Mfg. Training Supervisor

Terumo Cardiovascular Group; Elkton (MD); On-site; USD 73,000 - 110,000; Full time

Job summary

An established industry player is seeking a Manufacturing Training Supervisor to lead the development and execution of training programs for their manufacturing teams. This role is crucial in ensuring compliance with regulatory standards and enhancing the quality of training for personnel. The ideal candidate will be a proactive leader with a strong background in training development, particularly in regulated environments. Join a dynamic team where you can make a significant impact on the quality systems training while enjoying a competitive salary and comprehensive benefits package. If you are passionate about training and quality in the medical device field, this opportunity is perfect for you.

Benefits

Annual Bonus

Paid Vacation

Health Benefits

Dental Benefits

Vision Benefits

401(k) with Matching Contributions

Tuition Reimbursement

Employee Assistance Program

Qualifications

• Experience in developing training programs for medical device quality systems.
• Ability to manage multiple databases and maintain training records.

Responsibilities

• Develop and supervise a team of Manufacturing Trainers.
• Establish a compliant quality systems training program for Manufacturing.
• Oversee the proficiency qualification program for employees.

Skills

Technical Writing

Training Development

Communication Skills

Attention to Detail

ISO Standards Knowledge

Leadership

Organizational Skills

Education

2-Year Degree

4 Years Experience in Leadership

3 Years Training Experience

Tools

MS Office

Learning Management Systems (LMS)

Job description

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations.

Job Summary:

The Manufacturing Training Supervisor is responsible for participating in designing, developing, facilitating and executing training requirements for Terumo Medical Corporation’s (TMC) Manufacturing teams. The objective of this training is to ensure compliance with cGMP, quality, regulatory and enterprise/corporate business requirements. This includes the FDA’s Quality System Regulation/Current Good Manufacturing Practices (21 CFR 820) and ISO-13485:2016.

The Manufacturing Training Supervisor will work with key business SMEs to develop, facilitate and maintain appropriate training for Manufacturing facility personnel. The individual in this position must be a self-starter with experience in developing new and innovative business and medical device quality systems training programs from the conceptual stage. This includes developing and facilitating a training schedule, curriculum, on-the-job training / proficiency qualification programs, records system and process for continuous improvement.

Responsibilities:

• Develop and supervise a team of Manufacturing Trainers. Provide coaching for professional growth and career development.
• Establish an effective, efficient and compliant quality systems training program focused on the Manufacturing area.
• Work with functional heads to develop and deploy a role-based Quality System training curriculum and the operations training infrastructure.
• Work with external training material providers to define, develop, implement and evaluate the required training materials.
• Develop and maintain the foundational training components of onboarding new hires and train them on TMC Quality System policies and procedures.
• Oversee the proficiency qualification program to ensure all employees have appropriate training and maintain qualification in their roles.
• Work closely with Management and Engineering personnel to understand system and process changes.
• Develop a network of SMEs to create, review, evaluate and possibly deliver the required training content and materials.
• Work with SMEs to develop measures for determining and documenting training effectiveness measures.
• Utilize the TMC electronic QS training system and assist with the development of an efficient training records maintenance process.
• Support the TMC Quality Systems training program during internal and external audits.

Position Requirements:

• Strong computer knowledge (MS Office), technical writing skills and proofreading ability.
• Ability to shape a training program from conception.
• Ability to establish and maintain a structured training development process.
• Working knowledge of managing multiple databases and Learning Management Systems (LMS’s) for a medical device and/or pharma environment.
• Ability to clearly communicate (both verbal and written), and successfully influence, all levels of the organization.
• Strong proofreading skills and organizational skills, as well as exemplary attention to detail.
• Demonstrated initiative and ability to work independently while handling multiple tasks.
• Good theoretical knowledge of ISO standards (ISO 13485) and regulatory requirements (21 CFR 820).
• Proven ability to manage and motivate employees in a dynamic, evolving and growing business environment.
• Position typically requires a 2-year degree or 4 years experience in a leadership role in a manufacturing or training capacity.
• 2 years managing employees preferred.
• 3 years minimum training experience in a regulated industry.

It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information, or any other category protected by law.

Final compensation packages will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. Rate of pay: $73,000 - $110,000/year.