Senior Manager, Quality Laboratory

2 weeks ago

Irvine, United States Edwards Lifesciences Full time

Provide leadership and management of the site laboratories (e.g., Microbiology, Chemistry) including sterility assurance, production support and environmental monitoring in support of production operation.

How You Will Make Impact:

  • Manage and/or oversee the work of assigned team within a site laboratory (e.g., Microbiology, Chemistry) including responsibilities on on-going projects within manufacturing in collaboration with key stakeholders, oversee qualification of lab equipment, department budget, the development and validation of laboratory test methods in support of production and/or new product/process development. Overall leadership in ensuring Lab processes/personnel complies with pertinent Laboratory Environmental and Safety regulations.
  • Manage project activities with the accountability for successful completion of all deliverables to the business and develop project plans, schedule, scope and objectives. Identify risks, develop mitigation strategies, define alternative solutions, resolve issues, and follow-up on action items in collaboration with cross functional groups
  • Plan and lead the execution of laboratory activities to support supply chain and processes in accordance with applicable regulations, standards and guidelines
  • Develop a robust talent development plan in alignment with functional growth strategies of the department including meeting the needs of the organization and customers and to better understand core competencies
  • Lead in the development, monitoring and publishing of appropriate metrics for the organization
    Identify risk, develop and lead in the implementation of strategies which may include negotiations with internal and external stakeholders. Develop strategies and address trends and issues within own area including risk management
  • May actively participate in the EW Global Laboratory council to help drive consistency and improvement and lead initiatives across laboratory network
  • Other incidental duties: Participate in cross-functional workstreams leading to continuous improvement (e.g., Lean Six Sigma). Facilitate team to ensure laboratory specific investigations are performed in compliance with quality and regulatory requirements.
What You'll Need (Required):
  • Bachelor's Degree in in related scientific field (e.g., chemistry, biology or microbiology) related experience within applicable regulated laboratory Required and
  • Experience in Quality management in the medical device, pharmaceutical industry, or the equivalent Required and
  • Demonstrated track record in effective laboratory management, including compliance, technical excellence, and organizational development Required
What Else We Look For (Preferred):
  • Proven successful project management leadership skills
  • Proven expertise in both Microsoft Office Suite and related systems
  • Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
  • Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
  • Expert understanding of quality laboratory and technical procedures while addressing issues with impact beyond own team based on knowledge of related disciplines
  • Expert understanding of related aspects of quality laboratory processes and/or systems
  • Expert knowledge of FDA Quality System Regulations, Good Laboratory Practices (GLP) and ISO/EN standards
  • Knowledge of financial acumen as it relates to the business as well as quality laboratories
  • Demonstrated ability to manage teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
  • Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality laboratories to the business
  • Serve as core partner to senior leaders in Business Units, Functional Groups, and Regions
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
  • Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
  • Frequently interacts with subordinate production supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company; often leads a cooperative effort among members of a project team
  • Participate and present at meetings with internal and external representatives
  • Resolve operational and scheduling issues
  • Dedicated to quality client service and pro-active and responsive to client needs.
  • Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
  • Develop relationships and leverage them to influence change
  • Support and solicit input from team members at all levels within the organization
  • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control


Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $133,000 to $187,000(highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

  • Senior Manager Quality Control

    3 weeks ago

    Irvine, United States The Custom Group of Companies Full time

    Senior Manager Quality Control Responsibilities: Work with Quality Control teams ensuring that all laboratory operations support the manufacturing operations and Markwins business objectives, and that the laboratory operations comply with all the laws, regulations, and guidance applicable to pharmaceutical drug manufacturing. Interacts with production...

  • Laboratory Quality Technician II

    7 days ago

    Irvine, United States Akkodis Full time

    A Laboratory Quality Technician position in Irvine, CA is available courtesy of Akkodis.Type: ContractDuration: 3+ months (possible extension and/or conversion)Location: Irvine, CARange: $27.11Quality Laboratory TechnicianRESPONSIBILITIES:Responsible for inspection and testing of assigned medical device components in accordance to QSR, company policy and...

