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.

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