Position Summary:The Quality Engineer will be responsible for achieving the highest quality level of manufacturing quality and quality system performance while ensuring compliance with all company policies and procedures and maintaining compliance with US FDA and international medical device regulations and ISO 13485 quality system requirements. As a contributor to the quality engineering organization, this professional will be a self-motivated and characterized as an excellent problem solver. This person will play an integral role in maintaining and improving the quality management system, product quality, and manufacturing process quality.
Essential Functions:- Supports process optimization using design of experiments (DOE) and retrospective data analysis to understand and minimizes sources of process variation affecting products. Helps to identify key process input variables and key process output variables
- Supports the development, implementation, and improvement of production monitoring methods and systems for product inspection and testing
- Performs measurement systems analysis
- Supports the validation of manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ)
- Monitors and analyzes production information to support risk management and to provide direction for corrective and preventive actions and/or process improvement activities
- Applies Lean Six Sigma and Continuous Improvement concepts to eliminate waste, improve throughput, improve quality, and reduce cost
- Improves and maintains quality systems and tools for quality tracking, analysis, reporting, problem solving, and process improvement
- Utilizes concepts of probability and statistical quality control to guide decisions
- Integrates quality engineering methods to support co-workers and business objectives for product and process quality and problem resolution
- Establishes, follows, and improves company procedures
- Provides written and oral reports to supervisor or other management personnel to keep them informed of activities and results
- Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
- Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
- Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Qualifications:- Bachelor's Degree required (science or engineering preferred)
- 3-5 years' experience in quality assurance; experience in the medical device industry preferred
- GMP and ISO experience
- Strong proficiency in MS Office with knowledge of statistical analysis tools
- Knowledge of Lean Manufacturing, Six Sigma, and reliability engineering is a plus
- Must be a team player capable of working in a deadline dictated environment
- Excellent verbal and written communication skills
Physical Demands:The physical demands listed here are representative of those that must be met by and employee to successfully perform the essential functions of this job.
- Required to sit; climb or balance; and stoop, kneel, crouch or crawl
- Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds
Other Duties:Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
