QC Inspector - 2nd Shift

Innovative Health LLC; Scottsdale (AZ); On-site; USD 42,000 - 60,000; Full time

Job summary

Innovative Health is seeking a 2nd shift QC Inspector to join our growing team. 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).

Training will occur on 1st shift 6:00am-2:30pm for about 2 months.

Qualifications

• High School Diploma or equivalent; 1-2 years of Quality Inspection experience preferred.
• Must have good English written and verbal communication skills; Good arithmetic skills.
• 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.
• Must demonstrate the ability to multi-task and prioritize in a fast-paced environment; flexibility with multiple projects.

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.
• Ensure appropriate labeling, storage and handling of product and materials throughout the facility.
• Maintain orderly Quarantine areas and process scrapping requests from MRB.
• Update material status in the ERP system following Quality activities.
• Ensure line clearance and material reconciliation per procedures.
• Assist with nonconforming product investigations, CAPAs, and customer complaints.
• All other reasonable duties as assigned.

Skills

English proficiency

Attention to detail

Multitasking

Mechanical aptitude

Arithmetic skills

Documentation

Interpersonal skills

Education

High School Diploma or equivalent

Tools

J.D. Edwards ERP

Microsoft Word

Excel

PowerPoint

Adobe Acrobat

Visio

Job description

Innovative Health is seeking a 2nd shift QC Inspector to join our growing team. Our Operations team 2nd shift schedule is Monday - Friday 2:00pm - 10:00pm with the opportunity for overtime on the weekends. Training will be on 1st shift from 6:00am - 2:30pm for approximately 2 months.

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.

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.