Current jobs related to Supplier Quality Engineer - Holly Springs NC United States - FUJIFILM Diosynth Biotechnologies

  • Supplier Quality Engineer

    1 month ago

    Holly Springs, United States FUJIFILM Diosynth Biotechnologies Full time

    Supplier audits in cGMP supporting Biotech/pharma industries are highly preferred.Supplier Quality Senior Engineer provides supplier oversight to ensure that suppliers of services or materials to Fujifilm Diosynth Biotechnologies are of the highest quality while conforming to pre-established requirements including cGMPs. This role primarily focuses on...

  • Sr. Engineer, Supplier Quality

    2 weeks ago

    Holly Springs, United States CV Library Full time

    Overview:Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMOThe work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to...

  • Supplier Quality Engineer 2

    3 weeks ago

    Charlotte, NC, United States Manpower Engineering Full time

    Our client in the manufacturing industry is seeking a Supplier Quality Engineer 2 to join their team. As a Supplier Quality Engineer, you will be part of the Supplier Quality Management (SQM) team supporting Generation Core Engine parts with high technical/quality level. The ideal candidate will have strong analytical thinking, leadership skills, and...

  • Supplier Quality Engineer

    3 weeks ago

    Shelbyville, TN, United States ResourceTek Full time

    Supplier Quality Engineer Is this the next step in your career Find out if you are the right candidate by reading through the complete overview below. ResourceTek is the Human Capital division of Barge Design Solutions, a multi-discipline Engineering and Architecture firm. We specialize in providing technical recruitment and staffing services to industry...

  • Supplier Quality Engineer

    4 weeks ago

    Germantown, MD, United States Echostar Full time

    EchoStar has an exciting opportunity for a Supplier Quality Engineer in our Hughes Network Systems division. This position will be located in our Germantown, MD location. Responsibilities:Working with suppliers of various mechanical components, to ensure compliance to HNS requirements and metrics.Document & communicate issues using measurement, photographic...

  • Supplier Quality Engineer

    4 weeks ago

    Germantown, MD, United States Echostar Full time

    EchoStar has an exciting opportunity for a Supplier Quality Engineer in our Hughes Network Systems division. This position will be located in our Germantown, MD location. Responsibilities:Working with suppliers of various mechanical components, to ensure compliance to HNS requirements and metrics.Document & communicate issues using measurement, photographic...

  • Engineer, Supplier Quality

    4 weeks ago

    Alpharetta, GA, United States Stryten Energy Full time

    OverviewStryten Energy, a growing team of 2,500 willing and fearless listeners, learners, and problem solvers works to meet the increasing demand for reliable energy storage technologies. From submarines to subcompacts, Stryten Energy builds innovative battery solutions that power everything from warehouses and distribution centers to cars, trains and...

  • Lead, Supplier Quality Engineer

    2 weeks ago

    Orange, VA, United States L3Harris Technologies Full time

    Job Title: Lead, Supplier Quality Engineer Job Code: 18480 Job Location: Culpeper, VA Job Schedule: 9/80: Employees work 9 out of every 14 days - totaling 80 hours worked - and have every other Friday off Job Description: The Lead, Supplier Quality Engineer (SQE) is responsible for ensuring that delivered products and/or services conform to contractual and...

  • Supplier Quality Engineer 2

    3 weeks ago

    Charlotte, NC, United States Manpower Engineering Full time

    Our client in the manufacturing industry is seeking a Supplier Quality Engineer 2 to join their team. As a Supplier Quality Engineer, you will be part of the Supplier Quality Management (SQM) team supporting Generation Core Engine parts with high technical/quality level. The ideal candidate will have strong analytical thinking, leadership skills, and...

  • Lead, Supplier Quality Engineer

    3 weeks ago

    Orange, VA, United States L3Harris Technologies Full time

    Job Title: Lead, Supplier Quality EngineerJob Code: 18480Job Location: Culpeper, VAJob Schedule: 9/80: Employees work 9 out of every 14 days – totaling 80 hours worked – and have every other Friday off  Job Description: The Lead, Supplier Quality Engineer (SQE) is responsible for ensuring that delivered products and/or services conform to contractual...

  • Lead, Supplier Quality Engineer

    3 weeks ago

    Orange, VA, United States L3Harris Technologies Full time

    Job Title: Lead, Supplier Quality EngineerJob Code: 18480Job Location: Culpeper, VAJob Schedule: 9/80: Employees work 9 out of every 14 days – totaling 80 hours worked – and have every other Friday off  Job Description: The Lead, Supplier Quality Engineer (SQE) is responsible for ensuring that delivered products and/or services conform to contractual...

  • Supplier Quality Engineer

    3 weeks ago

    Russells Point, OH, United States Honda Development and Manufacturing of America Full time

    What Makes a Honda, is Who makes a Honda Honda has a clear vision for the future, and it's a joyful one. We are looking for individuals with the skills, courage, persistence, and dreams that will help us reach our future-focused goals. At our core is innovation. Honda is constantly innovating and developing solutions to drive our business with record...

  • Supplier Quality Engineer

    3 weeks ago

    Russells Point, OH, United States Honda Development And Manufacturing Of America Full time

    What Makes a Honda, is Who makes a Honda Honda has a clear vision for the future, and it's a joyful one. We are looking for individuals with the skills, courage, persistence, and dreams that will help us reach our future-focused goals. At our core is innovation. Honda is constantly innovating and developing solutions to drive our business with record...

