Job Details

Senior Supervisor, Quality Control - Incoming Mechanical Inspection

Job Summary: The Senior Incoming QC Lab Supervisor is responsible for overseeing all QC activities related to verification of requirements of incoming, in-process, and finished good materials, ensuring compliance with company procedures, work instructions and inspection plans, and directing the QC staff to execute all required tasks. They are responsible for staff training and resource utilization and should have advanced knowledge of mechanical inspections, processes, equipment, GD&T, and blueprint reading.

Responsibilities

• Experience with receiving inspections.
• Mechanical inspections, processes, equipment, GD&T, and blueprint reading.
• Ability to develop complex QC inspection methods.
• Superior QC technical skills.
• Experience with measuring tools such as calipers, micrometers, or height and dial gauges.
• Experience with vision systems such as micro-VU or Keyence.
• Ability to lead and guide staff to ensure compliance with the company quality management system.
• Lead cross-functional efforts to resolve product performance issues and lead corrective actions to update SOPs and training materials.
• Support the Material Review Board in the execution of approved dispositions of NCR material.
• Ensure department staff are technically capable and appropriately trained for their inspection responsibilities.
• Manage QC production deadlines and schedules.
• Lead assigned CAPAs to successful completion.
• Creation of QC validation protocols and reports.
• Other duties as assigned.

Qualifications

• Bachelor's degree or equivalent combination of education and experience required.
• A minimum of twelve (12) years of progressive Quality experience within a GMP QC lab setting required.
• A minimum of two (2) years of previous supervisory experience required.
• Previous experience within a regulated medical device manufacturing or In-Vitro Diagnostic Device (IVDD) environment strongly preferred.
• Previous Quality Assurance experience within a 21 CFR Part 820 and ISO 13485 regulated environment required.

Skills & Capabilities

• Strong written, verbal, and presentation skills.
• Strong planning, organizational, and time management skills; ability to prioritize duties including urgent matters.
• Demonstrated competence with interpreting requirements and applying standard quality control practices and methodologies to determine material acceptability.
• Clear understanding of ISO 13485, GMP, and 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) preferred.
• Computer literacy and good working knowledge of Microsoft Office programs.

Education, Certifications and Experience

• Travel Requirements: Less than 5%.

Job Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance
• Industries: Medical Equipment Manufacturing