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The Senior Quality Compliance Specialist -Training will create and conduct training programs to enhance the skills and competencies of employees in a medical device-regulated environment.  The Senior Training Specialist will assess training needs, develop curriculum, and deliver training sessions to improve workplace performance and align with Integra’s core values. The Senior Training Specialist will collaborate with various stakeholders to identify training gaps and develop targeted solutions to address them. They will also be responsible for evaluating the effectiveness of training programs and make necessary adjustments to ensure continuous improvement. Additionally, the Senior Training Specialist will create and maintain standard on-boarding protocols for new hires to streamline the process.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Primary responsibilities are to:

• Building annual, biannual, quarterly, etc. training programs and preparing training plans, with subject matter experts, that adhere to GDP and GMP standards.

• Identifying training needs by periodically evaluating ongoing programs to ensure that they reflect any changes or have opportunities to be improved.

• Translating requirements into training plans and maintaining training matrices with each of the groups to ensure both compliance and business needs can be met, including appropriate levels of cross-training.

• Creating and maintaining standard onboarding protocols for new hires to streamline the process and ensure consistency across Operations and the greater site.  This would include but is not limited to GMP 101 training, site tours and overviews, and ensuring new hires are set up for success.

• Acclimating new hires to the business and conducting orientation sessions in partnership with Quality and Environment Health & Safety.

• Assessing training effectiveness to ensure incorporation of taught skills and techniques into employees work behavior.

• Working with Document Control and platform leads to review document curriculums and ensure they are mapped to the appropriate associate.

• Working with Document Control Team, Quality, and Manufacturing Engineering to ensure awareness of procedural changes and when they are released.

• Responsible for effectively interacting with all levels of associates and all functional departments within the organization.

• Develop and provide site training metrics to Monthly Metrics Review Boards, Quarterly Management Reviews and Site Leadership. 

• This role may be audit facing for training.

• Effectively works in a team setting, supports team goals and objectives.

• Delivering training courses as necessary and coaching others in delivering training courses.

• Use tools to create professional audio-visual course trainings.

• Other activities as assigned.

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• Bachelor’s degree in Engineering, Life Science, or a related field with 5+ years' experience in QA/Compliance within the medical device or similar industry or equivalent education and years of experience

• On-site position in Boston, MA with transition to a brand-new state of the art facility in Braintree, MA in 2025.

• Adequate knowledge of learning management software.

• Experience in GMP and quality systems regulations (FDA QSRs, ISO 13485:2016, CFR 820).

• Proven experience in designing multiple training events in a manufacturing setting.

• Knowledge of Microsoft Office software applications including Microsoft Excel.  Ability to develop charts and trend data.

• Knowledge of instructional design theory and learning principles.

• Effective communication skills, both written and verbal.

• Superior organizational skills and demonstrated ability to perform multiple tasks.

• Ability to work independently with minimal supervision.

• Ability to present complex information to a variety of audiences.

• Experience with FDA and/or Notified Body audits/inspections preferred.

• Ability to communicate effectively (both written and oral) using English.

• Demonstrated ability to work cross-functionally in a team environment .

• Proficient with the MS Office Suite.

• Must be able to observe company policies and safety procedures at all times.

TOOLS AND EQUIPMENT USED

Ability to utilize a computer, telephone, smart phone as well as other general office equipment. Strong computer skills are required including software applications such as Agile, Oracle and Learning Management Systems.

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include, but are not limited to, the motor/physical abilities and skills required of position in order to successfully undertake the essential duties and responsibilities of this position.  In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, and speak. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 50 pounds.