MANAGER, MANUFACTURING QUALITY

Calqulate; Budd Lake (NJ); On-site; USD 120,000 - 150,000; Full time

Job summary

Calqulate Metrics Ltd seeks a hands‑on Manager, Manufacturing Quality to lead our quality organization in a medical instrumentation environment. You will own the quality system, drive CAPA, investigations, and product releases, and partner with Operations, Engineering, and Supply Chain to sustain compliance and growth.

You will develop quality staff, ensure training, and provide floor support for manufacturing operations, with travel up to 10% to support audits and supplier quality activities.

Qualifications

• Bachelor's degree in science, engineering or related field required.
• Minimum 7 years of medical device manufacturing experience.
• Minimum 3 years’ supervisory experience.
• Experience with quality systems, nonconformance, CAPA and investigations.
• Knowledge of ISO 13485, FDA 21 CFR 820 and ISO 14971 is required.
• Proficiency with MS Office; ASQ certifications a plus.
• Travel up to 10% domestically or internationally.

Responsibilities

• Own and advance the manufacturing quality system.
• Provide day‑to‑day quality leadership for manufacturing operations.
• Lead, coach and develop Quality team members with clear priorities and growth opportunities.

Skills

Quality systems

CAPA

Investigations

Root cause analysis

Product release

Audits

Supplier quality

Validation/qualification

MS Office

Education

Bachelor's Degree in science, engineering, or related field

Master's degree preferred

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.