QC Inspector - 1st Shift
Innovative Health LLC
Summary
The QC Inspector performs sampling, inspection, testing, and sampling of incoming materials; conducts required in-process and final inspection of reprocessed devices their packaging; performs pre- and post-sterilization inspection of batches and review of Batch Production Records (BHRs). Strictly follows and enforces established procedures and policies needed to meet the demands of Quality in a regulated medical device company.
Job description
Essential Duties and Responsibilities
- Perform inspections of purchased components, reprocessed devices and their packaging, sterilization records, and Batch History Records (BHRs) to controlled procedures and pre-determined acceptance criteria.
- Accurately document the results of the inspections and testing.
- Participate in the creation and/or revision of procedures for the inspection function.
- Ensures appropriate labeling, storage and handling of product and materials throughout the manufacturing facility to prevent mix-ups.
- Ensures Quarantine areas are orderly maintained and scrapping requests made by the Materials Review Board (MRB) are fulfilled.
- Responsible for updating material status in ERP system following the completion of Quality activities.
- Ensures line clearance and material reconciliation activities are conducted as dictated by company procedures.
- Assist with nonconforming product investigations, CAPAs, and customer complaints.
- All other reasonable duties, as assigned.
Education, Qualifications and Skills
- High School Diploma or equivalent; 1-2 years of Quality Inspection experience is preferred.
- Must have good English written and verbal communication skills; Good arithmetic skills are required
- Mechanical aptitude and working knowledge of measure instruments is desired
- Experience with 21CFR820, Quality Systems Regulation and ISO 13495 a plus.
- Must demonstrate a high level of attention to detail in completion of tasks and cross-referencing of information in several locations.
- Must demonstrate the ability to multi-task and prioritize in a fast-paced environment, and possess flexibility when juggling numerous projects simultaneously.
- General proficiency in Microsoft Word and other applications (Excel, PowerPoint, Adobe Acrobat, and Visio).
- Experience with J.D. Edwards ERP software use a plus.
- Must grasp instructions and information rapidly and apply them with little supervision self-motivated, self-starter.
- Strong verbal, written, organizational, time management and interpersonal skills.
Requirements
- High School Diploma or equivalent
- 1-2 years of Quality Inspection experience preferred
- Good English written and verbal communication skills
- Good arithmetic skills
- Mechanical aptitude and working knowledge of measurement instruments desired
- Experience with 21CFR820, Quality Systems Regulation and ISO 13495 a plus
- High level of attention to detail
- Ability to multi-task and prioritize in a fast-paced environment
- Proficiency in Microsoft Word, Excel, PowerPoint, Adobe Acrobat, and Visio
- Experience with J.D. Edwards ERP software a plus
- Self-motivated, self-starter
- Strong verbal, written, organizational, time management and interpersonal skills
Company overview
Innovative Health LLC is an advanced, FDA-regulated medical device reprocessing company specializing in electrophysiology and cardiology devices. Founded in 2015 by reprocessing industry pioneers, the company focuses on developing innovative technologies to safely reprocess single-use medical devices used in cardiac procedures. Based in Scottsdale, Arizona, Innovative Health has established itself as a leader in the medical device reprocessing sector with over 50 FDA clearances for reprocessing complex electrophysiology devices. The company's core mission is to help hospitals and electrophysiology labs significantly reduce procedure costs by offering reprocessed single-use devices at substantially lower prices, enabling healthcare facilities to adopt newer technologies, improve patient care, and expand services. With a specialized focus on cardiology devices, including mapping catheters, diagnostic ultrasound catheters, and transseptal needles, Innovative Health employs advanced R&D capabilities and maintains collaborative partnerships with leading hospitals across the United States. The company's science-driven approach and guaranteed savings programs have positioned it as a key player in addressing healthcare cost challenges while maintaining patient safety and regulatory compliance.