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.
What You’ll Be Doing
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
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