Quality Training Specialist (Onsite)

Position Overview:

The Quality Training Specialist plays an integral role in Insulet’s Training Department in a hands-on Trainer role responsible for training employees to current procedures, review and maintain quality records, oversee revision control of posted manufacturing documents, identify and update procedures as necessary, and provide training to those new procedures. The position requires strong organizational skills, oral and written communication skills, attention to detail, ability to work in cross functional teams, and drive to accomplish departmental and company goals. 

This position will have a shift that covers parts of 1st, 2nd, and 3rd shifts.

Responsibilities: 

• Delivers training to Insulet’s US Manufacturing Quality team, focusing on current deficiencies, procedural improvements, and operational efficiency through training.

• Document and report status of training; using organized record keeping practices.

• Train incoming assigned Employees to current procedures.

• Aid in updating training documents to reflect solutions for quality defects, safety issues or general operating inefficiencies within the quality processes and train employees to these new documents.

• Notifies Quality Supervisor or Quality Operations Manager of any discrepancies to ensure the highest training standards and safety of operations are always maintained.

• Interface directly with cross-functional departments to help drive training effectiveness.

• Partner with quality assurance engineers and other team members to ensure effective inspection and testing procedures are implemented and maintained.

• Review and maintain Quality records in support of the Quality System, e.g., training, internal audits, NCR, and CAPA

• Perform routine and ad hoc Reviews of manufacturing documentation, ensuring Good Documentation Practices (GDP) are followed.

• Review and post all manufacturing documentation ensuring proper revision control is maintained.

• Collect GDP and Revision control data and trend results.

• Perform other duties as assigned.

Education and Experience:

Minimum Requirements:

• Bachelors or equivalent experience.

• Minimum of 1 - 3 years’ experience in Medical Device manufacturing or cGMP regulated industry.

• Ability to present training course material to individuals and groups and to effectively facilitate their learning process.

• Ability to make decisions and work with minimal to moderate supervision.

Preferred Skills and Competencies:     

• Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.

• Excellent attention to detail, organization, and capable of working independently with minimal supervision from manager.

• Able to work in small groups and cross functional teams to maximize training effectiveness.

• Electrical and mechanical background strongly preferred.

• Prior experience working in a regulated industry (medical device) and/or experience working in a bio-hazard/lab environment preferred

• Preferred 2 years in a Quality related function, working with QSR and/or ISO 13485

• Computer proficiency in MS office (specifically Excel); experience creating and analyzing charts and Pareto charts a plus.

• Excellent technical writing skills

• Excels at generating and maintaining organized and accurate records.

• Experience with Lean Six Sigma methodology a plus

Physical Requirements (if applicable):         

• Required to stand for at least 75% of working time per shift, with walking at least 50% of working time per shift.

• Required to reach above shoulder freque