Join Steris as Manager, Quality Systems in Waltham Massachusetts. At the Steris you will perform tasks as listed below, Apply Steris career in Waltham MA.
Position : Manager, Quality Systems
Job Category: Quality
Work location : Waltham, Massachusetts
Job Segment : Medical, Engineer, CAPA, Quality Manager, Quality, Healthcare, Engineering, Management
At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
The person in this Quality Manager role is responsible for leading quality improvement for an AST (Applied Sterilization Technologies) processing facility. This person will lead the strategy of implementing and maintaining state-of-the-art quality practices and will assume overall responsibility in ensuring that the site maintains operational and quality systems in a state of compliance to domestic and international standards. This person will focus on the documentation and maintenance of the quality system to be compliant with, as appropriate, the following standards such as ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards. In addition, you would lead the local site efforts focused on quality system improvement, supplier quality, process quality, new service/modality/technology development and overall quality system compliance. This person will need to coordinate with corporate quality strategies, will adapt quality and compliance strategies pertaining to this specific needs of this site, and will effectively develop and manage a team of 3-6+ Quality Engineers and Specialists to improve the overall quality of services/products/suppliers managed by this team.
• Lead the organization’s Quality staff to ensure compliance to the overall Quality Management System and drive continuous improvement.
• Lead the organization’s Quality staff to ensure alignment to operations, support Lean efforts and drive quality improvement for services/processes.
• Work closely with site senior management to provide strategic direction and development of the organization’s quality strategies and tactics.
• Provide quality viewpoints and opinions on future service/technology offerings.
• Provide coaching, mentoring and leadership to the Quality staff.
• Serve as the site’s Management Representative and lead the organization’s Management Review process.
• Ensure compliance with appropriate domestic regulatory and international standards and requirements.
• Lead the organization’s continuous improvement process; including data analysis, improvement projects and process capability to improve key metrics as measured by the product/service quality dashboard.
• Lead and implement effective production and process controls.
• Manage the CAPA, complaint and non-conformance handling processes to insure customer responsiveness and process improvements.
• Responsible for successfully leading and managing Regulatory Agency and Notified Body inspections and driving the creation and implementation of sustainable and effective remediation plans. Responsible for overseeing completion of Customer audits.
• Apply regulatory knowledge and judgment to the evaluation of quality concerns and regulatory compliance issues.
• Travel to other AST facilities, domestically and/or globally, to support remediation activities, audits/inspections and/or continuous improvement initiatives.
• Overall responsibilities include commitment to ensure external and internal requirements are met according to documented policies, procedures, standards and regulations.
• The position requires a level of authority to conduct and direct required activities such as quality planning, personnel management and regulatory compliance.
• Perform other duties as assigned.
• 10 or more years of experience in manufacturing or processing environment or another technical/scientific field. A Bachelor’s Degree is required, preferably in a related scientific/technical field
• Manufacturing/Quality Engineering and/or Quality Systems experience with medical device or other highly regulated industries preferred
• 10 years of experience working in an ISO certified environment required with experience in Sterilization manufacturing/processing environments preferred
• Minimum of 2 years in a Quality leadership or management role managing a team of direct reports
• Working knowledge of FDA QSR/ EUGMP regulations strongly preferred.
STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics. We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers in more than 100 countries.
STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.
Nearest Major Market: Waltham
Nearest Secondary Market: Boston
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