Quality Compliance Associate Manager

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 Quality Compliance Associate Manager 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.

DUTIES & RESPONSIBILITIES

• Initiates and executes an effective and efficient change control process in accordance to internal procedures 

• Defines policies and standards across QMS procedures, work instructions, and forms and system governance

• Lead, facilitate, and mentor teams through all stages of the change control and training process

• Leads and participates in quality system improvement initiatives  and change control for the Israel site.

• Interface between functions /departments such as Design, Quality and Operations in product, process, system, or supplier related changes

• Act as an SME across compliance programs and change control and work cross functionally as needed

• 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 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

• Serves as the site process owner for Change Control, Documentation and Training.

• Establishes governance frameworks and performance objectives.

• Accountable for compliance performance and associated quality risks.

• 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 

EXPERIENCE AND EDUCATION

 Required 

• 8+ Years of related work experience in Quality Systems within a Medical Device or a highly regulated organization 

• Hands‑on experience revising and maintaining QMS procedures and work instructions, preferably in a software medical device environment

• 5+ 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 

• Fluent in Hebrew and English

Preferred 

• University/Bachelor’s Degree or Equivalent in Science/Engineering

• Lead Auditor/Auditor certification

• CQA/CQE certification from the American Society for Quality (ASQ) 

• Strong communication skills 

• Solid analytical and problem-solving skills and ability to deal with complexity

• Process and Detail oriented with a 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.