Quality Systems Specialist FEATURED

4 weeks ago

Everett, United States Gilder Search Group Full time

Quality Systems Specialist

(On-site to start. Hybrid after you're established in the role) Summary: As the Quality Systems Specialist, you will be actively involved in maintaining and improving all aspects of the Quality System including but not limited to complaints, CAPAs, nonconformances and training. In addition to the primary quality duties, you will leverage your Quality expertise and training to assist other functions in order to meet company goals and objectives.

Direct Supervisor:

Director, Quality and Regulatory Affairs Essential Duties & Responsibilities: Day-to-day

management and support for all QMS activities: CAPA/SCAR Complaints Nonconformances Document Control Audit management Document

Control

Management

(eQMS) Document Processing Document Control training (Intellect) New employee training QMS system update validation management (Intellect) Provide

Guidance

for

project

-based

V

&V

activities

. Required

Skills & Qualifications: Working knowledge/application of QM systems for Medical Device – Biotech - IVD Basic understanding of GMP/FDA (21CFR820) & ISO Regulations (13485) Multitasking/ Problem solving/ Time management/ Collaboration / Communication skills and attention to detail. Strong computer skills – MS Office Familiar with ERP/CRM such as NetSuite/Salesforce Required / Desired Education &

Experience: Working knowledge/application of QM systems for Medical Devices Basic understanding of GMP/FDA (21CFR820) & ISO Regulations (13485) Multitasking/ Problem solving/ Time management/ Collaboration / Communication skills and Attention to detail Strong computer skills – MS Office Familiar with ERP/CRM such as Netsuite/Salesforce Minimum BS degree in a technical discipline such as Engineering/the Sciences/Math/Physics 5+ years’ experience in Quality Internal auditor Training Collaborative Duties & Responsibilities: Applications Training Data analysis (trending & tracking) “SIDS” Batch review Work well in project Team Environment About the Company: Located in metro Boston north, my client is a global organization that has been designing and manufacturing systems for automated microscopic imaging for over 30 years. Today, users in more than 100 countries rely on their laboratory solutions. Their widespread and innovative product portfolio includes image analysis, automated microscopy, and hardware and software technology. As impressive as their technology is their human approach (Servant Leadership) to global business strategies which promotes and fosters a community of employees, partners, users, and customers to achieve a climate of collaboration and friendship. They offer a competitive base salary and bonus package along with an exceptional employee benefit plan that includes 100% paid Medical Insurance for you and your family (less co-pays).

#J-18808-Ljbffr

  • Senior Quality Systems Specialist

    2 weeks ago

    Everett, United States The Boeing Company Full time

    Leads Quality reviews of proposals, contracts, regulatory, program and customer requirements ensuring early quality involvement in program development. Develops Quality budget and cost estimates. Leads multi-function, multi-site groups to develop com Quality, Specialist, Systems, Senior, Technology

  • Quality Assurance Specialist

    7 days ago

    Everett, United States Lampire Biological Laboratories Full time

    **Job Title**: Quality Assurance Specialist **Company Overview**: Lampire Biological Laboratories is a biotech life science company specializing in the production of antibodies, proteins, and other biological products. We offer innovative solutions to meet the research and development needs of our clients in the pharmaceutical and diagnostic industries. We...

  • Quality Assurance Specialist

    4 days ago

    Everett, United States Lampire Biological Laboratories Full time

    Job DescriptionJob DescriptionJob Title: Quality Assurance SpecialistCompany Overview: Lampire Biological Laboratories is a biotech life science company specializing in the production of antibodies, proteins, and other biological products. We offer innovative solutions to meet the research and development needs of our clients in the pharmaceutical and...

  • Quality Assurance Specialist

    10 hours ago

    Everett, United States Lampire Biological Laboratories Full time

    Job DescriptionJob DescriptionJob Title: Quality Assurance SpecialistCompany Overview: Lampire Biological Laboratories is a biotech life science company specializing in the production of antibodies, proteins, and other biological products. We offer innovative solutions to meet the research and development needs of our clients in the pharmaceutical and...

  • 25U Signal Support Systems Specialist

    1 week ago

    Everett, United States Army National Guard Full time

    Job Description Communication is the pulse of Army National Guard units, and it's up to the Signal Support Systems Specialist to ensure the information keeps flowing so the military doesn't miss a beat. Signal Support Systems Specialists are responsible for integrating signal systems and networks; performing signal support functions and unit-level...

  • Windows/VMware Tech Specialist

    1 week ago

    Everett, United States Diverse Lynx Full time

    Job Title: Windows/VMware Tech Specialist Location: Everett, WA (Hybrid) Duration: Long term Job description Must have: • Experience with Active Directory and Group Policy. • Analyzes, logs, tracks and resolves software/hardware matters of significance pertaining to networking connectivity issues, printer, servers, and applications to meet business...

  • CLM System Analyst

    7 days ago

    Everett, United States Technified Solution Full time

    Role-CLM System Analyst Location -Everett, WA Key Responsibilities: Requirements Gathering: Collaborate with business stakeholders to gather and understand requirements for contract management processes. Translate business requirements into actionable configurations within the Icertis CLM system. Icertis CLM Configuration: Utilize your Icertis CLM...

