Plant Manager

integralife; Añasco (PR); On-site; USD 156,000 - 219,000; Full time

Job summary

Integra LifeSciences in the United States seeks a Sr. Director, Plant Manager to lead safety, quality, and manufacturing operations at our medical device site.

You will drive strategy, policy, and capital planning while ensuring regulatory compliance with FDA QSR, ISO 13485, and other standards. This role partners with QA, Regulatory Affairs, and senior leadership to deliver safety, quality, delivery, and cost KPIs, oversee cross-functional teams, and foster a culture of continuous improvement

Qualifications

• A bachelor’s degree preferably in Engineering or related discipline with 15+ years leading a team or equivalent experience.
• Master’s degree with 10+ years of leadership experience or equivalent.
• Excellent organizational and English communication skills (oral & written).
• Financial acumen relating to operations profit & loss 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 across all levels of the organization.

Responsibilities

• Ensure safety of all colleagues and maintain a culture of safety and compliance.
• Foster engagement through leadership, career development, accountability, and feedback.
• Collaborate cross-functionally to solve operational issues with senior management.
• Lead quality culture and ensure compliance with FDA QSR, GMP, ISO 13485, and related standards.
• Oversee robust defect processing and validated state compliance (IQOQPQTMV).
• Drive continuous improvement to enhance reliability, throughput, and cost effectiveness.
• Develop strategies to meet site productivity and service targets using lean six sigma tools.
• Own budget management and alignment of resources with strategic priorities.

Skills

Leadership

Communication

Financial acumen

MS Office

Statistical analysis

Education

Bachelor’s in Engineering

Master’s in Engineering

Tools

SAP ERP

CRM platforms

MS Project

Jira

QMS platforms

Job description

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.

SUMMARY

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.

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.

QUALIFICATIONS

• A bachelor’s degree preferably in Engineering or a related discipline plus 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.

TOOLS AND EQUIPMENT USED

This role requires regular use of tools and equipment relevant to the work environment. Examples include:

• General office equipment: Computers, printers, copiers, fax machines, and telephone communication systems.

• Software and systems: ERP systems (e.g., SAP), CRM platforms, statistical analysis tools, project management software (e.g., MS Project, Jira), QMS platforms.

PHYSICAL REQUIREMENTS

The physical requirements listed below represent the motor and physical abilities necessary to successfully perform the essential duties of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to enable individuals with disabilities to perform these duties.

While performing the responsibilities of this role, the employee is expected to:

• Sit, listen, speak, and move throughout various areas of the building.

• Travel across all company locations as needed.

• Periodically lift and/or move items up to twenty-five pounds.

• Travel domestically and internationally via car, train, or airplane, as required by the role.

ADVERSE WORKING CONDITIONS

The conditions listed below represent environmental factors which the employee may be exposed to while performing the essential duties of this position. These reflect a general plant or service environment.

Adverse exposure may include handling hazardous and biohazardous materials such as:

• Flammable and corrosive liquids

• Compressed gases

• Sharps

• Medical waste

Appropriate safety protocols and personal protective equipment (PPE) are required and provided. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role.

Salary Pay Range:

$156,000.00 - $219,000.00 USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at [e-mail].

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

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