Quality Engineer

The Quality Engineer is responsible for developing, implementing, and maintaining quality plans, metrics, processes, and systems to ensure Azenta Life Science products consistently meet the highest standards of reliability, performance, and regulatory compliance.

This role serves as a technical quality leader, driving root‑cause analysis, corrective and preventive actions, and continuous improvement initiatives across the product lifecycle. The Quality Engineer works cross‑functionally with Manufacturing, Engineering, Service, New Product Introduction (NPI), Suppliers, and Customer Management teams to ensure quality requirements are achieved and sustained.

Success in this role requires strong analytical capability, deep knowledge of quality methodologies, and the ability to influence stakeholders without direct authority in a fast‑paced environment.

Key Responsibilities and Focus Areas

Quality Engineering & Product Support

• Own and resolve quality‑related issues within manufacturing, including internal, supplier, customer, and warranty issues
• Perform root cause analysis and define robust corrective and preventive actions (CAPA)
• Collaborate with internal and external stakeholders to resolve quality issues rapidly while maintaining compliance and safety standards
• Support escalation and containment activities, including production stops for nonconforming products or processes
• Write and maintain product test procedures and inspection methodologies
• Support first article/first off sample approvals

Process Control, Auditing & Compliance

• Conduct product and process audits to ensure compliance with internal procedures and regulatory requirements
• Ensure control plans, risk files, and associated documentation are implemented, maintained, and effective
• Support adherence to the Quality Management System (QMS), including ISO 13485 / ISO 9001 requirements
• Lead or participate in internal, supplier, and customer audits
• Maintain high standards of quality documentation through detailed reviews and approvals

Continuous Improvement & Metrics

• Monitor, analyze, and report on quality KPIs, including scrap, rework, and PPM performance
• Analyze trends and develop preventive actions to reduce non‑conformities
• Promote the use of continuous improvement methodologies such as:
  • Six Sigma
  • Poka‑Yoke (Error Proofing)
  • Measurement System Analysis (MSA)
  • Statistical Process Control (SPC)
• Actively contribute to continuous improvement projects and operational excellence initiatives

Supplier & Customer Quality

• Support management of supplier quality performance, including:
  • Supplier PPM
  • On‑time problem solving
  • Cost of Poor Quality (COPQ) and cost recovery
  • Supplier warranty indicators
• Participate in supplier issue resolution and improvement planning
• Interface directly with customers on quality issues, investigations, and corrective actions

New Product Introduction (NPI) & Risk Management

• Participate in cross‑functional teams supporting new product development and product changes
• Contribute to the creation and refinement of:
  • Design FMEA
  • Process FMEA
• Ensure product quality requirements are understood and embedded early in the design and manufacturing processes

Reporting, Communication & Technical Leadership

• Prepare written quality reports and present findings at project and customer meetings
• Plan and manage quality activities so progress can be tracked and communicated effectively
• Provide technical guidance and mentoring to peers and junior engineers
• Support quality awareness and training initiatives across the organization
• Independently determine technical approach and prioritize assigned tasks within strategic objectives

Education, Background & Qualifications

Required

• Bachelor’s degree in Engineering or related technical discipline
  or equivalent professional experience supporting electro‑mechanical products
• Demonstrated expertise in statistical tools and methods, including:
  • DOE
  • Hypothesis Testing
  • ANOVA
  • Gauge R&R
  • SPC
  • Capability Analysis
  • Weibull Analysis
• Experience analyzing large data sets and working with semi‑normalized databases
• Ability to translate data analysis into clear, actionable, business‑level recommendations
• Proficiency in:
  • Microsoft Excel, Word, PowerPoint, Access
  • Minitab
  • Tableau
  • Oracle (or similar ERP systems)
  • Report writing tools
• Strong organizational, communication, and presentation skills
• Ability to manage multiple priorities in a fast‑paced environment

Preferred

• Experience working in Life Sciences or regulated manufacturing environments
• Familiarity with:
  • FDA 21 CFR Part 820
  • ISO 13485
  • FDA Class II medical devices
• Experience working with global, cross‑functional teams

Additional Requirements

• Willingness to travel up to 25%, both domestic and international
• Commitment to continuous professional development and technical growth

Azenta is an Equal Opportunity Employer. This company considers candidates regardless of race, color, age, religion, gender, sexual orientation, gender identity, national origin, disability or veteran status.