Sr. Quality Engineer

2 months ago

Fremont, United States Cytek Biosciences, Inc. Full time
Job DescriptionJob Description

SUMMARY:

The Senior Quality Engineer will be representing Quality in product development and product improvement initiative projects. This person will plan and lead Quality Engineering activities and support Engineering, Operations, Supply Chain, Customer Facing and other functions on applicable product quality, design control, customer complaint investigations, and risk management processes and use his/her problem-solving and analytical skills.


ESSENTIAL DUTIES AND RESPONSIBILITIES:

To perform this job successfully, an individual must be able to perform essential duties and responsibilities satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


  • Ensure design control activities are satisfied.
  • Lead product related risk management activities.
  • Lead investigation and analysis of failed system modules, create analysis report and provide recommendations and creative solutions for continuous quality improvement.
  • Lead investigation of customer complaints and conduct problem-solving sessions for non-conforming products.
  • Support product and process validation.
  • Generate or apply statistical methods with appropriate risk-based justification.
  • Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and verified.
  • Define critical to quality characteristics and inspection plans for components, subassemblies, and finished devices.
  • Identify and propose remediation for existing and potential quality issues.
  • Ensure that product changes to existing products are conducted in compliance with Regulatory and Quality standards and have approval authority for new/modified for design and process specifications.
  • Maintain expertise in both current and emerging requirements and quality trends as they relate to life science products and medical devices worldwide.
  • May provide guidance and work direction to lower-level Quality Engineers.
  • As a Quality Engineering advisor, provide Quality Engineering guidance and support to internal organizations, regulatory bodies, and customers (e.g., audits, questionnaires).
  • Other duties as assigned.


REQUIREMENTS & QUALIFICATIONS:

The requirements listed below are representative of the knowledge, skill, and/or ability required.

  • Minimum of a BS in Engineering or Scientific discipline; MS preferred.
  • Experience in Biotech instrument development and commercialization activities.
  • Experience with product risk analysis and management throughout product lifecycle.
  • Familiar with process validation principles, including sub-tasks of equipment IQ, OQ, PQ
  • Working knowledge of 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, and ISO 14971 Risk Management Standard, Root Cause Analysis.
  • Familiarity with Kaizen and Six Sigma methodology preferred.
  • CQE preferred.
  • 4+ years’ experience working in the Medical Device and/or Life Science Research product industries.
  • Experience interacting with regulatory agencies and notified bodies and front room audit experience is a plus.
  • Knowledge and experience with corrective action and preventive action system, release test statistical sampling methods, quality risk management, FMEA, and DOE.
  • Knowledgeable in manufacturing techniques and processes.
  • Problem solving, analytical, creativity, and critical thinking skills.
  • Ability to effectively influence others without direct authority and partner with internal and external customers.


PHYSICAL DEMANDS AND WORK ENVIRONMENT:

The physical demands described here are representative of those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.


  • The work environment is a combination of work at the desk and in the production environment to investigate product complaints and work with the manufacturing technicians.


Cytek is an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, gender identity, sexual orientation, national origin, genetic information, disability status, veteran status, or any other characteristic protected by law.


  • Sr. Environmental Engineer, Air Quality

    1 week ago

    Fremont, United States Tesla Full time

    What to ExpectTesla is seeking a dynamic environmental professional to join the Environmental, Health and Safety Team (EHS). The role will support various environmental compliance programs at Tesla’s Fremont Factory in Fremont, CA. Reporting to the Environmental Affairs Manager, the Sr. Environmental Engineer will be responsible for performing complex...

  • Sr. Technician, Assembly

    4 weeks ago

    Fremont, United States Amprius Full time

    Job DescriptionJob DescriptionJob Title: Sr. Technician, Assembly & Quality Reports to: Manufacturing Engineer ManagerJob Type: Non-Exempt, Full-timeLocations: Fremont, CA (On-site)Company DescriptionAmprius develops, designs, and manufactures very high-performance lithium-ion cells for advanced applications. Amprius invented and perfected a 100% silicon...

  • Sr. Technician, Assembly

    3 months ago

    Fremont, United States Amprius Full time

    Job DescriptionJob DescriptionJob Title: Sr. Technician, Assembly & Quality Reports to: Manufacturing Engineer ManagerJob Type: Non-Exempt, Full-timeLocations: Fremont, CA (On-site)Company DescriptionAmprius develops, designs, and manufactures very high-performance lithium-ion cells for advanced applications. Amprius invented and perfected a 100% silicon...

  • Sr. Industrial Engineer

    2 weeks ago

    Fremont, United States Amax Engineering Corp. Full time

    Sr. Industrial Engineer Company: Amax Engineering Corp. Location: Fremont, CA Position Type: Full Time Experience: Unspecified Education: Unspecified Wage $111,072. to $120,000. per year. Send resume to: Amax Engineering Corp.1565 Reliance Way, Fremont, CA 94539

  • Sr. Test Engineer

    2 months ago

    Fremont, United States Tessolve Full time

    Role: Sr. Test Engineer Location: Fremont, CA Type: Contract Duration: 12 months (w/ possibility of extension) Job Description: Senior Test Engineer responsible for developing test program and design of hardware on ATE (Automated Testing Equipment) for product bring up, characterization and eventual mass production testing of very high performance SOC...

  • Sr. Test Engineer

    1 month ago

    Fremont, California, United States Tessolve Full time

    Role: Sr. Test Engineer Location: Fremont, CA Type: Contract Duration: 12 months (w/ possibility of extension) Job Description: Senior Test Engineer responsible for developing test program and design of hardware on ATE (Automated Testing Equipment) for product bring up, characterization and eventual mass production testing of very high performance SOC...

