About this role
Job Description
Provide leadership for the site's training and competency management system, ensuring associates are qualified, compliant, and prepared to support business objectives. Through the development of training strategies, certification programs, and workforce capability initiatives, drive operational readiness, talent development, and continuous improvement in a highly regulated manufacturing environment. Job duties:
- Provide direct leadership, coaching, performance management, and development for Training Supervisors, Training Leaders, tTainers, and other assigned personnel.
- Establish site training priorities and translate business, quality, and manufacturing needs into practical training and competency plans.
- Ensure training, qualification, certification, and recertification processes comply with the Quality Management System (QMS), applicable procedures, and regulatory requirements.
- Maintain clear role-based training requirements and ensure associates are qualified before performing work independently.
- Lead the design, implementation, and continuous improvement of curricula, learning paths, on-the-job training, qualification methods, and effectiveness assessments.
- Partner with Operations, Quality, Engineering, Regulatory, Human Resources, and other functions to identify capability gaps, evaluate risk, and implement effective solutions.
- Support new product introductions, technology transfers, process changes, production ramp-ups, and other site initiatives by developing timely training and certification strategies.
- Monitor training capacity, certification status, cross-training coverage, time to competency, compliance, effectiveness, and other workforce-readiness indicators; escalate risks and implement recovery plans.
- Ensure accurate, complete, and timely training records in the Learning Management System (LMS) and other approved systems.
- Serve as the primary training representative for audits, inspections, nonconformances, investigations, CAPAs, and remediation activities; provide objective evidence and ensure actions are completed on time.
- Apply Lean principles, structured problem solving, and data analysis to improve training quality, flow, standardization, efficiency, and resource utilization.
- Manage departmental staffing, schedules, workload, budget, vendors, equipment, training spaces, and other resources within approved limits.
- Prepare and present training performance, compliance status, workforce capability, risks, and improvement plans to site leadership.
- Promote a culture of accountability, learning, inclusion, quality, safety, and operational excellence.
- Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrated Ethics and Integrity in all matters and at all levels throughout the organization.
- Perform other related duties and special projects as assigned.
Qualifications
- Bachelor’s degree in engineering, Business Administration, or a related field.
- Minimum of three (3) years of experience in training, learning & development, manufacturing, quality systems, or a related function within a regulated industry.
- Minimum of three (3) years of leadership experience managing training professionals or cross-functional teams.
- Working understanding of regulatory requirements, including FDA 21 CFR Part 820, ISO 13485, ISO 9001, and Quality Management Systems, with experience ensuring compliance in highly regulated manufacturing environments.
- Proven experience supporting training compliance, competency management, audits, NCRs, CAPAs, and workforce readiness initiatives.
- Advanced knowledge of adult learning principles, instructional design, training effectiveness, and Learning Management Systems (LMS).
- Strong analytical, problem-solving, organizational, and decision-making skills, with the ability to leverage metrics and training ROI to drive business results.
- Excellent written and verbal communication, influencing, interpersonal, and stakeholder management skills.
- Written and verbal English proficiency (B2-C1).
- Proficient computer skills including MS Word, Excel, PowerPoint, Outlook, and Teams.
Desired Qualifications
- Proficiency with Learning Management Systems (LMS).
- Strong project management, prioritization, and organizational skills.
- Ability to work independently and collaborate effectively across functions.
- Experience optimizing training processes and resources to improve efficiency and business results.
- Proven ability to influence stakeholders and support organizational change.
- Lean Six Sigma, Lean Manufacturing, or other continuous improvement certification.
Physical
- Extended periods of computer use.
- Extended periods of sitting, walking, and standing.
- Ability to work in office, classroom, laboratory, and manufacturing environments.
- Extended periods of working in cleanrooms and controlled manufacturing environments, adhering to gowning, contamination control, and hygiene requirements.
- Personal Protective Equipment (PPE), such as gloves, safety glasses, gowns, masks, hearing protection, and safety footwear may be required in controlled environments.
- May be exposed to manufacturing equipment, moving machinery, and industrial environments requiring compliance with established Environmental Health & Safety (EHS) procedures.
- Ability to adjust work hours occasionally to support multiple shifts, audits, training events, or urgent business needs.
- May be required within the position to be in an environment that can include radiation exposure (such as in Cathlabs)