  • Quality Inspector

    1 week ago

    Everett, United States Wipro Givon USA Full time

    Job DescriptionJob DescriptionBenefits:401(k)401(k) matchingCompany partiesDental insuranceHealth insurancePaid time offTraining & developmentVision insurance Wipro Givon USA has an exciting new opportunity for a Quality Specialist to join our team. This position leads the project management of long-term Quality projects and improvements, assists in the...

  • Quality Inspector

    18 hours ago

    Everett, United States Wipro Givon USA Full time

    Job DescriptionJob DescriptionBenefits:401(k)401(k) matchingCompany partiesDental insuranceHealth insurancePaid time offTraining & developmentVision insurance Wipro Givon USA has an exciting new opportunity for a Quality Specialist to join our team. This position leads the project management of long-term Quality projects and improvements, assists in the...

  • Quality Assurance Specialist

    3 weeks ago

    Everett, Washington, United States Defense Contract Management Agency Full time

    Designs/implements/maintains a risk-based surveillance program and assessment plan associated with the quality assurance provisions of contracts. Identifies opportunities for process improvements by analyzing data. As a member of a multi-functional or technical team, implements the overall Quality Program for diverse products and services to support the U.S....

  • Customer Experience Specialist

    13 hours ago

    Everett, United States BRIOTECH Inc Full time

    As the Customer Experience Specialist, you will be responsible for overseeing all customer interactions, and ensuring a seamless and positive experience. You will work closely with our customer experience and marketing teams to handle customer inquiries, resolve issues, and provide exceptional support to enhance customer satisfaction and loyalty. ...

  • CLM System Analyst

    1 week ago

    Everett, United States Technified Solution Full time

    Job Description Job Description Role-CLM System Analyst Location - Everett, WA Key Responsibilities: Requirements Gathering: Collaborate with business stakeholders to gather and understand requirements for contract management processes. Translate business requirements into actionable configurations within the Icertis CLM system. Icertis CLM...

  • CLM System Analyst

    2 weeks ago

    Everett, United States Technified Solution Full time

    Job DescriptionJob DescriptionRole-CLM System AnalystLocation - Everett, WAKey Responsibilities:Requirements Gathering: Collaborate with business stakeholders to gather and understand requirements for contract management processes. Translate business requirements into actionable configurations within the Icertis CLM system.Icertis CLM Configuration: Utilize...

  • CLM System Analyst

    9 hours ago

    Everett, United States Technified Solution Full time

    Job DescriptionJob DescriptionRole-CLM System AnalystLocation - Everett, WAKey Responsibilities:Requirements Gathering: Collaborate with business stakeholders to gather and understand requirements for contract management processes. Translate business requirements into actionable configurations within the Icertis CLM system.Icertis CLM Configuration: Utilize...

  • Development Specialist

    3 weeks ago

    Everett, United States Insight Global Full time

    Title: Employee Development SpecialistDuration: 3-month Contract w/ extensions likelyLocation: Everett, Onsite Monday-FridayShift: 6am-2:30pm Must Haves:• 3-5 years of experience in Aerospace (Structures, QA, Electrical, Mechanical etc)• Experience in instructing/training (speaking in front of 25 or more)• Proficient in MS Office (Word, Excel,...

  • Development Specialist

    3 weeks ago

    Everett, United States Insight Global Full time

    Title: Employee Development SpecialistDuration: 3-month Contract w/ extensions likelyLocation: Everett, Onsite Monday-FridayShift: 6am-2:30pm Must Haves:• 3-5 years of experience in Aerospace (Structures, QA, Electrical, Mechanical etc)• Experience in instructing/training (speaking in front of 25 or more)• Proficient in MS Office (Word, Excel,...

  • Development Specialist

    2 weeks ago

    Everett, United States Insight Global Full time

    Title: Employee Development SpecialistDuration: 3-month Contract w/ extensions likelyLocation: Everett, Onsite Monday-FridayShift: 6am-2:30pm Must Haves:• 3-5 years of experience in Aerospace (Structures, QA, Electrical, Mechanical etc)• Experience in instructing/training (speaking in front of 25 or more)• Proficient in MS Office (Word, Excel,...

  • Development Specialist

    3 weeks ago

    Everett, United States Insight Global Full time

    Title: Employee Development Specialist Duration: 3-month Contract w/ extensions likely Location: Everett, Onsite Monday-Friday Shift: 6am-2:30pm Must Haves: 3-5 years of experience in Aerospace (Structures, QA, Electrical, Mechanical etc) Experience in instructing/training (speaking in front of 25 or more) Proficient in MS Office (Word, Excel,...

  • Non-gaming Accounting Specialist

    1 week ago

    Everett, United States Encore Boston Harbor Full time

    **Company Description** Encore Boston Harbor features 210,000 square-feet of gaming space including more than 3,000 slot machines and 240 table games. Situated on the Mystic River in Everett, Massachusetts, and connected to Boston Harbor, Encore Boston Harbor boasts 671 spacious hotel rooms, a spa, salon and fitness center, specialty retail shops, 15 dining...

  • Systems Engineer 3

    3 weeks ago

    Everett, United States PDS Defense, Inc. Full time

    PDS Defense, Inc is seeking a Systems Engineer 3 in Everett, WA. The selected candidate will help design, certify & support commercial airplanes by applying state-of-art reliability and maintainability engineering design, modeling, and analysis principles R&M Engineering is a key functional discipline that supports airplane development for optimal...