QC Inspector - 1st Shift

Innovative Health LLC; Scottsdale (AZ); On-site; USD 42,000 - 54,000; Full time

Job summary

Innovative Health LLC seeks a QC Inspector to perform sampling, inspection, testing, and packaging checks on incoming materials and reprocessed devices. The role includes pre- and post-sterilization inspection and review of Batch Production Records, ensuring strict adherence to procedures for a regulated medical device environment.

Applicants should have a high school diploma and 1–2 years quality inspection experience, strong English communication, and attention to detail.

Qualifications

• High School Diploma or equivalent; 1-2 years of Quality Inspection experience preferred.
• Good English written and verbal communication skills; good arithmetic skills required.
• Mechanical aptitude and working knowledge of measurement instruments desired.
• Experience with 21CFR820, Quality Systems Regulation and ISO 13495 a plus.
• Attention to detail in cross-referencing information across locations.
• Ability to multi-task in a fast-paced environment with flexibility across projects.
• Proficiency with Microsoft Word; familiarity with Excel, PowerPoint, Adobe Acrobat, Visio.
• Experience with ERP systems (JD Edwards) is a plus.
• Self-motivated, capable of working with minimal supervision.

Responsibilities

• Inspect purchased components, reprocessed devices and packaging against procedures and acceptance criteria.
• Document inspection and testing results accurately.
• Participate in creating/updating inspection procedures.
• Ensure proper labeling, storage, and handling of product and materials.
• Maintain orderly quarantine areas and process MRB scrapping requests.
• Update material status in ERP after quality activities.
• Ensure line clearance and material reconciliation per procedures.
• Assist with nonconforming product investigations, CAPAs, and customer complaints.
• Perform additional duties as assigned.

Skills

Communication skills

Arithmetic skills

Mechanical aptitude

Attention to detail

Multi-tasking

Self-motivation

Interpersonal skills

Time management

Organizational skills

Education

High School Diploma or equivalent

Quality Inspection experience (1-2 years)

Tools

Microsoft Word

Excel

PowerPoint

Adobe Acrobat

Visio

J.D. Edwards ERP

Job description

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.