This quality inspector will actively work on orthopaedic new product development (NPD) instrumentation projects. This candidate will serve as one of the quality inspector representative on a project core team and must be able to effectively communicate with all levels of the organization. As a member of these cross-functional project teams, this individual will work closely with representatives from R&D, purchasing, manufacturing and quality engineering, as well as our external strategic suppliers. Excellent interpersonal skills along with strong analytical and problems solving skills, are essential.
As part of this position, this individual will be responsible for identifying best in class quality inspection methods on his/her assigned instruments, including collaborating with supplier quality and purchasing on the qualification and delivery of these instruments.
Candidate for this hands-on position should be able to use engineering and project management principles, tools, and practices as well as own the ability to quickly learn orthopaedic surgical techniques and our various instrument manufacturing processes.
The individual must be self-motivated and able to advance his/her own knowledge through training, independent investigation, and observation. In addition, candidate must be capable of working independently and in a team setting to support the advancement of new product development projects, in a timely and cost-effective manner. This includes leveraging best practices and knowledge from colleagues as well as from other companies within our Client's Family of companies, as necessary.KEY JOB RESPONSIBILITIES:
- Perform open set-up inspections utilizing a variety of inspection equipment and visual standards.
- Perform inspections of machine components, assemblies to support feasibility studies, manufacturing process development, and prototypes for new product development (NPD).
- Perform design reviews and provide Design for Inspection (DFI) and inspection cost feedback to manufacturing engineers and NPD teams.
- Be able to conduct in-process and final inspections confirming compliance to specifications.
- Research current and emerging technologies to identify potential lower cost inspection methods, utilizing six sigma and lean methodologies and knowledge where applicable.
- Identify and implement methods to effectively streamline and optimize our inspection processes.
- Actively participant in pre-production and regular meetings that purchasing holds with vendors, visiting suppliers' facilities as needed.
- Work closely with supplier quality and R&D on identifying and qualifying the vendors on critical to function and quality dimensions as well as performing process capability, COV, and GR&R studies.
- The ability to train manufacturing associates in various inspection techniques and equipment including CMM and Vision system.
- Maintain compliance with all company policies to all safety, QSR and environmental issues.
- A minimum of a High school diploma, G.E.D. or equivalent required. An Associate degree is preferred.
- Strong written and verbal communication skills required.
- Ability to work cross functionality with Quality Engineers, Manufacturing Engineers, New Product Development teams, Suppliers, and shop floor machinists required.
- 2 to 5 years of experience working in a Medical Device manufacturing environment preferred.
- Demonstrate ability to read and comprehend drawing requirements and GD & T is required.
- Experience using basic inspection equipment, comparator, Tool makers' microscope, profilometer are required.
- Experience working in a Good Manufacturing Practice (GMP) or another regulated environment preferred.
- Experience working in an environment that has gone through Lean process changes preferred.
- General knowledge of CMM and Vision System operation/programming is preferred.
- CMM experience on Brown & Sharp with PC-DMIS is a plus.
- CMM programming ability in either PD-DMIS/Calypso is a plus.
- Blue light scanner technology experience is a plus.
- Proficiency utilizing MS Office Suite (Word, Excel and PowerPoint) are required.
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