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 rootcause analysis corrective and preventive actions and continuous improvement initiatives across the product lifecycle. The Quality Engineer works crossfunctionally 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 fastpaced environment.

Key Responsibilities and Focus Areas

Quality Engineering & Product Support

• Own and resolve qualityrelated 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 nonconformities
• Promote the use of continuous improvement methodologies such as:
  • Six Sigma
  • PokaYoke (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
  • Ontime 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 crossfunctional 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

• Bachelors degree in Engineering or related technical discipline
  or equivalent professional experience supporting electromechanical 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 seminormalized databases
• Ability to translate data analysis into clear actionable businesslevel 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 fastpaced 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 crossfunctional 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.