MANAGER, MANUFACTURING QUALITY

Aspire Talent Solutions; Budd Lake (NJ); On-site; USD 120,000 - 170,000; Full time

Job summary

Aspire Talent Solutions is seeking a Manager, Manufacturing Quality for a medical instrumentation manufacturer. The role is a hands-on leader who strengthens quality culture, develops people, and partners across Operations, Engineering, and Supply Chain to ensure reliable execution and continuous improvement.

You will own and advance the manufacturing quality system, lead quality teams on the floor, drive CAPA and investigations, ensure compliance with ISO 13485, FDA 21 CFR 820, and ISO 14971,

Qualifications

• Bachelor's degree in science, engineering, or related field required.
• 7+ years in a medical device manufacturing environment.
• 3+ years of team leadership/supervisory experience.
• Proficient in ISO 13485, FDA 21 CFR 820, and ISO 14971 risk management.
• ASQ certifications a plus.

Responsibilities

• Lead and advance the manufacturing quality system.
• Provide day-to-day quality leadership for manufacturing operations.
• Develop and coach quality team members.
• Partner with Operations, Engineering, and Supply Chain.
• Oversee CAPA, investigations, and product releases.

Skills

Quality leadership

CAPA investigations

Root cause analysis

Regulatory compliance

GMP/ISO knowledge

Education

Bachelor's degree

Master's degree preferred

Tools

Microsoft Office

QMS software

Job description

Hiring company is a manufacturer of medical instrumentation. The Manager, Manufacturing Quality is a visible, hands‑on leader who builds a strong quality and compliance culture, develops people, strengthens manufacturing controls, and partners across Operations, Engineering, and Supply Chain. This role offers the opportunity to shape how quality enables reliable execution, continuous improvement, customer confidence, and sustainable growth. The position will own and advance the manufacturing quality system, including leading and development of quality team members. Lead, coach, and develop Quality team members through clear priorities, regular feedback, effective delegation, and meaningful growth opportunities. Provide day‑to‑day Quality leadership for manufacturing operations, including floor presence, escalation support, disposition decisions, QMS training, and timely resolution of production issues.

Education and/or Experience:

• Bachelor's Degree in science, engineering, or related field is required. Master's degree preferred.
• Minimum 7 years of related experience in a medical device manufacturing environment required.
• Minimum 3 years’ team leadership/supervisory experience required.
• Demonstrated experience with manufacturing quality systems, nonconformance, CAPA, investigations, root cause analysis, product release, audits, supplier quality, and validation or qualification activities required.
• Must possess working knowledge of applicable quality system standards and requirements, such as ISO 13485, FDA 21 CFR 820 (QMSR), and ISO 14971 risk management principles and the ability to apply requirements in a practical manufacturing environment.
• Proficiency with Microsoft Office applications and the ability to learn and use quality and manufacturing systems.
• ASQ certifications a plus.
• 10% travel. Must be able to travel both domestically and possibly internationally.