Job Description
COMPANY OVERVIEW
Merrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard. We are a growing manufacturing company that will play a crucial part in bringing innovative and life changing products to life. POSITION OVERVIEW
The Training Program Lead is responsible for the development, implementation, administration, and continuous improvement of the company's training system within a medical device Quality Management System (QMS) compliant with ISO 13485.
This role ensures all training activities are effectively planned, delivered, documented, and maintained in compliance with regulatory and internal requirements. The Training Program Lead oversees onboarding training, role-based qualification training, and ongoing compliance training, as well as training records, curricula, and training content management. This position works cross-functionally with Quality, Human Resources, Manufacturing, Engineering and Regulatory Affairs to ensure workforce competency and training compliance. RESPONSIBILITIES
Own and manage the company's training program within the QMS in compliance with ISO 13485 and applicable regulatory requirements. Ensure training processes, procedures, and records meet internal and external audit expectations. Maintain the integrity, accuracy, and completeness of training records within the electronic QMS or learning management system (LMS). Ensure compliance with training documentation requirements for regulatory inspections and audits. Develop, coordinate, and manage onboarding training programs for new employees. Responsible for administering trainings as needed. Ensure timely completion of required onboarding training assignments. Coordinate role-based training requirements in collaboration with department managers. Support qualification and competency tracking for job-specific training requirements Assign, track, and monitor employee training completion and compliance status. Maintain accurate and up-to-date training matrices and curricula. Ensure timely documentation of training completion, including attendance records and assessments. Generate training compliance reports, metrics, and dashboards for management review. Ensure training system alignment with ISO 13485, FDA QSR
(21 CFR Part 820), and other applicable regulatory requirements. Support internal and external audits by providing training records, reports, and compliance evidence. Identify gaps in training compliance and implement corrective actions as needed. Continuously improve training processes, tools, and systems to increase efficiency and effectiveness. Support implementation of new or updated processes through training rollouts. Work with HR to ensure alignment of onboarding and training processes with organizational requirements. Develop and maintain training KPIs, including training completion rates, overdue training, and compliance trends. Provide regular training compliance reports to management. Support management review activities with training system performance data. Conduct quarterly training documentation review ensuring compliance within ISO 13485 and internal procedures. QUALIFICATIONS AND SKILLS
Experience managing training systems, LMS platforms, or QMS training modules strongly preferred. Working knowledge of ISO 13485 and FDA QSR requirements related to training and competency. Prior experience providing informal leadership, coordination, or oversight of junior staff preferred. Strong understanding of training system requirements in a regulated environment. Excellent organizational and documentation management skills. Ability to manage multiple training programs and deadlines simultaneously. Strong attention to detail and compliance mindset. Experience developing or maintaining training content and materials. Strong communication and facilitation skills. Proficiency in Microsoft Office and learning management or QMS systems. Ability to work cross-functionally and influence training compliance across departments. Demonstrates strong presentation skills and the ability to deliver effective training. ISO 13485 or GMP training experience preferred. Instructional design or training development certification is a plus. ASQ certifications (CQA, CQIA, or similar) are an advantage. EDUCATION
Associate or Bachelor's degree in Quality, Education, Life Sciences, Engineering, or related field preferred. 2-5 years of experience in training coordination, quality systems, or regulated industry environment (medical device preferred). ibKiChFBVM
