Job Title: SR QC Lab Supervisor

Email resume to: dfarrand @actalentservices.com

Job Description

The SR Incoming QC Lab Supervisor is tasked with overseeing all quality control activities pertaining to the verification of requirements for incoming, in-process, and finished goods. This role ensures compliance with company procedures, work instructions, and inspection plans. The supervisor is also responsible for the training and effective resource utilization of the QC staff. Advanced knowledge of mechanical inspections, processes, equipment, GD&T, calibrations, and blueprint reading is essential.

Responsibilities

• Perform and manage receiving inspections.
• Conduct mechanical inspections and utilize equipment, GD&T, and blueprint reading.
• Develop complex QC inspection methods.
• Exhibit superior QC technical skills.
• Operate measuring tools such as calipers, micrometers, or height and dial gauges.
• Utilize vision systems such as Micro-VU or Keyence.
• Lead and guide staff to ensure compliance with the company quality management system.
• Lead cross-functional efforts to resolve product performance issues and implement corrective actions to update SOPs and training materials.
• Support the Material Review Board in executing approved dispositions of NCR material.
• Ensure department staff are technically capable and appropriately trained for their assigned inspection responsibilities.
• Manage QC production deadlines and schedules.
• Lead assigned CAPAs to successful completion.
• Create QC validation protocols and reports.
• Perform other duties as assigned.

Essential Skills

• Bachelor’s degree or equivalent combination of education and experience.
• Minimum of twelve years progressive Quality experience within a GMP QC lab setting.
• Minimum of two years previous supervisory experience.
• Previous experience within a regulated medical device manufacturing or In-Vitro Diagnostic Device environment.
• Previous Quality Assurance experience within a 21 CFR Part 820 regulated environment.
• Strong written, verbal, and presentation skills.
• Strong planning, organizational, and time management skills.
• Ability to prioritize department duties including urgent matters.
• Competence in interpreting requirements and applying standard quality control practices.
• Clear understanding of GMP & GDP.
• Ability to train and mentor staff in complex inspection/verification methodologies.
• Strong understanding of process, gage, and equipment validation requirements.
• Experience with ERP systems such as SAP.
• Computer literacy with good working knowledge of Microsoft Office programs.

Additional Skills & Qualifications

• Med device/diagnostic experience is ideal.
• Strong leadership and communication skills.
• Experience with calibration and troubleshooting, micrometer, blueprint, inspection, and leadership.
• Experience in in vitro diagnostics, IVD, test methods, CAPA, validation, and ERP.

Work Environment

This role requires comfort with working with blood. The position operates on a 1st shift schedule from Monday to Friday, 7 AM to 4 PM. The company offers a rewarding work environment focused on people's health, maintaining a work/life balance with minimal weekend work. Employees enjoy 8-12 holidays off depending on the year, 15 PTO/sick days, and 3 floater holidays. The company provides an 8% 401K match, opportunities for mentoring, and a 15% bonus that typically gets paid out, prorated in the first year.

Job Type & Location

This is a Permanent position based out of San Diego, California.