Job TitleSenior Manager, Quality Operations
Location(s)Hopkinton
About Us
Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world’s greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our team of 11,000+ colleagues from around the globe are vital to our success and the reason we’re able to push boundaries in pursuit of better human health.
Find your future at Revvity
Our team is seeking a Senior Manager, Quality Operations to join us in our efforts to serve customers around the world. As the Senior Manager, Quality Operations, driving a high standard for product quality output while working across partnering functions will be critical and an exciting opportunity.
Routine Responsibilities:
-
Provide direct, hands-on leadership for quality operations, including shop floor presence and real-time problem solving, while evaluating processes and policies for improvements on speed and output.
-
Oversee team responsible for quality control testing, inspection processes, and release of manufactured products
-
Lead manufacturing quality investigations and implement effective corrective actions
-
Coach and mentor Quality Engineers to build technical expertise and drive accountability.
-
Connect cross-functional teams, set expectations, and remove barriers to expedite customer response/closure.
-
Lead strategic improvement initiatives to advance site-wide quality standards.
-
Drive digital modernization efforts in partnership with the digital technologies
-
Manage team focused on incoming inspection, in-process controls, and final product release processes, establishing improvements based on experience
-
Develop and implement practical quality control methods for production environments
-
Prepare for and host FDA, ISO, and customer audits with focus on manufacturing areas as well as cross functional site quality influences.
-
Drive operational quality metrics, trending, and continuous improvement initiatives
-
Ensure proper validation of manufacturing processes, equipment, and test methods
-
Collaborate closely with Production, Design Engineering, and Supply Chain to resolve quality issues
-
Implement effective nonconformance management and material review processes
-
Ensure manufacturing personnel are properly trained on quality requirements
-
Oversee and maintain Corrective and Preventive Action (CAPA) Program and ensure all quality events are documented, investigated, assessed for impact, root cause and risk, and all associated actions are completed in a timely manner.
-
Ensure all Risk Management activities are executed and maintained according to all regulatory standards.
-
Represent Quality for new and existing product development/manufacturing transfers and quality plan initiatives.
-
Manage Quality Management Review
-
Actively participate in Operations and other business review meetings
-
Ensure the effectiveness of QMS training program
-
Monitors audits of production and Quality Control areas.
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time.
Basic Qualifications:
-
Bachelor of Science degree.
-
10+ years of Quality experience
-
5+ years management experience
Preferred Qualifications:
-
Experience working in a manufacturing and/or production environment
-
Experience implementing and executing within ISO 13485, US FDA 820, and CMDCAS complaint Quality Management Systems
-
Expertise in risk management, root cause investigation, corrective/preventive action, and data analytics practices, tools and principles
-
Experience developing long-term strategic goals
-
Experience establishing operational objectives and work plans
-
Experience establishing and assuring adherence to budgets, schedules, workplans, and performance requirements.
Working Conditions: The primary working condition associated with this position is working independently in the office environment. It is frequently required to work cross-functionally. Travel may be required up to 10%.
Mental and Physical Demands: Requires the ability to lift and carry up to 25 pounds, sit and/or stand for prolonged periods of time and effectively manage conflict and emotional or stressful situations.
Potential Job and Task Hazards: Potential hazards associated with blood products.
#LI-CH1
What do we offer?
We provide competitive and comprehensive benefits to our employees. Below are some highlights of our benefits:
-
Medical, Dental, and Vision Insurance Options
-
Life and Disability Insurance
-
Paid Time-Off
-
Parental Benefits
-
Compassionate Care Leave
-
401k with Company Match
-
Employee Stock Purchase Plan
Learn more about Revvity’s benefits by visiting our Bswift page. Log-In instructions are provided towards the bottom of the Bswift page.
*For benefit-eligible roles only. Part-time and temporary roles may not be eligible for all benefits listed. Please reach out to your recruiter for more information.
Revvity is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any characteristic or status protected by applicable federal, state, and/or local laws. If you are an applicant with a disability that requires reasonable accommodation to complete any part of the application process or are limited in the ability—or unable to use—the online application system and need an alternative method for applying, you may contact [email protected].
Top Skills
What We Do
At Revvity, “impossible” is inspiration, and ""can't be done"" is a call to action. Revvity provides health science solutions, technologies, expertise and services that deliver complete workflows from discovery to development, and diagnosis to cure. Revvity is revolutionizing what’s possible in healthcare, with specialized focus areas in translational multi-omics technologies, biomarker identification, imaging, prediction, screening, detection and diagnosis, informatics and more. With more than $3 billion in revenue and over 11,000 employees, Revvity serves customers across pharmaceutical and biotech, diagnostic labs, academia and governments. It is part of the S&P 500 index and has customers in more than 190 countries. Learn more at www.revvity.com