Integra LifeSciences Corporation
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Quality Control Specialist
at Integra LifeSciences Corporation
- Vacancy ID
- Position Type
- Regular Full-Time
- Quality Assurance
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The Quality Control Specialist plays a key role in the success of site Quality Systems and compliance activities. The Quality Control Specialist is responsible for closely partnering with recovery, processing, customer service and distribution to support the compliant receiving and inspection of recovered tissue and supplies. Additionally, the Quality Control Specialist will support the inspection and disposition of returns of both local and third-party products. The Quality Control Specialist will perform the inspections in a timely manner and in compliance with the standard operating procedures. The Quality Control Specialist plays a key role in the execution of the organization’s Quality System and assists in continuous improvement of the Quality System.
- Administrative duties include but are not limited to the completion of the receiving, inspection and returns processes related to tissue recovery, donor records, supplies, internal and vendor quality control, product returns including third party, and quality assurance documentation
- Coordinate and participate in the tissue recovery procedure by performing related Quality inspection steps on documentation and process
- Serve as meeting coordinator on Quality control activities such as tissue recovery and supplies receiving and inspection
- Review and inspect Donor record documentation
- Documenting Vendor Quality Control issues and statuses
- Execute all Quality Inspection Return process activities on local product and third-party product
- Monitor the effectiveness of the Quality System
- Trend Quality Control metrics and present defined reports at specified intervals
- Facilitate Good Documentation Practices
- Participate in review meetings with Quality team on site SOP creation and revision
- Support site audit procedures for internal and external audits.
- Uphold regulatory guidelines set forth by the FDA, AATB, HHS, and OSHA
- Other Quality department duties as assigned
- Bachelor’s degree, specialization in science, engineering, or related technical field preferred or minimum 3 years of experience working within an FDA regulated industry (e.g., Medical Device, Pharmaceutical, HCT/P).
- Understanding of 21 CFR 820 and/or 1271, ISO 13485, AATB Standards, and ISO 14971 preferred.
- Self-motivator with an analytic nature.
- Strong organizational, communication, and interpersonal skills.
- Must have experience working in MS Office Software Suite, and ERP/MRP management software experience is a plus.
- Ability to obtain Quality training and/or certifications as needed.