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Quality Operations Manager

BioTalent
Taunton, MA Full Time
POSTED ON 12/23/2025
AVAILABLE BEFORE 1/21/2026

Role Overview

The Operations Quality Manager leads quality execution across multiple manufacturing, assembly, distribution, and laboratory environments, including support for new product introductions and global product transfers. This role is responsible for driving consistent quality performance, strengthening processes, and ensuring products meet internal and external requirements throughout their lifecycle.

The position oversees quality planning and project execution across several operational functions, using data-driven analysis to identify trends, address risks, and improve both product and process outcomes. This leader plays a critical role in advancing continuous improvement efforts and supporting high levels of customer satisfaction.

Key Responsibilities

  • Lead and allocate quality resources across manufacturing, assembly, kitting, distribution, laboratory, and calibration functions
  • Oversee quality activities related to new product introductions and global manufacturing transfers
  • Drive investigation and resolution of product quality issues, deviations, and nonconformances
  • Establish, monitor, and report key quality performance metrics
  • Lead corrective and preventive action initiatives and continuous improvement projects
  • Set annual objectives, performance expectations, and development plans for team members
  • Partner cross-functionally with engineering, R&D, supply chain, and external manufacturing partners to resolve quality issues
  • Promote and implement best practices to improve process robustness and operational effectiveness

Qualifications

  • Bachelor’s degree in Engineering or a scientific discipline; advanced degree preferred
  • 5 years of experience in quality operations or a related technical field
  • 2 years of experience leading or managing teams
  • Strong working knowledge of corrective and preventive action systems and internal auditing
  • Experience with regulated quality management systems (e.g., ISO-based standards)
  • Familiarity with risk management, process capability, product qualification, and new product development
  • Proven ability to lead change and implement continuous improvement methodologies
  • Strong leadership, communication, and stakeholder engagement skills
  • Ability to operate independently across multiple teams and functional areas
  • Solid technical writing and documentation review capabilities

Salary : $130,000 - $160,000

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