  • Supplier Quality Engineer

    4 weeks ago

    Russells Point, OH, United States Honda Development and Manufacturing of America Full time

    What Makes a Honda, is Who makes a Honda Honda has a clear vision for the future, and it's a joyful one. We are looking for individuals with the skills, courage, persistence, and dreams that will help us reach our future-focused goals. At our core is innovation. Honda is constantly innovating and developing solutions to drive our business with record...

  • Lead Supplier Quality Engineer

    2 weeks ago

    Baltimore, MD, United States Mras USA Full time

    ST Engineering MRAS is a world-leading manufacturer of complex aerostructures including nacelle systems and specialized structural components of the airframe. It supplies and supports these products for engine makers, airplane manufacturers, and aircraft operators. Located on Maryland's Chesapeake Bay near Baltimore, MRAS has a 1.4-million sq. ft. facility...

  • Supplier Quality Engineer

    2 months ago

    Russells Point, OH, United States Honda Development and Manufacturing of America Full time

    What Makes a Honda, is Who makes a Honda Honda has a clear vision for the future, and it's a joyful one. -We are looking for individuals with the skills, courage, persistence, and dreams that will help us reach our future-focused goals. At our core is innovation. Honda is constantly innovating and developing solutions to drive our business with record...

  • Supplier Quality Engineer

    5 months ago

    Russells Point, OH, United States Honda Development and Manufacturing of America Full time

    What Makes a Honda, is Who makes a HondaHonda has a clear vision for the future, and it's a joyful one. We are looking for individuals with the skills, courage, persistence, and dreams that will help us reach our future-focused goals. At our core is innovation. Honda is constantly innovating and developing solutions to drive our business with record...

  • Supplier Quality Engineer

    3 months ago

    Russells Point, OH, United States Honda Development and Manufacturing of America Full time

    What Makes a Honda, is Who makes a HondaHonda has a clear vision for the future, and it’s a joyful one.  We are looking for individuals with the skills, courage, persistence, and dreams that will help us reach our future-focused goals. At our core is innovation. Honda is constantly innovating and developing solutions to drive our business with record...

  • Supplier Quality Engineer

    5 months ago

    Russells Point, OH, United States Honda Development and Manufacturing of America Full time

    What Makes a Honda, is Who makes a HondaHonda has a clear vision for the future, and it’s a joyful one.  We are looking for individuals with the skills, courage, persistence, and dreams that will help us reach our future-focused goals. At our core is innovation. Honda is constantly innovating and developing solutions to drive our business with record...

  • Senior Supplier Quality Engineer

    2 weeks ago

    Danbury, CT, United States Leonardo DRS Full time

    The Leonardo DRS Naval Power Systems business is a trusted provider of innovative naval gas and hybrid power systems, control technology and support solutions for the U.S. Navy and navies around the world. Job Summary This position is responsible for supplier quality, supporting procurement, and supporting supplier development improvements. Performs supplier...

Supplier Quality Engineer

1 month ago

Holly Springs NC United States FUJIFILM Diosynth Biotechnologies Full time

Supplier audits in cGMP supporting Biotech/pharma industries are highly preferred.


Supplier Quality Senior Engineer provides supplier oversight to ensure that suppliers of services or materials to Fujifilm Diosynth Biotechnologies are of the highest quality while conforming to pre-established requirements including cGMPs. This role primarily focuses on supplier quality, working with suppliers to maintain supplier approvals. Initially, this position will be key to the establishing the Supplier Quality System including but not limited to SOP and Specification development, Quality Agreements, Risk Assessments, Supplier Auditing and Supplier Change Notifications. The ability to effectively collaborate, influence, and coordinate amongst suppliers and team members within Supply Chain, Quality Control, and Quality Management is critical to this role.


About the Role

  • Prepares, conducts, and reports results of audits of GMP service providers and suppliers of various GMP materials, and internal processes to meet quality compliance requirements.
  • Creates and maintains a list of approved suppliers/service providers.
  • Establishes and maintain policies, procedures, checklists, self-assessment surveys, and additional forms for the internal and supplier audit programs.
  • Monitors raw material supplier quality and works directly with Supply Chain, QA, and suppliers to improve performance.
  • Oversees and reports on the progress of audit corrective and preventative actions and audit findings for both the internal and supplier audit programs during Quality Management Meetings.
  • Supports Quality management contact with the FDA, EMA and other regulatory authorities worldwide as well as partners regarding quality issues including field alerts, recalls or regulatory actions.
  • Supports GMP inspections and audits from both regulatory authorities and partners and supports drafting of follow-up responses for all aspects of the business.
  • Supports other GXP functions, as required.
  • Supports and participates in the supplier change notification and supplier complaints.
  • Performs other duties, as assigned
  • Travel up to 50%, domestic and international


Qualifications

• Bachelor’s Degree in Life Sciences or Engineering with 9+ years of applicable cGMP experience OR

• Masters in Life Sciences or Engineering and 7+ years of applicable cGMP experience OR

• PhD in Life Sciences or Engineering and 5+ years of applicable cGMP experience

•5+ years’ experience of auditing experience

• Prior Experience and Knowledge of pharmaceutical industry and regulations



Preferred Skills

  • Previous experience of Smartsheet, Track wise, Master Control, Veeva and/or Kneat validation software
  • Occasional opportunity for International and/or Domestic travel may be available
  • Experience conducting internal audits
  • Certified ISO 9001 Auditor Training
  • ASQ - Certified Quality Auditor