Job Description

Job Title: Quality Control Supervisor – Preanalytics

Location: North Carolina

Salary: $120k

The Quality Control Supervisor – Preanalytics (QCPA Supervisor) is responsible for overseeing the daily operations of the PreAnalytics Quality Control Laboratory. This role involves managing teams including Team Leads, Chemical Additive, and QC Inspectors. The QCPA Supervisor ensures compliance with internal quality policies and regulatory standards, and is accountable for the completion and quality of PreAnalytics products and their components.

Responsibilities:

• Provide leadership, supervision, and mentorship to direct-report teams.
• Track attendance and coordinate daily activities to meet departmental Key Performance Indicators (KPIs).
• Support and oversee quality validation activities.
• Ensure proper identification and handling of nonconforming products.
• Oversee the release of Incoming Goods Inspections according to established procedures.
• Review and approve half-finished and finished products in line with valid procedures.
• Complete required tasks in SAP, such as product transfers, reviews, quality holds, and releases.
• Organize and perform special testing in collaboration with Quality Control Management (QCM).
• Conduct training and retraining for quality control and production personnel.
• Prepare, edit, and distribute quality-related documents.
• Perform periodic inventory checks and order laboratory supplies as needed.
• Support the maintenance of laboratory and manufacturing testing equipment, including scheduling and performing internal/external calibrations as required.
• Assist with administrative tasks as assigned.
• Provide support for in-process inspections and incoming goods inspections as needed.
• Carry out additional duties as assigned.

Authority:

• Train new and existing quality control employees on QC procedures and equipment use.
• Perform release and scrap ERP transactions in accordance with established procedures.
• Evaluate products following valid procedures.
• Collaborate with QCM or designated personnel for review and corrections of related Quality Issue Reports (QIRs).

Job Requirements:

• Bachelor's Degree in Science, Life Sciences, or a related field (Bachelor's Degree preferred).
• A minimum of 3 years of relevant leadership experience in a medical device or similar manufacturing environment (ISO 13485 experience preferred).
• At least 2 years of work experience in a Quality Control laboratory setting, including Good Manufacturing Practice (GMP), Good Documentation Practice (GDP), and Good Laboratory Practice (GLP).
• Advanced experience with laboratory testing equipment, instrumentation, analysis, and laboratory data processing and review.
• Intermediate-level experience with Computer Aided Quality (CAQ) inspection systems.
• Proficiency in MS Office and data management systems.
• Knowledge of basic statistics and chemical calculations is required; advanced chemical calculation proficiency is preferred.

Physical Requirements:

• Ability to stand and walk for 8-12 hours.
• Ability to lift up to 70 lbs.
• Vision acuity sufficient to perform detailed quality inspections as per Standard Operating Procedures (SOPs) or Technical Procedures (TPs)