Site Operations Leader

**Essential Duties and Responsibilities**:

- **Strategic Leadership**
- Full P&L accountability, targeting optimal financial and operational results.Drive strategic alignment with global business objectives, ensuring competitive advantage and market growth, including working with customers on enhancements and next generation products.
- **Operational Excellence and Compliance**:

- Ensure rigorous adherence to both ISO 13485 and ISO 9001 standards, managing comprehensive quality management systems.
- Champion continuous improvement initiatives across the site to enhance efficiency, reduce waste, and improve product and service quality.
- Conduct monthly KPI reviews, employing data-driven problem-solving methods to achieve targets.
- Ensure health and safety within the site including, compliance and trainingOverall responsibility for security protocols for precious metals including global compliance and integrity audits.
- **Team Management and Development**:

- Lead and develop a high-performing management team by driving a culture of professional growth, operational accountability, and self-improvement.Lead and own employee engagement and overall performance at the site through strong employee focused initiatives including, team building, social responsibility, community engagement and employee development
- **Quality Management and Regulatory Compliance**:

- Ensure continual compliance with all applicable local and international quality, regulatory, and customer requirements.
- Implement robust procedures to ensure operations are compliant and audit-ready under ISO 13485, ISO 9001, and other regulatory frameworks.Ensure strong partnership and collaboration with global quality stakeholders.

**Qualifications**:

- Bachelor’s degree in engineering, Business Administration, or related field, with a Master’s degree or MBA highly preferred.
- Extensive leadership experience within a manufacturing environment, particularly in the medical device industry, with a thorough understanding of ISO 13485 and ISO 9001.
- Strong background in continuous improvement, KPI management, problem-solving, capacity expansion projects, and financial analysis.
- Demonstrable experience in EHS management, precious metals security, and product development including cost analysis.Exceptional strategic, analytical, and communication skills, capable of leading complex operations and driving significant business results.

**Knowledge, Skills & Abilities**:

- Strong knowledge of manufacturing operations in the medical contract manufacturing domain, including a deep understanding of industry best practices, quality systems, and regulatory requirements
- Proven ability to lead and manage manufacturing operations, demonstrating a track record of achieving operational targets and driving continuous improvement.
- Excellent problem-solving and decision-making abilities, with the capacity to analyze complex situations, identify root causes, and develop effective solutions.
- Strong project management skills, with the ability to effectively plan, organize, and execute multiple projects simultaneously.
- Demonstrated ability to build and lead high-performing teams, fostering collaboration, open communication, and a positive work culture.
- Excellent interpersonal and communication skills, with the ability to effectively interact with individuals at all levels of the organization and across cross-functional teams.
- Strong leadership qualities, including the ability to inspire and motivate others, drive change, and influence stakeholders.
- Strategic mindset and business acumen, with the ability to identify opportunities for innovation, cost reduction, and long-term value creation.
- Ability to manage resources effectively, including budget, workforce, equipment, and materials, in order to achieve production targets and deliver results.