Quality Director

Job Title: Director of Quality Control 

Position Summary

The Director of Quality Control (QC) is responsible for leading and standardizing QC operations across the organization with primary oversight of the Bethlehem (BTH) and Marquette (MQT) sites.

This role ensures that all inspection and testing activities are executed in compliance with internal requirements, customer expectations, and global regulatory standards. The Director serves as a key liaison with Quality Assurance (QA) to ensure that QC activities are aligned with risk, design intent, and control strategies.

The position is accountable for consistent execution, documentation accuracy, and operational efficiency of QC, while providing data-driven input to QA for decisions related to inspection strategy and optimization.

Key Responsibilities

QC Operations Leadership 

Direct all QC functions across BTH and MQT, including Incoming, in-process, final inspection

and the Calibration laboratories. Ensure QC activities are executed consistently, efficiently, and in compliance with procedures and specifications. Eliminate inspection-related bottlenecks impacting production flow (e.g., machine downtime due to paperwork or inspection delays). Drive standard work and accountability within QC teams.

QC–QA Liason

Act as the primary QC liaison to QA for BTH and MQT. Ensure QC execution aligns with Control plans, Risk management outputs, and Change control decisions. Provide data and operational insight to QA to support decisions on Inspection strategies, Sampling approaches, Process improvements. Support implementation of defined strategies within QC operations.

Inspection & Test Method Execution

Ensure all inspection and test methods are clearly defined, consistently executed, and properly executed. Oversee control of all inspection equipment including calibration, availability, automated inspection equipment program management (vision system, CMM etc). Ensure appropriate application of sampling plans and inspection criteria

Data, Performance & Accountability

Establish and monitor KPIs for QC performance, including documentation right-first-time completion, Inspection turnaround time, Production delays related to QC, and escapes. Drive root cause and corrective actions for inspection errors, execution failures, etc.

Regulatory & Audit Readiness

Ensure QC is in a constant state of audit readiness. Serve as QC SME during audits at BTH and MQT.

Ensure inspection records and DHRs are audit-ready, complete, and accurate.

Organization & Team Leadership

• Build and lead a disciplined QC organization across BTH and MQT
• Define clear roles, responsibilities, and expectations within QC
• Ensure proper staffing and capability to meet operational demands
• Identify gaps and escalate structured resource needs with clear justification
• Develop team capability in: 
  • Inspection methods
  • Documentation discipline
  • Problem-solving and accountability

Qualifications

Education & Experience

• Bachelor’s degree in Engineering, Quality, or related field
• 10+ years in Quality within medical device or regulated manufacturing
• 5+ years leading QC or inspection organizations, preferably across multiple sites

Technical Expertise

• Strong knowledge of: 
  • ISO 13485
  • FDA 21 CFR 820 / QMSR
  • Inspection and metrology practices
  • Risk based approach to inspection
• Experience with: 
  • MSA (Gage R&R, bias, linearity)
  • Sampling plans (ANSI/ASQ Z1.4, C=0)
  • Automated Inspection Equipment (Vision System, Comparator, CMM)