Supplier Risk Engineer Job in Warsaw, Indiana US
DePuy, Inc. a member of the Johnson Johnson Family of companies is recruiting a Supplier Risk Engineer to be located in Warsaw, IN.
DePuy, Inc. - Develops and markets products under DePuy Orthopaedics, Inc., DePuy Spine, Inc., Codman Shurtleff, Inc. and DePuy Mitek. Among these are products for reconstructing damaged or diseased joints; repairing and reconstructing traumatic skeletal injuries; facilitating the treatment of spinal disorders and deformity; surgical treatment of neurological and central nervous system disorders, and sports medicine devices for the treatment of soft tissue injuries. DePuy has three main locations: Warsaw IN, Raynham Ma and Leeds, UK. DePuy is one of the largest businesses within Johnson Johnson.
The Supplier Risk Engineer will reduce the level of supplier related risk to DePuy by leading risk identification and mitigation efforts with our highest risk suppliers. This will involve leading product/process audits, quality system audits and engineering reviews and driving projects and actions to mitigate identified risk areas. The role will also involve communicating risk reduction activities to SMC's, risk reviews and the wider supplier quality organization.
The Supplier Risk Engineer will lead activities to proactively identify and mitigate risk at suppliers. She/he will lead quality system and product/process audits to good manufacturing practices, ISO, FDA and any other applicable standards. This individual will lead engineering reviews of high risk products and services sourced from 3rd parties. The candidate will establish, monitor and implement supplier risk mitigation plans.
The Supplier Risk Engineer will lead the compilation and communication of audit results, resultant risks and recommendations to supplier quality engineers, the Supplier Management Committee (SMC) and Management Review. This individual will support supplier escalation process and SMC's. She/he will Identify and drive implementation of best practices/processes at suppliers, and participate in supplier risk management projects as needed. The candidate will monitor and drive on time completion of supplier risk mitigation projects
The Supplier Risk Engineer will ensure management awareness of risks, gain support for mitigation efforts and track progress. She/he will participate in local site SQ meetings to ensure communication and alignment of risk management initiatives with local site activity. Additionally, The candidate will utilize multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO).
Qualifications
A minimum of a Bachelor's degree, in an Engineering, Life Science, or related discipline is required. A Master's degree in engineering/scientific or associated relevant technical / engineering discipline is preferred. Minimum 5 years experience in a regulated industry is required, preferably in the medical device industry. Knowledge of FDA and ISO regulations is required. Knowledge and experience with FDA CFR Part 820 and ISO 13485 knowledge is preferred. Training as a Qualified Lead auditor (such as CQA) is required. Strong root cause analysis skills are required. Strong communication, teamwork, and problem solving skills are required. Demonstrated ability to lead improvement projects with suppliers is required. Experience and knowledge of one or more special processes used in production of Orthopedic products, for example: Heat treatment, passivation, sterile packing, forging, welding, laser marking are preferred. Six Sigma, Lean, or ASQ Certification and training are preferred. This position is located in Warsaw, IN and requires up to 50% travel.
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