DePuy Synthes is recruiting for a Lead Inspector – 3rd Shift, located in Monument, CO.
DePuy Synthes is a Johnson & Johnson company that is one of the leaders in the medical device industry. Our implants and instruments are used by orthopedic surgeons to treat patients with conditions resulting from traumatic injuries, degenerative diseases, deformities, and sports related injuries. Our environment is entrepreneurial, learning-driven, and is as challenging as it is rewarding.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
Inspection and Device History Record (DHR) responsibilities include:
- Perform higher-level inspection services with minimal instruction including those associated with first article inspection, process test and validation.
- Inspect incoming, in process and finished products and material for visual, mechanical, and dimensional characteristics, using inspection sheets and applicable sampling plans.
- Communicate issues arising from daily builds and field reports that should be reviewed by a Supervisor or Engineer showcasing ability to prioritize effectively.
- Inspect in-house and vendor purchased products, including raw material and services.
- Works from inspection documentation, specifications, blue prints, written and verbal instructions.
- Prioritize daily processing of designated orders through inspection to eliminate backorders and low inventory items through partnership with department inspectors.
- Assist the Supervisor in coordinating and prioritizing product flow through inspection personnel to meet business needs.
- Provide support by filling in for absences in critical areas within departments and acts as technical resource for improvement projects.
- Coordinate the department’s schedule and assist in the training of co-workers in new or improved techniques in multiple areas.
- Assist in determining root cause of non-conformance in complaint investigation process.
- Performs “Roving and Process Inspections” function involving inspection of product and process in a Manufacturing Flow Cell.
- Perform Device History Record (DHR) review and “Release to Branch Plant” function including document verification and recording incoming inspection inventory.
- Performs filing and supports the imaging and verification process for Device History Records and other Quality System documentation.
- Know and follow all laws and policies that apply to one’s job, and maintain the highest levels of professionalism, ethics and compliance at all times.
- Diligently participate in our compliance program-related activities as denoted by your Supervisor or our Chief Compliance Officer.
- Report to the Inspection Supervisor of the Quality Assurance department.
- A minimum of
a High School diploma, G.E.D. or equivalent required.
- A minimum of
2 years of inspection experience is required.
working within a highly regulated environment is required.
working within the Medical Device, Pharmaceutical and/or Life Sciences
computer skills required.
- Knowledge of
Microsoft Word, Excel and Outlook preferred.
with Material Requirements Planning (MRP)/Enterprise Resource Planning
(ERP) systems preferred.
- Knowledge of
JD Edwards (JDE) preferred.
- Basic math
skills, with the ability to add, subtract, multiply, divide, compute
percentages and work with decimals and fractions, required.
- Strong color
verification skills and good hand/eye coordination is required.
using measuring instruments utilized in Quality Assurance (i.e. gauges,
micrometers, calipers, comparators) is preferred.
weight up to 20 pounds on regular basis and up to 50 pounds on occasional
- Must have a
proven track record of demonstrating leadership capabilities.
- High level
of concentration and attention to detail required.
- Must be able
to work 3rd Shift (10:00 pm - 6:30 am).
- The ability
to work occasional overtime and off-shift hours is required.
Depuy Orthopaedics. Inc. (6029)Job Function
Quality ControlRequisition ID