Senior Quality Technician

3 weeks ago

Menlo Park, United States Randstad Life Sciences US Full time

Exciting opportunity for a Senior Quality Technician to work with a growing biotechnology company focused on cancer screening and detection.


Primary responsibilities include completing required document reviews and material inspections, completing associated forms and other documents as part of Standard Operating Procedures and Work Instructions process requirements, in compliance with the EU In Vitro Diagnostic Regulation (IVDR), ISO 13485, ISO 14971, FDA 21 CFR 820 and related medical device regulations.


This individual is responsible for executing acceptance activities associated with receiving inspection and release of purchased items, and finished product inspection of internally manufactured items. These items (i.e., components, raw materials, and finished reagents) are processed in accordance with our medical device and clinical laboratory quality management system requirements. This person works closely with Supply Chain, Manufacturing Science & Technology (MSAT), Quality Control (QC), Development, Design Quality, and other teams to ensure compliance with procedures and product quality assurance is maintained. The person in this role consistently applies critical thinking skills and good judgment to solve focused problems.


Schedule/Shift: 1st shift, Mon.-Fri. 7:00/8:00am-4:00/5:00pm

Position Type: Contract-to-hire role


Essential Duties and Responsibilities:

  • Conduct quality inspections on incoming items, in-process production items, and finished products to ensure compliance with quality standards and specifications.
  • Collaborate with production teams and Quality Engineering teams to improve quality inspection procedures and processes.
  • Utilize quality systems and tools to track, analyze, and report on quality metrics.
  • Initiate and drive to completion thorough and correct nonconformance reports when quality issues are identified.
  • Coordinate with Supplier Quality and Supply Chain to resolve issues identified in quality inspection activities.
  • Support Quality Engineers in the conduct of root cause analysis and associated activities to address quality issues.


Qualifications:

  • High school diploma or GED required. Bachelor's degree (BS) in relevant science or engineering field preferred.
  • Five (5) years of experience working within medical device or pharmaceutical quality management systems (QMS), optimally with direct responsibilities for performing receiving inspection, in-process inspection, and finished product inspection.
  • Experience conducting quality inspections using various measurement tools and equipment, as well as reviewing paper and/or electronic documents and records including specifications, certificates of analysis, certificates of compliance, quality control test results, and device history records in compliance with standard operating procedures and work instructions.
  • Working knowledge and implementation of applicable medical device regulations and standards including but not limited to 21 CFR 820, ISO 13485, ISO 14971, MDR / IVDR.
  • Demonstrated expertise initiating and completing nonconformance reports and providing guidance and oversight to ensure appropriate segregation, identification, and ultimate material disposition (physical and electronic).
  • Experience working with software applications such as Enterprise Resource Planning (ERP), Laboratory Information Management Systems (LIMS), electronic quality management systems (eQMS), document management systems, and related tools.
  • Ability to analyze data and generate reports to communicate quality trends and issues.
  • Strong written and verbal communication skills.
  • Ability to comprehend and interpret technical information related to analytical methods, processes, and regulatory requirements


Preferred Skills and Experience:

  • Leadership or supervisory experience in receiving inspection and internal acceptance activities.
  • ASQ Certified Quality Technician, Certified Quality Engineer, or similar.

  • Senior Quality Technician

    7 days ago

    Menlo Park, United States Randstad Life Sciences US Full time

    Exciting opportunity for a Senior Quality Technician to work with a growing biotechnology company focused on cancer screening and detection. Primary responsibilities include completing required document reviews and material inspections, completing associated forms and other documents as part of Standard Operating Procedures and Work Instructions process...

  • Senior Quality Technician

    3 weeks ago

    Menlo Park, United States Randstad Life Sciences US Full time

    Exciting opportunity for a Senior Quality Technician to work with a growing biotechnology company focused on cancer screening and detection.Primary responsibilities include completing required document reviews and material inspections, completing associated forms and other documents as part of Standard Operating Procedures and Work Instructions process...

  • Senior Quality Manager

    7 hours ago

    Menlo Park, United States Element Energy Full time

    Element Energy is a dynamic startup company reimagining energy storage and battery management. Our breakthrough algorithms and our patented control systems solve critical battery safety and performance issues in the multi-billion-dollar large-scale grid storage and electric vehicle battery markets. Our products mitigate the risk of industry-threatening...

  • Senior Desktop Support

    1 month ago

    Menlo Park, United States Essel Environmental Full time

    Start your career with Essel! We are looking for a Senior Desktop Support to support one of our clients in Menlo park or San Francisco area. Do you have what it takes to take the next step?Job description:Update and maintain technology knowledgebase with customer facing and internal troubleshooting documentation Perform remote and on-site troubleshooting...

  • Senior Desktop Support

    1 month ago

    Menlo Park, United States Essel Full time

    Job DescriptionJob DescriptionStart your career with Essel! We are looking for a Senior Desktop Support to support one of our clients in Menlo park or San Francisco area. Do you have what it takes to take the next step? Job description:Update and maintain technology knowledgebase with customer facing and internal troubleshooting documentation Perform remote...

  • Quality Assurance Manager

    3 weeks ago

    Menlo Park, United States Harbourshare Full time

    Get notified about new Senior Marketing Engineer jobs in United States . Distinguished Software Engineer - LinkedIn Marketing Solutions Principal Engineer, Marketing Technologies Chief Engineer - Brand New AC Hotel - Clayton, Missouri Looking for Salesforce Marketing Cloud Engineer -Augusta, Charleston, Dallas, Meridian, Oakbrook Terrace, Princeton (Hybrid/...

