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Open nowFirst seen 34 hours ago

Operations Quality Manager

Calqulate23 open roles

Where
Marlborough, Massachusetts, United States
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Your applicationOpen nowOperations Quality ManagerCalqulate · Marlborough, Massachusetts, United States

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Share of postings closed within
  1. 2.0%1 day
  2. 4.3%3 days
  3. 11.5%7 days
  4. 18.1%14 days
  5. 35.6%30 days
  6. 44.6%60 days
This job: first seen 34 hours ago

The posting

  • 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
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