Operations Quality Manager

Calqulate; Marlborough (MA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive base salary

10% annual target bonus

Comprehensive health, vision, and dent

Comprehensive health, vision, and dent

401(k) retirement plan with company-m‌

Job summary

Calqulate is seeking an experienced Operations Quality Manager in Eastern Massachusetts to lead day-to-day manufacturing quality operations and manage Quality Engineering and QC supervision teams. The role drives continuous improvement across production and ensures regulatory compliance.

The candidate will oversee NCR/MRB, CAPA, NPI quality planning, and cross-functional collaboration with Manufacturing, R&D, and Supply Chain while delivering data-driven KPIs to executive leadership.

Qualifications

• Education: Bachelor's degree in Engineering (Mechanical, Electrical, or related discipline) or equivalent professional experience.
• Experience: 8+ years in quality within regulated manufacturing (Medical Device, IVD, Aerospace, or Defense).
• Leadership: 3+ years directly managing Quality Engineers and/or QC teams.
• Technical: Deep shop-floor quality ownership, NCR/MRB systems, ISO 13485 / risk-based quality principles.
• Travel: Able to travel 5–10% for supplier visits, customer sites, and system testing.

Responsibilities

• Lead manufacturing-related quality activities, ensuring product compliance and high operational standards.
• Direct and mentor Quality Engineers, QC Supervisors, and inspection personnel to foster a strong culture of quality.
• Oversee in-process inspections, final product acceptance, and lot release activities.
• Own NCR and MRB processes, including investigations, dispositions, and root cause analysis.
• Drive CAPA and implement Lean/Six Sigma to improve yield, reduce risk, and boost efficiency.
• Support new product and manufacturing process introductions through quality planning.
• Maintain compliance with ISO 13485, FDA QMSR, and international medical device regulations.
• Represent manufacturing quality during internal and external audits.
• Collaborate with Manufacturing, R&D/Engineering, and Supply Chain to resolve quality challenges.
• Provide data-driven reports on quality KPIs, risk trends, and systemic improvements.

Skills

Quality Leadership

Team Management

NCR/MRB ownership

CAPA & Lean Six Sigma

Regulatory Compliance

Cross-Functional Collaboration

Data-driven reporting

Education

Bachelor's degree in Engineering or related field

Tools

ISO 13485

FDA QMSR

Job description

• Industry: Medical Devices / Healthcare Technology
• Experience Level: Mid-Senior (8+ Years)
• Job Function: Engineering / Quality Management
• Education Level: Bachelor's Degree or Equivalent
• Location: Greater Boston Area / Eastern Massachusetts
• Relocation Assistance: No
• Compensation: Competitive Salary + 10% Annual Target Bonus

Position Overview

We are seeking an experienced Operations Quality Manager to join a leading medical device manufacturing organization in Eastern Massachusetts.

This leadership role is responsible for overseeing day-to-day manufacturing quality operations, managing the Quality Engineering and QC Supervision teams, and driving continuous improvement initiatives across production.

Key Responsibilities

• Quality Leadership: Lead all manufacturing-related quality activities, ensuring product compliance and high operational standards.
• Team Management: Direct and mentor Quality Engineers, QC Supervisors, and inspection personnel to foster a strong culture of quality.
• Inspection & Release: Oversee in-process inspections, final product acceptance, and lot release activities.
• NCR & MRB Management: Own non-conformance (NCR) and Material Review Board (MRB) processes, including investigations, dispositions, and root cause analysis.
• CAPA & Continuous Improvement: Drive corrective actions (CAPA) and implement Lean/Six Sigma methodologies to improve process yield, reduce risk, and boost efficiency.
• NPI & Quality Planning: Support new product and manufacturing process introductions through risk management and quality planning.
• Regulatory Compliance: Maintain strict compliance with ISO 13485, FDA QMSR, and international medical device regulations.
• Audit Support: Represent manufacturing quality during internal and external regulatory/notified body audits.
• Cross-Functional Collaboration: Partner with Manufacturing, R&D/Engineering, and Supply Chain to resolve quality challenges and monitor vendor material performance.
• Reporting: Provide executive leadership with data-driven reports on quality KPIs, risk trends, and systemic improvements.

Must-Have Qualifications

• Education: Bachelor's degree in Engineering (Mechanical, Electrical, or related discipline) or equivalent professional experience.
• Experience: 8+ years of progressive Quality experience within regulated manufacturing (Medical Device, IVD, Aerospace, or Defense), with direct medical device industry experience required.
• Leadership: 3+ years of experience directly managing Quality Engineers and/or QC teams.
• Technical Expertise: Deep experience owning shop-floor quality, NCR/MRB systems, and ISO 13485 / risk-based quality principles.
• Travel: Ability to travel 5–10% for supplier visits, customer sites, and system testing.

Benefits Package

• Competitive base salary
• 10% annual performance bonus
• Comprehensive health, vision, and dental insurance
• 401(k) retirement plan with company match
• Life insurance coverage
• Generous paid time off (PTO) and leave options
• Flexible working environment