Senior Technical Quality Supervisor

Main Responsibilities

• Provide daily leadership, supervision, work direction, and on-the-job training to engineers, technicians, and inspectors, fostering a high-performing and engaged team environment.
• Develop and maintain a competent workforce through effective recruitment, coaching, communication, recognition, performance management and employee development.
• Monitor, prioritize, and allocate departmental resources and workloads to ensure internal customer requirements, schedules, and business objectives are achieved.
• Lead department operations while driving collaboration across cross-functional teams, including Quality, Manufacturing, Supply Chain, Engineering, and Regulatory Affairs, to support organizational goals.
• Build and maintain effective working relationships with external stakeholders, including suppliers, contract laboratories, auditors, and regulatory agencies, to ensure alignment with quality and compliance requirements.
• Ensure adherence to company policies, quality systems, and applicable regulatory standards, while monitoring compliance and driving continuous improvement initiatives.
• Contributes to establishing department goals, objectives and accountabilities.
• Recommends, justifies and acquires measurement equipment and supplies to meet department objectives.
• Monitor and improve the effectiveness of inspection and testing processes through data-driven decision-making and continuous improvement methodologies.
• Oversees and evaluates the effectiveness of inspection and testing procedures, driving enhancements to ensure quality, efficiency, and compliance.
• Leads, coaches, and motivates team members to achieve performance objectives while fostering a culture of accountability, engagement, and high performance.
• Promotes and sustains a department culture focused on continuous improvement, operational excellence, and customer satisfaction.
• Effectively communicate and collaborate with internal and external partners to resolve issues, manage risks, and achieve business objectives.
• Department's technical lead during audits, inspections, and quality system inquiries, providing expert guidance and support to ensure compliance and successful outcomes.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors.

Qualifications

• Bachelor's Degree (± 16 years) in Business or related field or an equivalent combination of education and work experience.
• Minimum 5 years experience in related experience, including supervision.
• Previous Quality inspection, technician or engineering experience required.
• Knowledge of FDA, GMP, and ISO 13485.
• Strong communication and leadership skills.
• Prior medical device experience preferred.
• ASQ certification or equivalent preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
• Ability to work effectively within a team in a fast-paced changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multi-tasks, prioritizes and meets deadlines in timely manner.
• Strong organizational, planning, and follow-up skills and ability to hold others accountable.
• Ability to travel approximately 25%, including internationally.