Senior Quality Engineer

STERIS; Roma; On-site; EUR 35,000 - 45,000; Full time

Benefits offered by this job

Corporate bonus

Equal Opportunity Employer

Job summary

STERIS is seeking a Senior Quality Engineer to manage and drive the quality system improvements, supplier quality actions, and data-driven decisions across manufacturing operations. The role emphasizes leadership in corrective actions, audits, and cross-functional collaboration to deliver product quality enhancements.

The position requires extensive experience in ISO-regulated environments, strong analytical skills, and the ability to lead quality initiatives that impact both process and product

Qualifications

• Minimum of 5 years of related Manufacturing/Quality Engineering and/or Quality Systems experience, with strong supplier quality experience.
• Experience in an ISO-certified environment; medical device or another regulated industry is preferred.
• Experience with supplier qualification and audits, SCAR/CAPA, root-cause investigation, risk management, and supplier performance improvement.
• ASQ, QSR or familiarity with QSR/GMP regulations

Responsibilities

• Serves as the Core Team Member on cross-functional new product/service development teams with focus on the execution of quality plans and design/service transfer.
• Develops and implements statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis in support of products and service improvements.
• Leads process and product corrective actions and problem-solving activities.
• Reviews the current quality system and recommend / implement improvements as needed.
• Uses data to perform statistical analysis and recommend process / product changes to improve product and service quality.
• Leads projects focused on quality system, product quality and service quality improvements.
• Develops analyses and reports on the performance of the quality system.
• Leads supplier audits and corrective actions.
• Leads and supports internal and external quality system audits.
• Instructs other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
• Collaborates with other departments and facilities within the company on quality related issues.
• Supervises Quality Engineers and other Quality staff in the execution of their assigned duties and objectives.
• Maintains product integrity and quality through the evaluation and disposition of nonconforming materials and processes.
• Perform all other duties as assigned.

Skills

Quality engineering

Supplier quality

Statistical methods

Cross-functional collaboration

Process improvement

Quality systems

Education

Bachelor's Degree in Engineering

Job description

Position Summary

The Senior Quality Engineer is responsible for managing processes and leading projects to maintain and improve the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820/211, EU MDR and other applicable standards. This role leads complaint/CAPA investigations, supplier quality improvement actions, operations production and process control improvements, and product and service quality improvements with the use of statistical techniques and other accepted quality principles. This role plans and executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.

Duties

• Serves as the Core Team Member on cross-functional new product/service development teams with focus on the execution of quality plans and design/service transfer.


• Develops and implements statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis in support of products and service improvements.


• Leads process and product corrective actions and problem-solving activities.


• Reviews the current quality system and recommend / implement improvements as needed.


• Uses data to perform statistical analysis and recommend process / product changes to improve product and service quality.


• Leads projects focused on quality system, product quality and service quality improvements.


• Develops analyses and reports on the performance of the quality system.


• Leads supplier audits and corrective actions.


• Leads and supports internal and external quality system audits.


• Instructs other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.


• Collaborates with other departments and facilities within the company on quality related issues.


• Supervises Quality Engineers and other Quality staff in the execution of their assigned duties and objectives.


• Maintains product integrity and quality through the evaluation and disposition of nonconforming materials and processes.


• Perform all other duties as assigned.

Required Experience

• Minimum of 5 years of related Manufacturing/Quality Engineering and/or Quality Systems experience, with strong supplier quality experience.


• Experience in an ISO-certified environment; medical device or another regulated industry is preferred.


• Experience with supplier qualification and audits, SCAR/CAPA, root-cause investigation, risk management, and supplier performance improvement.


• ASQ, QSR or familiarity with QSR/GMP regulations

Education Degree

Bachelor's Degree in Engineering General

Key competencies

• Technical leadership and problem-solving


• Quality systems and continuous improvement


• Data-driven decision making and metrics analysis


• Technical documentation and process optimization


• Cross-functional collaboration and stakeholder management


• Coaching, mentoring, and knowledge sharing


• Effective communication and influencing skills


• Strong business acumen and strategic thinking


• Critical thinking and sound judgment in complex environments


• Ability to drive results with minimal supervision and high accountability.

Compensation

In line with our commitment to transparency and equal pay, we provide the following information:

• Salary Range: 35.000€ - 45.000€.


• NCBA: Chimica, Concia e settori accorpati, CONFAPI.


• This position is eligible for corporate bonus .

This position requires knowledge of English due to the nature of the duties involved, including regular communications outside the province of Quebec, training, email communications, and frequent meetings and interactions with English- only employees. The employer has taken all reasonable steps to avoid imposing this language requirement, in accordance with the Charter of the French Language.

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services around the globe. For more information, visit www.steris.com.

STERIS strives to be an Equal Opportunity Employer.