Operations Quality Manager

Calqulate•Marlborough, MA

1d•Onsite

About The Position

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.

Requirements

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

Responsibilities

Lead all 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 non-conformance (NCR) and Material Review Board (MRB) processes, including investigations, dispositions, and root cause analysis.
Drive corrective actions (CAPA) and implement Lean/Six Sigma methodologies to improve process yield, reduce risk, and boost efficiency.
Support new product and manufacturing process introductions through risk management and quality planning.
Maintain strict compliance with ISO 13485, FDA QMSR, and international medical device regulations.
Represent manufacturing quality during internal and external regulatory/notified body audits.
Partner with Manufacturing, R&D/Engineering, and Supply Chain to resolve quality challenges and monitor vendor material performance.
Provide executive leadership with data-driven reports on quality KPIs, risk trends, and systemic improvements.