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Quality Engineer

Job in Bedford, Middlesex County, Massachusetts, 01730, USA
Listing for: Actalent
Full Time position
Listed on 2026-10-09
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering, Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Control - QC Analysts/Managers
Salary/Wage Range or Industry Benchmark: 100000 - 130000 USD Yearly USD 100000.00 130000.00 YEAR
Job Description & How to Apply Below

Job Title:

Quality Engineer

Job Description

The Quality Engineer maintains and continuously improves the Quality Management System (QMS) in alignment with ISO 9001 and other applicable standards, driving consistent product and process quality across the organization. This role leads internal and external audits, ensures regulatory compliance, and uses data-driven analysis to identify and implement continuous improvement opportunities. The position offers a clear growth path toward leadership roles such as Quality Manager or Director of Quality for a self-directed professional who enjoys collaborating across all levels of the organization.

Responsibilities

  • Maintain, monitor, and continuously improve the Quality Management System (QMS) in accordance with ISO 9001 and other applicable standards.

  • Develop, revise, and control Quality Policies, Procedures, Work Instructions, Forms, and related quality documentation to ensure consistency and compliance.

  • Monitor QMS effectiveness using performance metrics, trend analysis, and continuous improvement initiatives, and recommend improvements based on findings.

  • Lead and coordinate external audits, including ISO surveillance and recertification audits, customer audits, and regulatory assessments.

  • Plan, conduct, and report internal quality audits to verify compliance with internal and external requirements.

  • Track audit findings, assign and follow up on corrective actions, and ensure timely and effective closure.

  • Maintain compliance with RoHS, Conflict Minerals, REACH, and other applicable regulatory requirements related to products and processes.

  • Prepare quality performance reports and present quality metrics and trends during Management Review meetings.

  • Analyze quality data to identify recurring issues, root causes, and opportunities for process and product improvement.

  • Support risk assessment and mitigation activities across the organization to reduce quality-related risks and improve robustness.

  • Support quality requirements for new product introductions, engineering changes, and process changes to ensure compliance and smooth implementation.

  • Participate in company improvement initiatives and special projects as assigned by the Head of Quality or quality leadership.

  • Apply root cause analysis and problem-solving methodologies to resolve quality issues and prevent recurrence.

  • Collaborate with cross-functional teams to promote quality best practices and ensure alignment with organizational goals.

  • Work independently with minimal supervision while effectively managing multiple quality projects and priorities.

Essential Skills

  • Strong knowledge of ISO 9001 requirements and quality management principles.

  • Hands-on experience with quality engineering and Quality Management Systems (QMS).

  • Proficiency in root cause analysis and structured problem-solving methods.

  • Working knowledge of Lean Manufacturing and Six Sigma methodologies.

  • Familiarity with ERP or MRP systems.

  • Proficiency with Microsoft Office applications, including Excel, Word, PowerPoint, and Visio.

  • Ability to analyze data and generate actionable quality metrics and reports.

  • Ability to interpret mechanical drawings, including Geometric Dimensioning and Tolerancing (GD&T).

  • Excellent written, verbal, and presentation skills for communicating quality information at all levels.

  • Strong organizational and project management skills to handle multiple tasks and deadlines.

  • Demonstrated ability to influence and collaborate effectively across all levels of the organization.

  • Self-directed and capable of working with minimal supervision.

Additional Skills & Qualifications

  • Lean Six Sigma Green Belt or Black Belt certification preferred.

  • Epicor ERP experience is a plus.

  • Understanding of electrical schematics is a plus.

  • Experience working with regulatory requirements such as RoHS, Conflict Minerals, and REACH.

  • Experience preparing and presenting quality metrics for Management Review.

  • Experience in leading or supporting external and internal quality audits.

  • Interest in career growth toward Quality Manager or Director of Quality roles.

Work Environment

The Quality Engineer works in a structured manufacturing and engineering environment focused on maintaining a robust Quality Management System and complying with ISO 9001 and relevant regulatory standards. The role involves regular interaction with cross-functional teams, participation in audits, and use of ERP/MRP systems and Microsoft Office tools to manage data and documentation. The position emphasizes continuous improvement, Lean and…

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