Quality Engineer in Manchester

Azenta UK, Ltd. is driven by new ideas, technologies, and ways of thinking. Our customer-focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships. All we accomplish is grounded in our core values of Customer Focus, Achievement, Accountability, Teamwork, Employee Value, and Integrity.

Responsibilities

• 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

• 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.

If any applicant is unable to complete an application or respond to a job opening because of a disability, please email recruiting@azenta.com for assistance. 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.