Sponsor: Rubicon Genomics
Recording Date: 2/19/2014
Recording Time: 1 hour
The Incoming Quality Engineer will support incoming inspection by developing new/improved inspection methods and provide appropriate training to staff.
Work with the INC Supervisor to help improve the process of incoming inspection to include:
- Identify ways to increase inspection productivity by designing and fabricating inspection fixtures, techniques and methods.
- Work with engineers to identify and have inspected Critical To Function dimensions for each production part.
- Assist in the set up of Quality metrics for the INC Group and identify ways to track the group's productivity and quality of inspections.
- Initiate the resolution of nonconforming materials identified at Incoming Inspection, working with the consumable and instrument engineers and coordinating with representatives from other technical groups.
- Provide assessment of inspection capabilities to new product design teams and enhance inspection capabilities and toolsets where required to support new product launch.
- Implement efficiency and automation improvements to facilitate better data collection within the available resource pool.
- Understand and apply the manufacturing quality toolset including GR&R/measurement system analysis, control plans Cpk, Cp, SPC, hard gauging applications, computer-based inspection methods.
- Participate in cross-functional meeting involving Production Engineers, Process Engineers, and R&D Engineers.
- Work with product support teams, engineering and others on component quality issues and supplier initiatives.
- Direct vendor interactions including travel to supplier sites to coordinate and calibrate inspection techniques which will include gage R & R studies.
- Review drawings to evaluate quality requirements including correct application of geometric dimensioning and tolerancing (GD&T), proper use of engineering, process and material specifications, and identification of key characteristics for inspection plans and methods.
- Review engineering change orders to ensure inspection viability as well as develop inspection technique.
- Some group management skills in terms of supervising individual contributors and help with the development and skill set improvement.
- Bachelor's Degree in Engineering (Mechanical Engineering discipline is preferred).
- A minimum of 3 years of experience in similar position within a regulated industry (medical device, biotechnology, FDA/ISO, etc.).
- Highly knowledgeable in AQL sampling plans.
- Advanced skillset with Excel, Word, Minitab, and PowerPoint software.
- Ability to read and review mechanical drawings.
- Experience in Incoming Inspection processes and management.
- Experience in the application of production and process controls including process validation, process control plans and statistical process control.
- Superior communication skills, both oral and written.
- Ability to work effectively in a team environment and build strong working relationships.
- Ability to constructively challenge concerns and engage in transparent conversations.
- Ability to identify, analyze and solve problems with minimal direction and make decisions with confidence.
- Foster an environment that values diversity and inclusion.
- Strong attention to detail.
- Ability to successfully balance and prioritize multiple on-going projects/tasks (Project Management skills).
- High degree of initiative and self motivation.
- Strong analytical and problem-solving skills.
- Travel requirements up to 10-20% to vendor sites (domestic).
To apply for this position, please CLICK HERE