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Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
The Value Stream Manager is responsible for end-to-end performance of a medical device production value stream. Manufacturing team leader and owner of the VS — from acceptance of design transfers, through lifecycle management to final device shipment. Under direct supervisionof the Plant Managerthe Value Stream Manager will be responsible for implementing strategies and plans to meet short and long-term goals to achieve the highest standards of safety, quality, customer service, and productivity. He/She is responsible for all aspects of safety and security, manufacturing, engineering, quality, regulatory, and project management within the value stream as measured by safety, quality, delivery, and cost key performance indicators (KPI's). They ensure the production of medical products in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 9001, ISO 13485, EU MDR, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies.
SUPERVISION EXERCISED
Position willdirectly manageoperationstechnicians, operators, supervisors,and process engineers.
KEY RESPONSIBILITIES
Ensures the safety of colleagues through effective and continuously improving environmental, health, and safety program engagement. Ensure all team members receive training, and are knowledgeable and compliantregardingsafety procedures, policies, permits, practices, PPE, proper housekeeping, and awareness. Initiates andleadaccident, near miss, and incident event notifications.
Lead, coach, and develop a team of supervisors and managers. Responsible for managing staffing,trainingand daily maintenance operations across shifts up to 7 days a week, including attendance, overtime, operational issues, talent management, performance management, developmentplanningand reporting of results. Interviews job candidates, completes performance reviews, and justifies promotions or disciplinary actions (asappropriate).
Serve as a member of the site leadership teamparticipatingin strategic and tactical planning & execution to ensure siteobjectivesare met. Ensure alignment of value streamobjectiveswith overall siteobjectives.
Foster a culture of colleague engagementthrupositive leadership, recognition, accountability, feedback, continuous improvement, and engagement activities
Responsible for the team’s compliance and meeting the quality standards as defined by Integra’s SOPs, GMPs, Global Quality Standards, local and procedures, where applicable. Partner with Quality Assurance and Regulatory Affairs to ensure full compliance with applicable standards (FDA QSR, GMP, ISO 13485,etc).
Initiate,developand implement engineering studies and IQ/OQ/PQ/TMV validations for equipment and processes to meet the demands of new product introductions and current manufacturing operations. Coordinate specific efforts as required by the project team. Includes such tasks as development of manufacturing process requirements, specifications, Failure Mode Effects Analysis (FMEA), validations, Engineering Change Requests/Orders (ECR/ECO)and Engineering Drawings.
Ensures investigations/CAPAs/nonconformancesidentifyroot cause, areappropriately corrected with sustainable remediations. Leverage data/tools/techniques toidentifyroot causes and implement sustainable corrective actions.
Ensure training and process documentation requirements are consistently met.
Partner with supplier quality and procurement to ensure supplier issues and changes are addressed appropriately within quality management systemin a timely manner.
Coach/mentorleansix-sigma manufacturing initiatives (5S, Kaizen, Value Stream Mapping, Kanban, Standard Work. OEE) to reduce waste and improve flow across the value stream.
Ensure teamsdeliveringmeasurable improvements in yield, throughput, and cycle time across the value streams in line with KPI targets.
Partner with the cross-functional teams to meet customer fulfillment needs as well as lead process optimization, yield improvement, six sigma process excellence and lean projects. Monitor process capability and performance metrics (CoPQ,Cpk, yield, run time, downtime, scrap). Develop process/project improvement and mitigation projects to improve capability and performance.
Develops, reviews, approves, and accountable for all financial budgets within the value stream, including headcount, expense, capital, and inventory.
Ensure value stream cost of goods sold (COGS) results are in line with financial targets by ensuring bill-of-materials (BOMS), routers, and process instructions align to costs.
Work cross-functionally and collaboratively to solve operational issues. Interacts with senior management on matters concerning several job areas, departments, and/or customers to accept new concepts,practicesand approaches as well as with senior levelvendoror customer representatives concerning projects & operational decisions.
Complete other job-related duties as assigned.
Skills & Competencies
Demonstrate excellent organizational andenglishcommunication skills (oral & written)
Financial acumen relating tooperations profit & loss (P&L) items
Proficiencyin MS Office Suite and statistical analysis software.
Experience in regulated environment; medical device or pharma preferred
Familiarity with health, safety, and environm
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