Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
This Change Control Analyst is responsible for implementation and execution of documentation, change control, and training processes based on business, regulatory and customer requirements to ensure compliance with company and regulatory requirements.

EXPERIENCE AND EDUCATION

Required

• 3+ Years of related work experience, including experience in Quality Systems, Information Technology for a Medical Device or a highly regulated organization
• 3+ years of experience in document management or using an electronic document management system
• Experience working with business applications, not limited to GxP computer applications, such as Agile, TrackWise, is preferred
• Proficient in Microsoft Office Applications, Adobe Acrobat, and database application

Preferred

• University/Bachelors Degree or Equivalent in Science/Engineering or Business Administration.
• CQA/CQE certification from the American Society for Quality (ASQ)
• Solid interpersonal skills
• Solid analytical and problem-solving skills
• Solid communications skills
• Process and Detail oriented and focus in accuracy
• Ability to work in a fast-paced environment and rapidly shifting priorities,
• Ability to quickly adapt and navigate different applications and computer software
• Solid presentation skills
• Ability to communicate with multiple levels of management.

Unsolicited Agency Submission
Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails

• Initiates and executes an effective and efficient change control process in accordance to internal procedures
• Lead, facilitate, and mentor teams through all stages of the change control and training process
• Leads and participates in quality system improvement initiatives
• Interface between functions /departments such as Design, Quality and Operations in product, process, system, or supplier related changes
• Have responsibility for initiation of changes, assessment of the change impact and routing of all tasks, with attention to detail, for completeness, accuracy, effectivity and appropriateness
• Liaise with Change Requester and SMEs during all stages of the Change Control process, including Training process
• Reviews all changes for ensuring sound rationale, challenging justification, correct approval, alignment and oversight
• Monitoring completion of post release tasks to ensure completion in a timely manner
• Support and lead initiatives for continuous improvement
• Participate in project teams for change control
• Support in training needs related to the change control process
• Manages periodic review process and procedures in applicable PLM Systems.
• Support in the preparation, participate, and address issues related to document and change management for internal and external (FDA, BSI, etc.) audits as needed
• Investigates and resolves non-conformances, audit observations, corrective and preventive actions (CAPAs) related to Change control and training process
• Assists in the creation and development of metrics to evaluate the effectiveness and efficiency of Change Control Processes
• May support onboarding training for new employees; collaborate with managers to align onboarding content with role-specific needs.
• Monitor training completion, generate compliance reports, and collaborate with stakeholders to ensure compliance.
• Performs other duties assigned as needed