DiaSorin
Senior Quality Engineer
We are seeking an experienced Senior Quality Engineer to lead and elevate our quality assurance practices. This role is responsible for ensuring our products meet the highest standards of quality, reliability, and performance through advanced test design, process optimization, and cross-functional collaboration. This includes direct responsibility for the quality system development and implementation, validations, process development, design change, corrective and preventive action, change control, and quality audits. The ideal candidate is analytical, detail-oriented, and passionate about continuous improvement and delivering excellent user experiences. Duties and Responsibilities Lead and execute product and process validation activities, including IQ/OQ/PQ protocols, to ensure compliance with internal procedures and regulatory requirements. Conduct thorough risk assessments using tools such as FMEA, risk matrices, and root cause analysis; develop mitigation strategies and ensure ongoing risk control. Analyze and trend non-conformances, deviations, and CAPAs to identify systemic issues; lead investigations and implement effective corrective and preventive actions. Conduct or serve as a lead/coordinator of investigations for corrective and preventive action (CAPA) Support sustaining engineering projects, including product/process changes, equipment upgrades, and capacity expansions, ensuring alignment with quality and compliance standards. Provide mentorship and technical guidance to QA personnel, supporting professional development and fostering a culture of quality. Collaborate cross-functionally with Engineering, Manufacturing, Regulatory Affairs, and Supply Chain to drive quality initiatives and resolve quality-related issues. Define and monitor key quality performance indicators (KPIs); prepare and present reports to management with actionable insights. Review and approve change controls, validations, and quality documentation as a subject matter expert. Continuously improve quality systems, tools, and processes to enhance product quality and operational efficiency. Ensure adherence to applicable standards and regulations (e.g., ISO 13485, FDA 21 CFR Part 820, MDSAP), and lead audit readiness activities. Support Quality system training and participates in the development of training programs regarding all aspects of producing quality products. Own the MRB and Non-conformance processes. Leader in Quality system continuous improvement activities. Mentors personnel to continuously enhance the company's quality culture. Support and participate in other QA related activities as required. Other duties as assigned. Education, Experience and Qualifications Bachelor's degree required with a life science or engineering discipline preference. 8+ Years Experience in Quality Assurance role. 3+ Years Experience with risk management, corrective & preventative action and change control. 3+ Years Knowledge of cGMP regulations (21 CFR 820, ISO 13485). 3+ Years Working knowledge of statistics, trending and root cause analysis. 2+ Years Experience in an Operations support role. Certification in a quality discipline preferred, such as CQE, CQA, CQM. Excellent interpersonal, verbal and written communication skills. Strong skills and knowledge of corporate software tools -- Microsoft Office Suite including Word, Excel, Access and Power Point. High degree of problem solving, attention to detail, and analytical skills. Strong organizational and time-management skills. Lean Sig Sigma Certification. What We Offer Salary Range The hourly range for this position is $20.02 - $32.03. The salary range for this role represents the numerous factors considered in the hiring decisions including, but not limited to, educations, skills, work experience, certifications, etc. Beyond base wages, Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance. Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at hrtalent@diasorin.com or 1-800-328-1482 to request an accommodation. The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations. Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations. This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.
We are seeking an experienced Senior Quality Engineer to lead and elevate our quality assurance practices. This role is responsible for ensuring our products meet the highest standards of quality, reliability, and performance through advanced test design, process optimization, and cross-functional collaboration. This includes direct responsibility for the quality system development and implementation, validations, process development, design change, corrective and preventive action, change control, and quality audits. The ideal candidate is analytical, detail-oriented, and passionate about continuous improvement and delivering excellent user experiences. Duties and Responsibilities Lead and execute product and process validation activities, including IQ/OQ/PQ protocols, to ensure compliance with internal procedures and regulatory requirements. Conduct thorough risk assessments using tools such as FMEA, risk matrices, and root cause analysis; develop mitigation strategies and ensure ongoing risk control. Analyze and trend non-conformances, deviations, and CAPAs to identify systemic issues; lead investigations and implement effective corrective and preventive actions. Conduct or serve as a lead/coordinator of investigations for corrective and preventive action (CAPA) Support sustaining engineering projects, including product/process changes, equipment upgrades, and capacity expansions, ensuring alignment with quality and compliance standards. Provide mentorship and technical guidance to QA personnel, supporting professional development and fostering a culture of quality. Collaborate cross-functionally with Engineering, Manufacturing, Regulatory Affairs, and Supply Chain to drive quality initiatives and resolve quality-related issues. Define and monitor key quality performance indicators (KPIs); prepare and present reports to management with actionable insights. Review and approve change controls, validations, and quality documentation as a subject matter expert. Continuously improve quality systems, tools, and processes to enhance product quality and operational efficiency. Ensure adherence to applicable standards and regulations (e.g., ISO 13485, FDA 21 CFR Part 820, MDSAP), and lead audit readiness activities. Support Quality system training and participates in the development of training programs regarding all aspects of producing quality products. Own the MRB and Non-conformance processes. Leader in Quality system continuous improvement activities. Mentors personnel to continuously enhance the company's quality culture. Support and participate in other QA related activities as required. Other duties as assigned. Education, Experience and Qualifications Bachelor's degree required with a life science or engineering discipline preference. 8+ Years Experience in Quality Assurance role. 3+ Years Experience with risk management, corrective & preventative action and change control. 3+ Years Knowledge of cGMP regulations (21 CFR 820, ISO 13485). 3+ Years Working knowledge of statistics, trending and root cause analysis. 2+ Years Experience in an Operations support role. Certification in a quality discipline preferred, such as CQE, CQA, CQM. Excellent interpersonal, verbal and written communication skills. Strong skills and knowledge of corporate software tools -- Microsoft Office Suite including Word, Excel, Access and Power Point. High degree of problem solving, attention to detail, and analytical skills. Strong organizational and time-management skills. Lean Sig Sigma Certification. What We Offer Salary Range The hourly range for this position is $20.02 - $32.03. The salary range for this role represents the numerous factors considered in the hiring decisions including, but not limited to, educations, skills, work experience, certifications, etc. Beyond base wages, Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance. Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at hrtalent@diasorin.com or 1-800-328-1482 to request an accommodation. The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations. Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations. This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.