Specialist, Quality Compliance

Changing lives. Building Careers.

Joining us is a chance 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, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Quality Compliance Specialist will provide quality compliance support to the Collagen Manufacturing Center (CMC) Plant. This function shall participate in the development, review and/or approval of various Quality System Documentation to ensure that the development, manufacture and distribution of medical products are in compliance with company policies and procedures, US. Food and Drug Administration Regulations, ISO 9001, ISO 13485:2016 Standard, European Medical Device Directives, Canadian Medical Device Regulations, and other applicable regulatory agencies. Experience with assessing quality suppliers and purchasing specifications is a plus.

Essential Duties And Responsibilities

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

Review and approve quality documents requiring QA oversight (e.g., IOPQ and validation protocols, Engineering Change Orders (ECO), deviations, OOS/OOT reports, DHR, Supplier Quality Assessments, Supplier Corrective Action Reports (SCAR), alert and action reports, purchasing specifications, etc.)

Prepare and compile metrics for Quality Management Reviews

Serve as the quality compliance representative for project teams

• Participate on new product development project teams as quality compliance representative
• Support investigation of complaints, nonconforming raw materials, in-process product or finished goods as necessary
• Provide guidance for Product Development, Operations and Engineering teams on project development activities to ensure they conform to internal SOPs
• Identify and implement opportunities for continuous improvement, including document revisions in order to maintain accurate SOPs.
• Review product and process changes for impact on existing notification requirements, for conformance with Design Control regulations and standards, and internal Standard Operating Procedures
• Provide support in FDA inspections, ISO audits and customer audits at the CMC facility
  
  

Desired Minimum Qualifications

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

• Bachelor’s degree or higher in scientific, or related field.
• 3- 5 years experience in Quality.
• Excellent oral, written and presentation communication skills are required.
• High degree of attention to details and organization skills are required
• Must possess a team-focused attitude
• Demonstrated computer skills.
• Ability to work independently.
  
  

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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