Plant Manager

Integra LifeSciences Corporation; California; Sur place; USD 125 000 - 173 000; Plein temps

Résumé du poste

Integra LifeSciences Corporation in California seeks a Plant Manager to lead safety, quality, and manufacturing excellence. You will own end-to-end value streams, drive continuous improvement, and ensure regulatory compliance with FDA QSR, ISO 13485, EU MDR and CMDR requirements.

The role requires strong leadership across operations, engineering, quality, supply chain, and finance to meet production, cost, and delivery goals while fostering a culture of safety and accountability.

Qualifications

• Engineering or technical degree with leadership experience in operations.
• Strong English communication skills (oral & written).
• Financial acumen related to operations P&L items.
• Proficiency with MS Office and statistical analysis software.
• Experience in regulated environments; medical device/pharma preferred.
• Familiarity with health, safety, and environmental regulations in manufacturing.
• Self-motivated, collaborative, able to work across levels of the organization.

Responsabilités

• Ensure safety of all colleagues and maintain a culture of safety and compliance.
• Lead site quality culture and ensure compliance with GMP/ISO standards.
• Oversee end-to-end value streams from procurement to shipment and drive improvements.
• Develop strategies to meet productivity, service targets, and budget controls.
• Lead continuous improvement using lean six sigma tools (5S, Kaizen, VSM, Kanban).
• Manage site financial performance, headcount, and capital investments.

Connaissances

Engineering/Technical degree

Leadership experience

English communication

P&L financial acumen

MS Office & statistics

Regulated environment exp

Health & safety regs familiarity

Teamwork / collaboration

Formation

Engineering or Technical degree

Master degree with 5+ years leadership

Description du poste

Changing lives. Building Careers.

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.

Plant Manager

The Plant Manager is responsible for developing and implementing strategies and plans to meet short and long-term goals to achieve the highest standards of safety, quality, customer service, and financials for the Integra Lifesciences' medical device manufacturing site.

They are responsible for all aspects of safety and security, manufacturing, engineering, supply chain, facilities, and oversight for site quality, regulatory, materials, procurement, finance, human resources, product development, distribution, and service as measured by safety, quality, delivery, and cost key performance indicators (KPI's). In addition, this role leads the plant as the site Value Stream Manager, accountable for end-to-end performance, daily management, and continuous improvement across the site value streams. 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.

KEY RESPONSIBILITIES

• Responsible for ensuring the safety of all colleagues and fostering a culture of safety and compliance. Ensure environmental, health, and safety programs are compliant, effective, and continuously improving. Ensure accident, near miss, and incident events are managed appropriately and timely, teams are trained appropriately, and proper housekeeping is maintained.
• Foster a culture of colleague engagement thru positive leadership, recognition, career development, accountability, feedback, continuous improvement, and engagement activities.
• Lead the site in the continual pursuit of a stronger quality culture and a robust quality management system and ensure site's quality standards compliance as defined by Integra's SOPs, GMP, Global Quality Standards, local and procedures, etc. Partner with Quality Assurance and Regulatory Affairs to ensure full compliance with applicable standards (FDA QSR, GMP, ISO 13485, etc).
• Ensures robust defect processing including root cause and sustainable remediations. Ensure operations remain in controlled and validated state (IQOQPQTMV) and is full compliance with all local regulatory QMS procedures.
• Foster a continuous improvement culture to advance operational excellence and ensure sustained improvements in manufacturing reliability, throughput, and cost effectiveness.
• Develop strategies and plans to meet/beat site productivity and service targets leveraging lean six sigma tools and techniques (5S, Kaizen, Value Stream Mapping, Kanban, Standard Work. OEE) to reduce waste and improve operational efficiency.
• Lead the site as Value Stream Manager , driving end-to-end flow from suppliers through manufacturing to shipment; chair value stream daily/weekly tier meetings; own and improve SQDC metrics (safety, quality, delivery, cost); and align cross-functional teams (operations, engineering, quality, supply chain) on priorities, problem solving, and execution.
• Fully accountable to site's financial performance and budget management, including oversight of headcount, operational expenses, and capital investments. Ensure efficient allocation of resources and alignment of spending with strategic priorities.
• Develop strategies and plans to meet both short term attainment and fulfillment plans as well as long term capacity plans aligning to enterprise objectives while maintaining flexibility.
• Complete other job-related duties as assigned.

Skills & Competencies

• Engineering or Technical degree with 8+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience OR Master degree with 5+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience
• Demonstrate excellent organizational and english communication skills (oral & written)
• Financial acumen relating to operations profit & loss (P&L) items
• Proficiency in MS Office Suite and statistical analysis software.
• Experience in regulated environment; medical device or pharma preferred
• Familiarity with health, safety, and environmental regulations related to manufacturing.
• Experience in regulated environment; medical device or pharma preferred
• Self-motivated team player with ability to work independently and collaboratively across all levels of the organization.

Salary Pay Range:

• $125,350.00 - $172,500.00 USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors