Senior Quality Engineer
h3Position Summary /h3 /brpThe 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. /p /br /brh3Duties /h3 /brul /brliServes 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. /li /brliDevelops and implements statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis in support of products and service improvements. /li /brliLeads process and product corrective actions and problem-solving activities. /li /brliReviews the current quality system and recommend / implement improvements as needed. /li /brliUses data to perform statistical analysis and recommend process / product changes to improve product and service quality. /li /brliLeads projects focused on quality system, product quality and service quality improvements. /li /brliDevelops analyses and reports on the performance of the quality system. /li /brliLeads supplier audits and corrective actions.
/li /brliLeads and supports internal and external quality system audits. /li /brliInstructs other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques. /li /brliCollaborates with other departments and facilities within the company on quality related issues. /li /brliSupervises Quality Engineers and other Quality staff in the execution of their assigned duties and objectives. /li /brliMaintains product integrity and quality through the evaluation and disposition of nonconforming materials and processes. /li /brliPerform all other duties as assigned. /li /br /ul /br /brh3Required Experience /h3 /brul /brliMinimum of 5 years of related Manufacturing/Quality Engineering and/or Quality Systems experience, with strong supplier quality experience. /li /brliExperience in an ISO-certified environment; medical device or another regulated industry is preferred. /li /brliExperience with supplier qualification and audits, SCAR/CAPA, root-cause investigation, risk management, and supplier performance improvement. /li /brliASQ,
QSR or familiarity with QSR/GMP regulations /li /br /ul /br /brh3Education Degree /h3 /brpBachelor's Degree in Engineering General /p /br /brh3Key competencies /h3 /brul /brliTechnical leadership and problem-solving /li /brliQuality systems and continuous improvement /li /brliData-driven decision making and metrics analysis /li /brliTechnical documentation and process optimization /li /brliCross-functional collaboration and stakeholder management /li /brliCoaching, mentoring, and knowledge sharing /li /brliEffective communication and influencing skills /li /brliStrong business acumen and strategic thinking /li /brliCritical thinking and sound judgment in complex environments /li /brliAbility to drive results with minimal supervision and high accountability. /li /br /ul /br /brh3Compensation /h3 /brpIn line with our commitment to transparency and equal pay, we provide the following information: /p /brul /brliSalary Range: 35.000€ - 45.000€. /li /brliNCBA: Chimica, Concia e settori accorpati, CONFAPI. /li /brliThis position is eligible for corporate premio . /li /br /ul /br /brpThis 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. /p /br /brpSTERIS 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 /p /br /brpSTERIS strives to be an Equal Opportunity Employer. /p #J-18808-Ljbffr
/li /brliLeads and supports internal and external quality system audits. /li /brliInstructs other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques. /li /brliCollaborates with other departments and facilities within the company on quality related issues. /li /brliSupervises Quality Engineers and other Quality staff in the execution of their assigned duties and objectives. /li /brliMaintains product integrity and quality through the evaluation and disposition of nonconforming materials and processes. /li /brliPerform all other duties as assigned. /li /br /ul /br /brh3Required Experience /h3 /brul /brliMinimum of 5 years of related Manufacturing/Quality Engineering and/or Quality Systems experience, with strong supplier quality experience. /li /brliExperience in an ISO-certified environment; medical device or another regulated industry is preferred. /li /brliExperience with supplier qualification and audits, SCAR/CAPA, root-cause investigation, risk management, and supplier performance improvement. /li /brliASQ,
QSR or familiarity with QSR/GMP regulations /li /br /ul /br /brh3Education Degree /h3 /brpBachelor's Degree in Engineering General /p /br /brh3Key competencies /h3 /brul /brliTechnical leadership and problem-solving /li /brliQuality systems and continuous improvement /li /brliData-driven decision making and metrics analysis /li /brliTechnical documentation and process optimization /li /brliCross-functional collaboration and stakeholder management /li /brliCoaching, mentoring, and knowledge sharing /li /brliEffective communication and influencing skills /li /brliStrong business acumen and strategic thinking /li /brliCritical thinking and sound judgment in complex environments /li /brliAbility to drive results with minimal supervision and high accountability. /li /br /ul /br /brh3Compensation /h3 /brpIn line with our commitment to transparency and equal pay, we provide the following information: /p /brul /brliSalary Range: 35.000€ - 45.000€. /li /brliNCBA: Chimica, Concia e settori accorpati, CONFAPI. /li /brliThis position is eligible for corporate premio . /li /br /ul /br /brpThis 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. /p /br /brpSTERIS 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 /p /br /brpSTERIS strives to be an Equal Opportunity Employer. /p #J-18808-Ljbffr