Quality Control Supervisor

Innovative Health LLC; Scottsdale (AZ); On-site; USD 75,000 - 95,000; Full time

Job summary

Innovative Health LLC is seeking a Quality Supervisor to plan and oversee reprocessing activities within the Quality Control department. You will ensure compliance with quality systems and regulatory requirements across all stages of inspections and materials handling.

The role focuses on staffing, training, KPIs, and overtime management, while driving continuous improvement initiatives and supporting audits. Experience with 21 CFR 820, ISO 13485, and ERP systems is essential.

Qualifications

• Bachelor's Degree in Life Science preferred or Associate with 2–5 years quality experience in medical devices.
• Strong supervisory experience (1–2 years).
• Experience with 21 CFR 820, ISO 13485 and Quality Systems is desirable.

Responsibilities

• Plans and supervises reprocessing QC activities in compliance with quality systems and regulatory requirements.
• Manages daily QC needs: staff tasks, training, productivity, KPIs, overtime approvals.
• Creates and enforces procedures for inspection, testing, identification, handling and storage of reprocessed products and materials.
• Drives quality improvement initiatives (e.g., Kaizen, Six Sigma) to enhance product line performance.
• Supports internal and external audits and reports quality trends and losses to management.
• Oversees inspections across incoming, in-process, finished goods and post-sterilization stages.
• Ensures proper labeling, storage, and handling to prevent mix-ups throughout the facility.
• Maintains MRB processes and material status updates in the ERP system.
• Establishes metrics (process capability, control charts) to monitor system effectiveness.

Skills

Quality supervision

Regulatory compliance

Process improvement

Documentation & records

Education

Bachelor's Degree in Life Science

Tools

J.D. Edwards ERP

Job description

Plans and supervises all reprocessing activities within the Quality Control department, concerned with the development, application, and maintenance of quality standards of manufacturing processes, raw materials, and finished products. 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:

• Ensures the activities of the department remain in compliance with quality system and regulatory requirements.
• Oversees the daily quality control needs including: setting staff tasks, staffing levels, ensuring training requirements, productivity requirements, Key Performance Indicators (KPIs), hours worked, and approval of overtime.
• Creates/Revises, implements, and enforces Quality procedures for inspection, testing, identification, segregation, handling, and storage of reprocessed product and the raw materials/components to support such processes.
• Initiates and implements quality improvement activities as appropriate (e.g., Kaizen, Six Sigma) to raise the performance of the company's product lines.
• Supports and/or participates in company internal and external audits.
• Reports to management on quality issues, trends and losses.
• Responsible for all phases of inspections supporting production (incoming, in-process, finished goods, and post-sterilization.
• Responsible for appropriate labeling, storage and handling of product and materials throughout the manufacturing facility to prevent mix-ups.
• Responsible for ensuring Quarantine areas are orderly maintained and scrapping requests made by the corporate 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.
• Establishes and implements metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound product quality decisions.
• Assist with nonconforming product investigations, CAPAs, and customer complaints.
• Interfaces with supplier and customer quality representatives concerning problems with Quality and assure that effective corrective action is implemented.
• All other reasonable duties, as assigned.

This position supervises Quality inspectors and is responsible for the performance, management, and hiring of the Quality Inspectors within the Quality department.

Education, Qualifications and Skills:

• Bachelor's Degree in Life Science is preferred or Associates degree with a minimum of 2 to 5 years Quality experience in the Medical Device industry; or equivalent combination of education and experience
• 1 to 2 years of Supervisory experience is strongly desired
• Experience with 21CFR820, Quality Systems Regulation and ISO 13495 strongly desired.
• 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.
• Must be proficient 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.
• Knowledge and experience with labeling standards and practices is desirable.
• Strong verbal, written, organizational, time management and interpersonal skills.