Hybrid Quality Leader Medical Device Manufacturing

Spectrum Staffing Services; Denville (NJ); Hybrid; USD 120.000 - 170.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision coverage

FSA

401(k)

Paid time off

Life and disability insurance

Bonus program eligibility

Zusammenfassung

Spectrum Staffing Services is seeking a hands-on Quality leader in New Jersey to strengthen quality systems, develop a high-performing team, and support reliable manufacturing execution. This role blends strategic leadership with floor-level engagement, partnering across operations, engineering, supply chain, and technical teams to improve controls and promote continuous improvement.

The successful candidate will own manufacturing quality activities, drive CAPA, ensure audit readiness, and

Qualifikationen

• Minimum 7 years of quality experience in medical device manufacturing.
• At least 3 years of team leadership or supervisory experience.
• Hands-on experience with quality systems, CAPA, investigations and product release.
• Knowledge of ISO 13485, FDA 21 CFR Part 820/QMSR, and ISO 14971.
• Ability to translate quality requirements into practical manufacturing processes.

Aufgaben

• Lead, coach, and develop Quality team members with clear priorities.
• Provide day-to-day Quality leadership for manufacturing operations.
• Oversee manufacturing quality systems and ensure integration across operations.
• Ensure quality requirements for incoming materials, in-process, and finished product release.
• Strengthen controls, sampling, acceptance criteria, and documentation.
• Collaborate on process validation, equipment qualification, calibration, and changes.
• Lead investigations on nonconformances, deviations, complaints, and recurring issues.
• Own CAPA activities, prioritization, and timely closure.
• Use metrics and trends to improve process control and right-first-time performance.
• Support supplier quality, audits, and corrective actions.
• Lead or support internal audits, management reviews, and document control.
• Promote Lean and continuous improvement to reduce variation.
• Maintain readiness for audits, inspections, and regulatory actions.
• Communicate performance and priorities to staff and leadership.

Kenntnisse

Leadership

Cross-functional communication

Problem-solving

Change-management

Floor-based quality leadership

Training and development

Data-driven decision making

Ausbildung

Bachelor's degree in science/engineering or related

Master's degree preferred

Tools

Microsoft Office

ASQ certification

Quality management systems (QMS)

Jobbeschreibung

Spectrum Staffing Services is seeking a hands-on Quality leader in New Jersey to strengthen quality systems, develop a high-performing team, and support reliable manufacturing execution. This role blends strategic leadership with floor-level engagement, partnering across operations, engineering, supply chain, and technical teams to improve controls and promote continuous improvement.

The successful candidate will own manufacturing quality activities, drive CAPA, ensure audit readiness, and