Operations Quality Manager at Calqulate in Marlborough, Massachusetts, United States

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
• 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.

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.

Requirements

• 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.

Skills

Required

• Quality management
• Manufacturing quality operations
• NCR/MRB systems
• ISO 13485
• Risk-based quality principles
• CAPA
• Lean/Six Sigma
• Audit support
• Data-driven reporting
• Cross-functional collaboration

Benefits

• 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