Qualifications
• Technical Bachelor’s Degree (or 5-8 years’ experience in a technical field) and Professional Certification. Technical Master’s Degree preferred.
• Strong problem-solving, analytical, organizational and critical thinking skills. Must have knowledge and experience in root cause corrective action methods such as 8D problem solving
• Must be qualified to work in an ITAR regulated environment
• Ability to effectively manage projects
• Ability to read engineering drawings and interpret specifications
• Proficient in Microsoft Office Applications
• Proficient in Minitab
• Experience using ERP/MRP systems
• Excellent verbal and written communication skills
• Strong Follow Through, Collaboration, Action Focus, Navigating Ambiguity, Self-Directed, Effective Communication, Capacity for Systems Thinking, Customer Focus skills are required.
• Ability to manage multiple tasks simultaneously and be able to react to shifting priorities to meet business needs
Preferred Additional Qualifications
• Auditing experience
• Knowledge and understanding of Aerospace Standards
• Knowledge and experience with inspection and test methods
PHYSICAL REQUIREMENTS
Hearing: Adequate to perform job duties in person, over the telephone, and on the production floor.
Speaking: Must be able to communicate clearly in person, over the telephone, and on the production floor.
Vision: Visual acuity Eyesight 20/25 with or without correction. Will be required to take and pass a color blindness test for visual inspections.
Other: Requires frequent lifting and carrying items weighing up to 30 pounds unassisted, including assisting co-workers when required. Adequate physical ability including sufficient manual dexterity to perform the requisite inspection duties. Requires frequent bending, reaching, repetitive hand movements, standing, walking, squatting and sitting, with some heavy lifting, pushing and pulling exerted regularly throughout a regular work shift.
Status: Exempt / Salary
Salary Range: $64,000- $110,000
Shift: Office Onsite