Plant Manager

Integra LifeSciences•US-PR-Anasco-165-Facility, PR

51d•$156,000 - $219,000•Onsite

About The Position

The Sr. Director, 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). 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.

Requirements

Engineering or Technical degree with 15+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience or master’s degree with 10+ 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.
Self-motivated team player with ability to work independently and collaboratively across all levels of the organization.

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 accidents, 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 through positive leadership, recognition, career development, accountability, feedback, continuous improvement, and engagement activities
Work cross-functionally and collaboratively to solve operational issues. Interacts internally and externally with executive level management, requiring negotiation of extremely critical matters. Negotiates with internal and external counterparts who may be unwilling to accept new concepts, practices and approaches or who have walkaway potential.
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.
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.