Job Description

This position performs senior-level quality control functions, overseeing comprehensive quality management responsibilities within a manufacturing environment. Duties include maintaining certifications, managing customer complaints, conducting inspections, programming inspection equipment, and supporting audits. The role requires deep technical expertise and knowledge in specialized functions to support the development of policies, procedures, and innovative approaches for achieving strategic business goals.

Responsibilities:

The tasks listed below are representative of this role and not intended to cover every possible assignment. Management may assign additional functions as deemed appropriate.

• Oversee, schedule, and prioritize all inspection activities, including First Article Inspections (FAIs) and Coordinate Measuring Machine (CMM) programming
• Track, document, and trend customer complaints, non-conformances, and Corrective and Preventive Actions (CAPAs)
• Lead process validations, special requirements capability studies, Gage Repeatability and Reproducibility (Gage R&R), and statistical analyses as required
• Maintain and manage quality system documentation, including procedures, forms, and work instructions; ensure ongoing compliance with ISO 13485
• Oversee calibration programs and ensure proper gage calibration
• Manage Engineering Change Orders (ECOs), customer-driven revisions, and disposition of Work-in-Process (WIP) and inventory items
• Authorize the Material Review Board (MRB) for disposition decisions
• Perform part inspections and sort customer products as needed
• Coordinate internal and external audits; host customer audits as necessary
• Perform administrative Human Resources (HR) tasks using a Human Resources Information System (HRIS)

Required Experience:

• Associates degree or technical certificate in programming, process engineering, or related field
• 8+ years of experience in quality control, including 3 years in a supervisory role
• Required or must obtain: Lean certification, Black Belt training, and GD&T (Geometric Dimensioning & Tolerancing) certification

Knowledge, Skills, and Abilities

• Expertise in engineering principles and geometric dimensions and tolerances
• Proficient in the use of measurement tools: calipers, micrometers, depth gauges, indicators, and Go/No Go gauges
• Working knowledge of ISO 13485 and FDA 21 CFR Part 820 standards (training provided if needed)
• Strong computer skills, including Microsoft Office (Word, Outlook, Excel), Adobe PDF, SolidWorks, In-Spec metrology software, and ERP systems
• Proficient in mathematics including geometry, algebra, and metrics for specification calculations
• Skilled in prioritizing and managing multiple projects to meet quality and customer goals
• Capable of maintaining performance under pressure and adapting to change
• Strong analytical and problem-solving skills using root cause analysis and CAPA development
• Effective delegation, organization, and motivational abilities
• Ability to establish positive working relationships across departments
• Clear and effective communicator in English, both written and verbal