Job Title: Quality Engineer
Reports To: Clinical & Quality Engineering Director
FLSA Status: Exempt
Primary Purpose: Plans and directs activities concerned with development, application, and maintenance of quality processes, materials, and products. Additionally, responsible for investigation manufacturing and customer nonconformance’s, determining root causes and corrective actions, reviewing and approving protocols and final reports and developing product specifications and sampling plans.
- Develops and initiates standards and methods for inspection, testing, and evaluation.
- Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
- Develops product specifications and sampling plans.
- Establishes program to evaluate precision and accuracy or production equipment and testing, measurement, and analytical equipment and facilities.
- Develops and implements methods and procedures for disposition and discrepant material and devises methods to assess cost and responsibility.
- Direct workers engaged in measuring and testing products and tabulating data concerning materials, product, or process quality and reliability.
- Reviews and approves validation protocols and final reports for equipment, product, and processes.
- Resolution and continuous improvement for root causes analysis, including NCR and Compliance.
- Investigates manufacturing and customer non-conformances (complaints) through root cause analysis.
- Develops and implements corrective action necessary to resolve NCR/CAPA issues.
- Conducts effectivity checks for all root cause analysis, CAPAs and document findings.
- Formulates responses to customer complaints.
- Facilitates improvement projects and teams.
- Interacts with customers and suppliers routinely to ensure that product quality is constantly maintained. Addresses all product quality issues for current products. Oversees and maintains all quality functions related to packaging and manufacturing.
- Participates in FDA inspections, ISO audits, and customer audits of the plant quality system.
- Performs supplier and internal audits.
- Minimum if BS in Engineering, Science or related technical field.
- Advanced degree.
Skills and Experience:
- Minimum of 1-3 years Quality Engineering related experience and/or training is required.
- Knowledge of QSR, ISO 13485, CFR 820 and EN regulations.
- Knowledge of process improvement, SPC and other statistical process methods.
- Knowledge of process and product validations.
- Experience in medical devices desired.
- Experience in product packaging desired.
- Experience in molding.
- Time Management: Performs assigned tasks/projects in time allotted; plans accordingly to meet productivity goals; prioritizes tasks/projects appropriately.
- Quality of Work: Performs assigned tasks with accuracy; takes price in work; follows all quality programs, processes, and procedures.
- Job knowledge: Has a clear understanding of job duties and responsibilities; can demonstrate knowledge and understanding of job duties and responsibilities; demonstrates necessary technical skills throughout work.
- Problem Solving: Proactively identifies problems; works methodically to identify root causes and come up with possible solutions; resolves problems considering all factors including efficiency, costs, benefits, and risks.
- Initiative: Has a drive within self to do a better job; seeks opportunities to improve and learn more; takes on additional responsibilities; drives projects forward.
- Communication: Provides accurate and clear information in a timely manner; listens; uses appropriate words and tone verbally in writing; presents information in way that is thorough and understandable.
- Relationships: Respects others; works to find common ground when dealing with issues; team player; effectively works with other functions.
- Self-Development: Self-aware of personal development opportunities; creates a plan for continued development; works with manager to accomplish development activities; invests in self.
- Safety: Follows all safety programs, processes, and procedures; identifies and reports potential hazards or violations; drives safety initiatives and policies.
- Drive For Results: Do everything possible to meet goals or deadlines; consistently meet or exceed commitments; aggressively pursue all assignments and projects until completion, focusing your own and others’ energy on what really makes a difference; actively seeking out opportunities to improve delivery of service and new ways of working.
Please submit your resume to firstname.lastname@example.org.