Senior Quality Control Supervisor (Duration-Based)
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DePuy Synthes, a member of the Johnson & Johnson Family of Companies, is currently recruiting for a Senior Quality Control Supervisor.
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.\
Johnson & Johnson DELIVER Group is part of Johnson & Johnson’s global Supply Chain organization supporting operations across all of the Johnson & Johnson Family of Companies. DELIVER strives to deliver an extraordinary customer experience through leading critical customer-facing-functions such as customer service, distribution and transportation. In addition, DELIVER oversees critical business enablers, including how we bring together and lead supply chain master data, safe and secure supply chain practices, product identification standards, and market/channel access capabilities. It supports all three sectors of Johnson & Johnson: Medical Devices (including Vision), Pharmaceutical, and Consumer Products. Located in every region of the world where Johnson & Johnson operates, Deliver is a critical component of our supply chain, working collaboratively to ensure that quality, safety and the experience of our customers is our top priority.
As the Senior Quality Control Supervisor, you are responsible for ensuring company products are in compliance with internal and external specifications by managing and supervising the Incoming Inspection department, which performs a variety of routine and non-routine inspections and evaluations. The department of Incoming Inspection performs a variety of product inspections, generally of finished goods, components, packaging materials, incoming materials or new products, by observing, measuring and recording data.
This is a duration-based position with an anticipated completion time frame of 24-36 months.
• Responsible for managing and supervising the Incoming Inspection department and its technicians/inspectors in the day-to-day execution of customer/departments requests for incoming inspection.
• Responsible for mentoring, conduct performance reviews, creating training plans and delivering training to technicians/inspectors. Consistently enforce employing compliance including attendance at training programs, and promptly report any non-compliance to the Quality & Compliance Manager and/or Sr. Staff.
• Communicates department objectives and metrics. Implements changes in production methods, tooling and equipment, space allocations, workforce utilization, production schedules, lines and other factors required to maintain or improve compliance with quality standards of existing products and to establish initial and continuing compliance with quality standards for new and/or redesigned products.
• Be the main point of contact Senior Staff, Product Development, Design Quality, Supplier Quality, DHR Release, Receipts Routing/Repack-Relabel and other departments for incoming inspection to ensure timely execution of needed activities for routings, inspection sheets, cross-reference requirements and back order demands as required.
• Provides input to Incoming Inspection reports, requirements and other information in response to requests for proposals, quotes and other business opportunities. Provides input to budget planning process. Utilizes cost control initiatives to reduce expenses. Makes recommendations to management regarding ways to improve manufacturing processes and increase product quality and delivery while reducing production costs.
• Responsible for good housekeeping and safety procedures in the inspection areas.
• Alerts the organization to issues in time to resolve potential adverse effects on the customer, company image, or reputation of the business. Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state distribution processes.
• Reports on management reviews. Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
• Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
• Conduct periodic line audits to assess for production controls such as lot segregation. Conducts investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
• Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in the distribution site.
• Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
• Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
• Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements
• Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support. Develop, interpret and/or implement standard and non-standard sampling plans; and supports LEAN, JJOS and Six Sigma Initiatives.
• Proficiency in the English language is required.
• A minimum of a Bachelor’s Degree or equivalent is required, preferably in Engineering or related technical field.
• A minimum of six (6) years’ professional experience, including a minimum of four (4) years in a GMP, FDA and/or ISO regulated industry is required.
• A minimum of four (4) years’ experience with direct people management and/or project management experience is required.
• Knowledge of product/process Risk Management (FDA and ISO standards) is required.
• Ability to perform "hands on" troubleshooting and problem solving is required.
• Experience working in a European regulatory environment is preferred.
• Experience working in manufacturing/operations is preferred.
• Medical Device industry experience is preferred.
• Advanced Technical Training and experience using Statistics, Lean and Six Sigma Methodologies is preferred, including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• Knowledge of statistical software packages (Minitab) is preferred, with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
• Technical understanding of manufacturing equipment and distribution processes is preferred.
• Understanding of the NPI process and Process Validation expertise is preferred.
• Experience with MRP / ERP systems, preferred.
• JD Edwards or SAP software experience preferred
• This position requires up to 10% travel (domestic and/or international).
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
DePuy Synthes Products, Inc (6149)