Sr. Quality Manager
2 weeks ago
This role involves implementing and maintaining quality systems aligned with regulatory requirements, ensuring compliance with ISO 9001 and GMP standards. Responsibilities include developing team capabilities, overseeing audits, driving process improvements, and maintaining regulatory compliance across the organization.
Client Details
A global leader in analytical instruments and services, the company specializes in innovative solutions for the biopharmaceutical, clinical, and food & beverage industries. Its diverse portfolio includes cutting-edge technologies for clonal isolation, micro-osmometers for GMP workflows, and tools that enhance efficiency and productivity in clinical labs worldwide.
Description
- Manage QA and QC teams to support organizational functions and ensure product quality.
- Lead Quality Management System (QMS) activities, including CAPA, NCMR, audits, and complaints.
- Coordinate global QMS processes to ensure consistency across multiple sites.
- Support new product development with compliance in requirements, specifications, and test protocols.
- Oversee product and process changes, ensuring risk management and regulatory compliance.
- Act as the QMS expert, staying updated on regulatory changes and industry standards.
- Drive a culture of quality and continuous improvement across the organization.
Profile
- Expert in ISO 13485, ISO 9001, FDA QSR, IVDR, and safety standards.
- 10+ years of quality systems experience in medical devices and in vitro diagnostics (IVD).
- 5+ years of leadership in team management and performance development.
- Proven success in managing ISO/MDSAP audits and regulatory inspections.
- Proficient in electronic QMS platforms and data-driven tools.
- Strong communicator with exceptional organizational skills.
Job Offer
Leadership Role: Directly manage and lead Quality Assurance (QA) and Quality Control (QC) teams, driving quality initiatives across the organization.
Strategic Impact: Lead and enhance the Quality Management System (QMS), including CAPA, audits, and compliance processes, shaping the overall quality strategy.
Global Exposure: Coordinate and align QMS activities with global teams, offering the chance to work across multiple sites and expand international experience.
Innovation and Development: Play a key role in new product development, ensuring regulatory compliance and quality throughout the process.
Continuous Improvement: Foster a strong culture of quality and continuous improvement, making a tangible impact on the organization's success.
Regulatory Expertise: Serve as the QMS expert, staying at the forefront of regulatory changes and industry best practices, advancing career expertise.
Career Growth: Opportunities for professional development in a dynamic, forward-thinking organization, with a focus on leadership and career advancement.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
-
Sr Manager GCP Compliance
4 weeks ago
Boston, MA, United States Gardner Resources Consulting, LLC Full timeSr Manager, GCP ComplianceMUST HAVE: Experience successfully leading event investigations, Root Cause Analysis and CAPAKnowledge of current industry trends and ability to use the latest technologiesHighly organized with strong planning capabilitiesCompliance and quality management experience (across multiple GxP areas) preferredStrong communication, problem...
-
Sr. Quality Officer
2 days ago
Wilson, NC, United States LifePoint Health Full timeJob Description - Sr. Quality Officer (7462-9118) Description Facilitates and coordinates hospital-wide quality management programs to ensure compliance with Joint Commission and other regulatory requirements. Facilitates compliance with core measures. Facilitates Hospital Patient Safety/Quality Council meetings. Prepares and presents quality reports for...
-
Sr. Manager, Quality Assurance
1 month ago
Allen, TX, United States Quest Medical, Inc. Full timeSummary: The Director Quality Assurance leads the Quality Operations and Quality Engineering teams to ensure exceptional product quality and regulatory compliance. This role involves strategic project management to balance multiple projects with competing priorities. Key responsibilities include developing Quality Control Plans, utilizing data to enhance...
-
Sr. Manager, IT Quality Systems
1 day ago
San Francisco, CA, United States Blue Harbors Corporation Full timeFull-Time Sr. Manager, IT Quality Systems Position Summary: The IT Senior Manager, R&D and Quality Systems is responsible for implementing and supporting R&D and quality business systems required for drug development in the cGMP environment. This position is responsible for the business analysis, planning, project management, implementation, computer...
-
Sr. Quality Specialist
2 weeks ago
Gardena, CA, United States Volt Full timeCome create your career with VoltVolt is immediately hiring for Sr Quality Specialist in Long Beach, CA.As a Sr Quality Specialist you will: Lead continuous improvement initiatives to boost product/service quality, operational efficiency, and customer satisfaction Create and enforce quality assurance policies and procedures to guarantee adherence to...
-
Sr. Specialist Quality Assurance
1 month ago
San Diego, CA, United States Proclinical Staffing Full timeSr. Specialist Quality Assurance - Contract - San Diego CAProclinical is seeking a Sr. Specialist Quality Assurance to oversee and manage document control activities, including deviations, change control, training, and maintenance of documents. Primary Responsibilities:This role involves managing and archiving quality-controlled documents and records for...
-
Sr. Manager
2 days ago
Norwood, MA, United States Moderna Therapeutics Full timeModernaTX, Inc. seeks a Sr. Manager for its Norwood, Massachusetts location. Here’s What You’ll Do: Coordinate and manage all aspects of Chemistry, Manufacturing & Controls (CMC) activities related to product launch, including planning, execution, and monitoring of progress. Liaise between all CMC functions, ensuring effective communication and...