  • Laboratory Quality Technician II

    6 days ago

    Irvine, United States Akkodis Full time

    A Laboratory Quality Technician position in Irvine, CA is available courtesy of Akkodis.Type: ContractDuration: 3+ months (possible extension and/or conversion)Location: Irvine, CARange: $27.11Quality Laboratory TechnicianRESPONSIBILITIES:Responsible for inspection and testing of assigned medical device components in accordance to QSR, company policy and...

  • Laboratory Administrative Manager

    3 weeks ago

    Irvine, United States IntelliPro Group Inc. Full time

    Job DescriptionJob DescriptionJob Title: Laboratory Administrative ManagerPosition Type: Full TimeLocation: Irvine, CASalary Range: $60k-80k/yrJob Responsibilities:Responsible for docking with US California government departments and US federal agricultural departments, applying for the company's application permits in US laboratories EPA, EHS and...

  • Laboratory Analyst

    2 weeks ago

    Irvine, United States PML Full time

    Job DescriptionJob DescriptionLaboratory Analytical Chemist Job Responsibilities:The Analytical Chemist will be involved in the application of validated methods in modernanalytical techniques, including UHPLC, Triple Quadrupole LC-, GC-MS/MS, ICP-MS, GC-MSD,and qPCR to provide consistently accurate and timely results. The successful candidate will...

  • Laboratory Coordinator

    1 week ago

    Irvine, United States Planet Pharma Full time

    6 month extendable contractOnsite in Irvine, CASummary:Support laboratory operations.Responsibilities:Perform media preparation, accurately measuring and dispensing, in compliance with established work instructions and adherence with SOPs, including recording traceable informationPerform basic laboratory support functions such as laboratory inventory...

  • Senior Quality Engineer

    1 week ago

    Irvine, United States Motion Recruitment Full time

    Title: Senior Engineer (Quality) Location: Irvine, CA Duration: Contract About the Client: Join a distinguished member of the Fortune 100 community, specializing in cutting-edge medical devices tailored for critical care, structural heart interventions, and surgical monitoring. With a rich heritage built upon values of integrity, collaboration, and...

  • Senior Quality Engineer

    2 weeks ago

    Irvine, United States Motion Recruitment Full time

    Title: Senior Engineer (Quality)Location: Irvine, CADuration: Contract About the Client:Join a distinguished member of the Fortune 100 community, specializing in cutting-edge medical devices tailored for critical care, structural heart interventions, and surgical monitoring. With a rich heritage built upon values of integrity, collaboration, and relentless...

  • Senior Quality Engineer

    2 weeks ago

    Irvine, United States Motion Recruitment Full time

    Title: Senior Engineer (Quality)Location: Irvine, CADuration: Contract About the Client:Join a distinguished member of the Fortune 100 community, specializing in cutting-edge medical devices tailored for critical care, structural heart interventions, and surgical monitoring. With a rich heritage built upon values of integrity, collaboration, and relentless...

  • Director, Quality Control Lab

    1 week ago

    Irvine, United States CPS Full time

    Posted: 02/13/2024 Industry: Laboratory - Food & Beverage Job Number: 44.24KK Experience: Job Description Director, Quality Control Lab The detailed duties and responsibilities of the Director, Quality Control Lab will include: Provides leadership, guidance and direction to QC lab to support the departments and company’s strategic initiatives and...

