Description
Position Summary
The Quality Engineer II develops, implements, and improves commercial product quality requirements, and is committed to improving the quality of patient care and improving the effectiveness of the quality management system. As a high level and hands-on resource, this position leverages medical device quality, supplier and manufacturing experience to lead sustaining risk management activities, support root cause analysis, and provide technical support for process verification and validation activities.
Job Duties/Responsibilities
- Collaborate with cross-functional team (including Supply Chain, Manufacturing, Suppliers, Regulatory, etc.) to communicate, understand and solve quality problems.
- Evaluate product quality risks and acceptability of nonconforming materials
- Develops, maintains and evaluates risk management file including supporting FMEAs
- Provides investigative support for product quality issues.
- Utilize root cause analysis techniques to identify potential solutions to address those root causes within the corrective and preventive action system.
- Drive continuous improvements through observation, measurement and root cause analysis.
- Perform statistical analysis in support of root cause analysis, process control, and verification and validation activities.
- Develop new processes which support speed, cost reductions and quality improvements.
- Develop process validation requirements (IQ, OQ, PQ) and equipment qualifications.
- Manage the selection, qualification, and certification of responsible suppliers to provide materials that meet specifications for production requirements.
- Maintain supplier relationships that encourage technical input and contributions, as requested, concerning new products, processes, ideas, and improvements. Initiate actions required to maintain the supplier performance at high level.
- Adheres to the Company’s purpose operating principles, building a positive and productive team culture.
- Comply with Company policies and procedures.
- Authorized to access employee and/or patient PHI and ePHI only as needed for job-related functions.
- Other duties as assigned.
Requirements
Qualifications
- BS in Engineering from an accredited college or university or relevant education and experience.
- Minimum of 3 years of experience in an engineering role in the medical device industry.
- Experience with business process development
- Working knowledge in statistical analysis techniques
- Experience in test method strategies, development and validation including GR&R
- Experience with risk management methodology and experience with ISO 14971 or equivalent
- Experience with FDA QSR 21 CFR Part 820 and ISO 13485 or equivalent
- Preferred Lean Six Sigma Certification
- Ability to create and manage key internal and external partnerships
- High level of attention to detail
- Ability to demonstrate proficiency in issue resolution.
- Ability to manage multiple priorities with little direction.
- Familiar with product safety standards
- Demonstrated Project Management skills
- Excellent written and verbal communication skills.
- Proficient in using Microsoft office programs (Word, Excel, and PowerPoint).
- Willingness to work a flexible schedule.
- Able to travel for work as needed.
- Satisfactorily pass comprehensive background screening.
Physical Demands/Working Conditions
- Typical work environment for a professional office or home office space and occasionally works in a laboratory, supply room, and/or clean room environment.
- Largely a stationary role with some moving from place to place.
- Constant use of a computer, keyboard, mouse, monitor and other office equipment.
- Occasional use of laboratory equipment.
- Occasional interaction with radioactive materials.
- Requires some finite hand/eye coordination.
- Occasionally picks up, carries, and moves items up to 30 lbs.
- Some evening and weekend work depending upon workload.
- Some overnight travel may be required for work, events, and training.