-
Sr. Quality Manager
3 weeks ago
Dedham, United States Michael Page Full timeThis role involves implementing and maintaining quality systems aligned with regulatory requirements, ensuring compliance with ISO 9001 and GMP standards. Responsibilities include developing team capabilities, overseeing audits, driving process improvements, and maintaining regulatory compliance across the organization. Client DetailsA global leader in...
-
Sr. Project Manager
3 weeks ago
Woburn, MA, United States Michael Page Full timeThis person will be managing multiple multifamily construction projects on the North Shore of MA. Client Details Family owned GC, based in Woburn MA, is looking to hire a strong Senior Project Manager to join their team! Lead large & complex Multifamily projects $25M+ Large focus on company culture & retaining employees, resulting in long-tenured...
-
Sr Manager, Employee Relations
4 weeks ago
Boston, MA, United States Gardner Resources Consulting, LLC Full timeSr Manager, Employee RelationsMust Have:7 years experience in Employee RelationsSolid ER experience in Pharma industry, supporting functions in Commercial, Research, Manufacturing, Med Affairs, Regulatory and InternationalAbility to work independently, cross functionally, multi-task, project management skills, excellent communication and report writing...
-
Sr. Project Manager
2 weeks ago
Woburn, MA, United States Michael Page Full timeThis person will be managing multiple multifamily construction projects on the North Shore of MA.Client DetailsFamily owned GC, based in Woburn MA, is looking to hire a strong Senior Project Manager to join their team!Lead large & complex Multifamily projects $25M+Large focus on company culture & retaining employees, resulting in long-tenured employees!They...
-
Sr. Project Manager
4 weeks ago
Woburn, MA, United States Michael Page Full timeThis person will be managing multiple multifamily construction projects on the North Shore of MA.Client DetailsFamily owned GC, based in Woburn MA, is looking to hire a strong Senior Project Manager to join their team!Lead large & complex Multifamily projects $25M+Large focus on company culture & retaining employees, resulting in long-tenured employees!They...
-
Sunnyvale, CA, United States Amazon Full timeSr. Quality Engineering Manager, Amazon Devices, Quality & Lean Job ID: 2808756 | Amazon.com Services LLC - A57 Amazon Lab126 is an inventive research and development company that designs and engineers high-profile consumer electronics. Lab126 began in 2004 as a subsidiary of Amazon.com, Inc., originally creating the best-selling Kindle family of products....
-
Sr. Specialist, Quality Engineer
2 weeks ago
Camden, AR, United States L3Harris Technologies Full timeJob Title: Sr. Specialist, Quality Engineer Job ID: 17466 Job Location: Camden, AR, On-Site Job Schedule: 4/10, Employees work 10 hours per day, 4 days a week Job Description: The Aerojet Rocketdyne Segment of L3Harris Technologies is seeking a Sr. Specialist, Quality Engineer to join our growing facility in Camden, Arkansas . Under general supervision,...
-
Sr Manager- Preconstruction
1 day ago
Boston, MA, United States Shawmut Full timeOverview: At Shawmut Design and Construction, we’re proud that the culture we’ve built as a 100% employee-owned company has been recognized with over 83 Best Place to Work awards, including Best Workplace by Fortune Magazine, Fortune Best Workplace for Women, Fortune Best Workplace for Millennials, Great Place to Work’s Best Workplace for Parents, and...
-
Senior Quality Nurse
1 day ago
Albuquerque, NM, United States American Health Quality Association Full timeFor those who want to invent the future of health care, here's your opportunity. We're going beyond basic care to health programs integrated across the entire continuum of care. Join us to start Caring. Connecting. Growing together. The Sr. Clinical Quality Consultant (CQC) RN will drive consistency, efficient processes and share best practices, in a...
-
Sr. Assoc. Quality Engineer
2 weeks ago
Cape Canaveral, FL, United States L3Harris Technologies Full timeJob Title: Sr. Assoc, Quality Engineer Job Code: 17788 Job Location : Orlando, Florida Job Schedule: 9/80 - work 9 out of every 14 days, totaling 80 hours worked and every other Friday off Job Description: Aerojet-Rocketdyne, an L3Harris Technologies Company, i s seeking a highly motivated, experienced Sr. Assoc., Quality Engineer whose primary...
-
Sr. Engineering Manager
4 weeks ago
Dallas, TX, United States TTS Technologies Full timeSr. Engineering ManagerFull time / Direct HireOnsite in Dallas, TexasStart: ASAPSalary: 130-155K + bonusOur manufacturing client is looking for a Sr. Engineering Manager to manage all aspects of the engineering and maintenance functions.Duties:Management of engineers and maintenance managers/supervisors.Check preventative maintenance programs for the...
-
Sr. Event Manager
2 days ago
Boston, MA, United States Nth Degree Full timeWorking at Nth Degree, we don’t merely manage trade shows, exhibits, and events. Our job is to craft experiences that help build stronger brands—and we relish it. Live events are back, and we are busier than ever! Due to massive growth, we are looking to add a Sr. Event Manager who will have a focus on housing to Nth Degree’s corporate events team....
-
Sr Project Manager
2 weeks ago
Canton, MA, United States Michael Page Full timeWe are partnered with a very reputable Civil contractor based in South Shore, MA. Due to a large portfolio of work, this leading Contractor is seeking a Senior Project Manager to join their team. This opportunity comes with huge growth potential as my client looks to continue building the company. Client DetailsA large-scale construction firm that maintains...