  • Senior Quality Assurance Reviewer

    2 weeks ago

    Irvine, United States Kelly Services, Inc. Full time

    #x. A 0; Review all QC HPLC, GC, CE , AAS. TOC, UV, KF, FTIR and NIR assay and impurity results for Raw Materials, Finished Goods, Stability Products. Monitor all Controlled Products, Raw materials, Standards receiving, usage and inventory. Deacom Ti Quality Assurance, Assurance, QA Manager, Quality, Senior, Technology, Staffing

  • Senior Supplier Quality Engineer

    3 days ago

    Irvine, United States Diverse Lynx Full time

    Title: Senior Supplier Quality Engineer Location: : Irvine, CA - Onsite Full time/ Permanent 1. Working knowledge of regulatory compliance requirements (i.e. Quality System Regulations (QSRs), Medical Device Directive (MDD), ISO 9001, ISO 13485, ISO 14971. 1. Provides overall quality assurance leadership in the management of Direct, Indirect Suppliers and/or...

  • Biotech Laboratory Coordinator

    1 week ago

    Irvine, United States TechData Service Company LLC Full time

    Job DescriptionJob DescriptionSummary:Support laboratory operations.Responsibilities:• Perform media preparation, accurately measuring and dispensing, in compliance with established work instructions and adherence with SOPs, including recording traceable information• Perform basic laboratory support functions such as laboratory inventory management,...

  • Senior Supplier Quality Engineer

    3 days ago

    Irvine, United States Discover International Full time

    I am working with a top company in the Medical Device space and they are building out their Supplier Quality team! They are looking for someone who is an experienced Senior Supplier Quality Engineer, skilled with class II and III devices. This role will focus both on NPD and Sustaining and this person will be responsible for leading their Supplier Quality...

  • Senior Supplier Quality Engineer

    5 days ago

    Irvine, United States Discover International Full time

    I am working with a top company in the Medical Device space and they are building out their Supplier Quality team! They are looking for someone who is an experienced Senior Supplier Quality Engineer, skilled with class II and III devices. This role will focus both on NPD and Sustaining and this person will be responsible for leading their Supplier Quality...

  • Senior Quality Engineer

    24 hours ago

    Irvine, United States ShiftCode Analytics Full time

    Title: Senior Quality Engineer (Design) Location: Irvine, CA On-site Duration: 6 months+ Visa: Any Visas(except h1b and CPT) Interview: Phone/Zoom Key Role Responsibilities: •Focus on activities supporting design control, design verification/validation, FMEA/risk management, specification development, statistical reliability, critical to quality/process...

  • Senior Quality Assurance Specialist

    1 week ago

    Irvine, United States Laird Connectivity Full time

    The Senior Quality Assurance Specialist is responsible for, but not limited to, development, maintenance, coordination and implementation of the Quality Business System in assigned facility. The incumbent will apply knowledge of quality systems and interact with/and provide guidance to functional managers, engineers, and operators in order to meet quality...

  • Senior Quality Assurance Specialist

    12 hours ago

    Irvine, United States Laird Connectivity Full time

    The Senior Quality Assurance Specialist is responsible for, but not limited to, development, maintenance, coordination and implementation of the Quality Business System in assigned facility. The incumbent will apply knowledge of quality systems and interact with/and provide guidance to functional managers, engineers, and operators in order to meet quality...

  • Biomedical Laboratory Technician

    3 weeks ago

    Irvine, United States Akkodis Full time

    A Scientist I/Biomedical Laboratory Technician contract-to-hire position is available in Irvine, CA courtesy of Akkodis.Hour Rate: $27.11/hour (DOE)Location: Irvine, CAType: Contract-to-HireDuties:• Will perform routine and complex testing in compliance with laboratory test methods and procedures to support the stability program, complaint testing, methods...

  • Biomedical Laboratory Technician

    3 weeks ago

    Irvine, United States Akkodis Full time

    A Scientist I/Biomedical Laboratory Technician contract-to-hire position is available in Irvine, CA courtesy of Akkodis.Hour Rate: $27.11/hour (DOE)Location: Irvine, CAType: Contract-to-HireDuties:• Will perform routine and complex testing in compliance with laboratory test methods and procedures to support the stability program, complaint testing, methods...