J&J Family of Companies Staff Supplier Quality Engineer in Monument, Colorado
DePuy Synthes Companies of Johnson & Johnson is seeking a Staff Supplier Quality Engineer to be located in Monument, CO.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic 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.
The Staff Supplier Quality Engineer (SQE) provides overall quality assurance and quality engineering leadership in the management of contract manufacturing suppliers, including Finished Good Medical Devices, Direct and Indirect Material/Service Suppliers which can impact Johnson and Johnson production and/or sale of J&J product. The Staff SQE provides guidance, recommendations and leads all improvement aspects of the Supplier Quality Program. The Staff SQE may have responsibility in the day-to-day management and supervision of local and remote employees.
Position duties & responsibilities:
The Staff SQE influences, motivates and leads day-to-day and strategic activities in the lifecycle management of suppliers. As a Staff SQE, you will establish clear expectations and collaborate with internal and external partners that lead to consistent, reliable, quality products and services. Activities include but are not limited to:
The selection, categorization and qualification of suppliers and associated processes.
Adding, removing and updating quality system supplier information while ensuring accurate supplier information on the Approved Supplier List.
Establish, maintain and improve quality systems which demonstrate robust and comprehensive supplier quality records.
Drafting, establishing and providing relevant information detailed in quality and change agreements.
Executing and documenting supplier non-conformance reports (NCRs), Supplier Corrective Action Requests (SCARs) and Corrective and Preventive Actions (CAPAs).
You will define and lead actions related with Supplier Change Requests.
Leading and supporting supplier assessments and audits for compliance to regulations, agreements, standards and documented processes.
Propose and lead the development and improve comprehensive measurement systems for the SQ program and supplier quality performance. The individual may report on such metrics at Quality System management reviews.
Ensure systems to measure, assess risk and escalate quality events. Manage quality events to identify, bracket, correct, control and prevent defects
Leading and documenting internal supplier quality procedure change efforts. The individual will adhere/comply with and utilize multifaceted industry and process excellence standards on an expert level, including good manufacturing practices (GMP), equipment engineering system (EES), international organization for standardization (ISO) and country/governmental regulations. FDA CFR Part 820 and ISO 13485 regulations/standards will be the focus.
Lead and manage complex supplier quality efforts to include New Supplier / Product Introductions and manage cross-functional teams to accomplish project deliverables.
Support and/or lead program/plant/facility/franchise/enterprise based initiatives and projects as required.
A Bachelor's Degree is required. A Master’s Degree is preferred. Degree’s in Engineering, Life Science, or related discipline is preferred.
You will have a minimum of 6 years of experience in a GMP and/or ISO regulated industry. Experience in the medical device and/or pharmaceutical industry is preferred.
You are a subject matter expert in FDA and ISO regulations. FDA CFR Part 820 and/or ISO 13485 knowledge is preferred.
Auditing background is preferred.
Excellent communication, partnership, and analytical skills are required.
You have expertise in all aspects of quality event investigations such as root cause analysis and determination followed by comprehensive corrective action suggestions.
Experience and/or knowledge with machining manufacturing processes and injection molding is preferred.
Six Sigma, Lean, or ASQ Certification and trainings are preferred.
You have experience with CNC Milling and Turning; Press Breaking and Punching, Assembly; Metal Laser Etch; Silk-Screen, and Metal Processing such as passivating anodizing and heat treating.
This position will be located in Monument, Colorado and require up to 25% travel.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies areequal opportunity employers, and all qualifiedapplicants will receive consideration for employmentwithout regard to race, color, religion,sex, sexual orientation, gender identity, geneticinformation, national origin, protected veteranstatus, disability status, or any othercharacteristic protected by law.
Depuy Orthopaedics. Inc. (6029)