  • Quality Technician

    7 days ago

    Franklin Park, United States Randstad North America, Inc. Full time

    Now hiring for Quality Technicians in Franklin Park, IL! 3rd Shift, M-F and Saturdays as needed. 11:00 PM to 7:00 AM Temp to Perm Opportunity! Experience Needed: Upload testing into computers/computer skills Identifying deviations in product Operatio Quality Technician, Technician, High School, Manufacturing, Staffing, Quality

  • Quality Technician

    2 weeks ago

    Bedford Park, United States Zing Recruiting Full time

    Job DescriptionJob DescriptionQuality Laboratory TechnicianZing Recruiting is partnered with a global flavors and fragrance manufacturer specializing in vegetable products in seeking a Quality laboratory technician to join the quality department in testing and promoting quality control in the plant. The Quality technician in the quality team will join an...

  • Quality Technician

    2 weeks ago

    Bedford Park, United States Zing! Recruiting Full time

    Job DescriptionJob DescriptionQuality Laboratory TechnicianZing Recruiting is partnered with a global flavors and fragrance manufacturer specializing in vegetable products in seeking a Quality laboratory technician to join the quality department in testing and promoting quality control in the plant. The Quality technician in the quality team will join an...

  • Head of Quality Assurance

    7 hours ago

    Menlo Park, United States Oruka Tx Full time

    About Us: Oruka Therapeutics is a newly launched company whose mission is to restore skin health. We were founded by well-known investors at Fairmount Funds, in the same model as Apogee Therapeutics and Spyre Therapeutics which together have raised $700M+ over the past two years and have made successful public debuts. We have a lead program that we expect...

  • Head of Regulatory Affairs and Quality

    4 weeks ago

    Menlo Park, United States Russell Solutions Group Full time

    Job DescriptionJob DescriptionHead of Regulatory Affairs and QualityAbout This Role:We are seeking an experienced Head of RA/QA to support U.S. regulatory activities as well as be an individual contributor on regulatory projects. The Head of RA/QA will participate in he planning, development and execution of regulatory submissions. The incumbent will drive...

  • Engineering Technician I/II

    24 hours ago

    Menlo Park, United States Menlo Park Full time

    Menlo Park is a city of beautiful, tree-lined neighborhoods and active commercial districts. Located conveniently between the major metropolitan areas of San Francisco and San Jose, Menlo Park is home to just approximately 32,000 residents in its 19 square miles. The stunning natural surroundings of the city afford views of the San Francisco Bay to the east...

  • Pharmacy Technician

    2 days ago

    Menlo Park, United States CVS Health Full time

    Bring your heart to CVS Health. Every one of us at CVS Health shares a single, clear purpose: Bringing our heart to every moment of your health. This purpose guides our commitment to deliver enhanced human-centric health care for a rapidly changing world. Anchored in our brand — with heart at its center — our purpose sends a personal message that how we...

  • Nail Technician

    2 weeks ago

    La Grange Park, United States Plymouth Place Senior Living Full time

    Plymouth Place is a Premier Senior Living location. We are seeking a nail tech with exceptional nail care services. We pride ourselves on creating a welcoming, relaxing atmosphere where clients can indulge in high-quality beauty treatments. We are currently looking for a talented and passionate Nail Technician to join our team.Responsibilities:Provide...

  • Senior Marketing Program Manager

    15 hours ago

    Menlo Park, United States Planet Interactive Full time

    Senior Marketing Program Manager Pay Rate: Up to $115/hr depending on location and experience Location: 100% onsite in Menlo Park, CA Duration: 7 Months Our well-known Technology client is seeking an experienced Senior Marketing Program Manager to join their team. Marketing Program Manager Responsibilities Accomplishes marketing human resource objectives by...

  • Quality Technician

    7 days ago

    Franklin Park, United States Carlisle Construction Materials Full time

    Carlisle Construction Materials (CCM), is a global leader in the building materials industry. Weve been around since 1917. In just the past six years, our company has grown by nearly 70%. We are looking for a Quality Technician to join our team in our Franklin Park, IL facility. The Quality Technician will be responsible for testing of finished product...

  • Quality Technician

    3 weeks ago

    Franklin Park, United States Carlisle SynTec Full time

    Job DescriptionCarlisle Construction Materials (CCM), is a global leader in the building materials industry. We’ve been around since 1917. In just the past six years, our company has grown by nearly 70%. We are looking for a Quality Technician to join our team in our Franklin Park, IL facility. The Quality Technician will be responsible for testing of...

  • Quality Technician

    4 weeks ago

    Franklin Park, United States Carlisle Construction Materials Full time

    Carlisle Construction Materials (CCM), is a global leader in the building materials industry. We’ve been around since 1917. In just the past six years, our company has grown by nearly 70%.We are looking for a Quality Technician to join our team in our Franklin Park, IL facility. The Quality Technician will be responsible for testing of finished product...

  • Quality Technician

    4 weeks ago

    Franklin Park, United States Carlisle Construction Materials Full time

    Carlisle Construction Materials (CCM), is a global leader in the building materials industry. We’ve been around since 1917. In just the past six years, our company has grown by nearly 70%.We are looking for a Quality Technician to join our team in our Franklin Park, IL facility. The Quality Technician will be responsible for testing of finished product...

  • Quality Technician

    3 weeks ago

    Franklin Park, United States Carlisle Construction Materials Full time

    Carlisle Construction Materials (CCM), is a global leader in the building materials industry. We’ve been around since 1917. In just the past six years, our company has grown by nearly 70%.We are looking for a Quality Technician to join our team in our Franklin Park, IL facility. The Quality Technician will be responsible for testing of finished product...