  • Sr. BIOS Engineer

    3 months ago

    Fremont, United States Aivres Full time

    About AivresAivres is a leading global data center and cloud computing solutions provider committed to delivering innovative technologies that propel the world’s leading industries to new frontiers. We deliver and deploy robust, performance-optimized, purpose-built platforms to major data centers around the globe.We are seeking a highly skilled and...

  • Sr. BIOS Engineer

    3 months ago

    Fremont, United States Aivres Full time

    About AivresAivres is a leading global data center and cloud computing solutions provider committed to delivering innovative technologies that propel the world’s leading industries to new frontiers. We deliver and deploy robust, performance-optimized, purpose-built platforms to major data centers around the globe.We are seeking a highly skilled and...

  • Sr. Packaging Engineer, Service

    1 week ago

    Fremont, United States Tesla Full time

    What to ExpectTesla is seeking a highly motivated Sr. Packaging Engineer to join our Packaging team in developing world-class designs for use in high volume automation equipment. You will play a key role on the team and will be the one who brings it all together to drive technical execution of packaging projects across several Vehicle and Energy Product...

  • Sr. Process Engineer

    2 months ago

    Fremont, United States UCT Alumni Association Full time

    Join UCT and be part of the fastest-growing sector in the world! We indirectly touch every semiconductor chip that goes into every smartphone, smart car and device that uses artificial intelligence. This is a critical time for the semiconductor industry and for UCT - as technology evolves, we evolve with it. UCT is a diverse workplace where every talented...

  • Quality Resident Engineer

    3 days ago

    Fremont, United States TRIGO Global Quality Solutions Full time

    Job DescriptionJob DescriptionTRIGO Global Quality Solutions is seeking a Quality Resident Engineer/Automotive LiaisonFreemont, CAPart- to Full-time / $25/hourThis job is key for the success of TRIGO's Quality Resident Engineering business, so the following objectives should be accomplished to the highest feasible standards to avoid the official claims...

  • Quality Resident Engineer

    1 week ago

    Fremont, United States TRIGO Global Quality Solutions Full time $24 - $25

    Job DescriptionJob DescriptionTRIGO Global Quality Solutions is seeking a Quality Resident Engineer/Automotive LiaisonFreemont, CAPart- to Full-time / $24-25/hourThis job is key for the success of TRIGO's Quality Resident Engineering business, so the following objectives should be accomplished to the highest feasible standards to avoid the official...

  • Sr. Process Engineer

    2 months ago

    Fremont, United States Ultra Clean Technology Full time

    Join UCT and be part of the fastest-growing sector in the world! We indirectly touch every semiconductor chip that goes into every smartphone, smart car and device that uses artificial intelligence. This is a critical time for the semiconductor industry and for UCT - as technology evolves, we evolve with it. UCT is a diverse workplace where every talented...

  • Sr. Process Engineer

    1 month ago

    Fremont, United States UCT Alumni Association Full time

    Join UCT and be part of the fastest-growing sector in the world! We indirectly touch every semiconductor chip that goes into every smartphone, smart car and device that uses artificial intelligence. This is a critical time for the semiconductor industry and for UCT - as technology evolves, we evolve with it. UCT is a diverse workplace where every talented...

  • Sr. Process Engineer

    4 weeks ago

    Fremont, United States Ultra Clean Technology Systems & Svc Inc Full time

    Job DescriptionJob DescriptionJoin UCT and be part of the fastest-growing sector in the world! We indirectly touch every semiconductor chip that goes into every smartphone, smart car and device that uses artificial intelligence. This is a critical time for the semiconductor industry and for UCT - as technology evolves, we evolve with it. UCT is a diverse...

  • Sr. Process Engineer

    5 days ago

    Fremont, United States UCT Alumni Association Full time

    Join UCT and be part of the fastest-growing sector in the world! We indirectly touch every semiconductor chip that goes into every smartphone, smart car and device that uses artificial intelligence. This is a critical time for the semiconductor industry and for UCT - as technology evolves, we evolve with it. UCT is a diverse workplace where every talented...

  • Sr. Joining Engineer, Fremont Central Manufacturing Engineering

    1 week ago

    Fremont, United States Tesla Full time

    What to ExpectThe Sr. Joining Engineer position, reporting to the Joining Engineering Manager, is located at out Fremont Factory location. The primary responsibility of this role is to manage and launch joining engineering projects from design to start of production. The candidate should have expertise and experience in automotive manufacturing with a full...

  • Sr. BMC Engineer

    3 months ago

    Fremont, United States Aivres Full time

    About AivresAivres is a leading global data center and cloud computing solutions provider committed to delivering innovative technologies that propel the world’s leading industries to new frontiers. We deliver and deploy robust, performance-optimized, purpose-built platforms to major data centers around the globe.As a Sr. BMC (Baseboard Management...

  • Sr. BMC Engineer

    3 months ago

    Fremont, United States Aivres Full time

    About AivresAivres is a leading global data center and cloud computing solutions provider committed to delivering innovative technologies that propel the world’s leading industries to new frontiers. We deliver and deploy robust, performance-optimized, purpose-built platforms to major data centers around the globe.As a Sr. BMC (Baseboard Management...

  • Sr. Systems Engineer

    3 months ago

    Fremont, United States Aivres Full time

    About AivresAivres is a leading global data center and cloud computing solutions provider committed to delivering innovative technologies that propel the world’s leading industries to new frontiers. We deliver and deploy robust, performance-optimized, purpose-built platforms to major data centers around the globe.As a Sr. Systems Engineer, you will play a...