Quality Engineer

4 weeks ago

Irvine, United States TalentBurst Full time

Position: Quality Engineer II (Complaint Investigations), Req#: 6085-1
Location: Irvine, CA (100% onsite)

Duration: 3 Months Contract

Job Description: 

This position will be in THV Quality Engineering, Global Product Surveillance (GPS). The GPS team is responsible for leading and performing critical engineering investigations on globally reported complaints for returned/non-returned devices. The role is not remote and will require a presence on campus.

This opening is with the THV quality engineering team. The team of 23 engineers and technicians handles about 80 to 100 complaints per week. As a member of this team, you will have the opportunity to interact with domestic and global medical teams/clients.

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and the client’s systems/procedures for device investigation and risk assessments of reported complaints from the field.

Education and Experience: 

  • Bachelor's Degree or equivalent in Engineering or Scientific field, 2 years of experience related to work experience required; or Master's Degree or equivalent in Engineering or Scientific field, 1-year experience including either industry or industry/education required.
  • Proficient with the Microsoft Office suite
  • Experience with medical device complaint investigations (CAPA's, NCR's, and Root-Cause Analysis)
  • Functional, physical, and visual testing of medical device equipment in a laboratory setting
  • Experience in medical devices (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred.
  • Experience in complaint investigations, root cause analysis, and the associated risk assessments preferred.
  • Preference is for candidates to have some complaint investigation experience/root cause analysis. Another preference is for medical device experience.

Additional Skills:

  • Good documentation, communication, and interpersonal relationship skills including negotiating and relationship management skills.
  • Basic understanding of statistical techniques
  • Previous experience working with lab/industrial equipment required
  • Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
  • Solid problem-solving, organizational, analytical, and critical thinking skills
  • Solid understanding of processes and equipment used in assigned work
  • Knowledge of and adherence to Quality systems
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast-paced environment
  • Must be able to work in a team environment, including the ability to manage project stakeholders
  • Ability to build productive internal/external working relationships

Roles and Responsibilities: 

  • Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
  • Perform hands-on device investigation using visual, dimensional, and test equipment to determine the root cause.

Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed.

  • Participate in escalation tasks and activities, including Project Risk Assessments (PRA) and Corrective/Preventive action(s) – CAPAs, SCARs, as determined by the investigation.
  • Identify and report key complaint metrics per device category and collaborate with applicable manufacturing engineering teams to resolve production/device-related issues.
  • Other incidental duties assigned by Leadership (May assist in Adhoc complaint analysis or metric review).

TB_EN

  • Engineering - Quality Engineer

    3 weeks ago

    Irvine, United States Jnd Corp Full time

    Position OverviewJob Title: Engineering - Quality Engineer 3 Job Type: Regular Full-Time, HourlyBachelor's degree and related experience preferred LocationIrvine, CA BenefitsMedical Insurance (Health, Dental & Vision)401(k) with Company MatchPaid Time OffH1B/Green Card Sponsorship for qualified employeeHands-on experience at global industry leader...

  • Quality Engineer

    1 week ago

    Irvine, United States JobRialto Full time

    Job Description: Summary: The main function of a quality engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical quality engineer has the ability to make engineering drawings, write risk analysis documents and read and interpret drawings.Job Responsibilities:Applies knowledge of quality...

  • Quality Engineer

    4 weeks ago

    Irvine, United States TalentBurst, an Inc 5000 company Full time

    Position: Quality Engineer I (Complaint Investigations), Req#: 6086-1Position: Quality Engineer II (Complaint Investigations), Req#: 6085-1 Both are short-term (3 months only with no possibility of extension/conversion) contract jobs.Position: Quality Engineer I/II (Complaint Investigations)Location: Irvine, CA (100% onsite)Duration: 3 Months ContractJob...

  • Quality Engineer

    4 weeks ago

    Irvine, United States TalentBurst, an Inc 5000 company Full time

    Position: Quality Engineer I (Complaint Investigations), Req#: 6086-1Position: Quality Engineer II (Complaint Investigations), Req#: 6085-1 Both are short-term (3 months only with no possibility of extension/conversion) contract jobs.Position: Quality Engineer I/II (Complaint Investigations)Location: Irvine, CA (100% onsite)Duration: 3 Months ContractJob...

  • Quality Engineer

    4 weeks ago

    Irvine, United States TalentBurst, an Inc 5000 company Full time

    Position: Quality Engineer I (Complaint Investigations), Req#: 6086-1Position: Quality Engineer II (Complaint Investigations), Req#: 6085-1 Both are short-term (3 months only with no possibility of extension/conversion) contract jobs.Position: Quality Engineer I/II (Complaint Investigations)Location: Irvine, CA (100% onsite)Duration: 3 Months ContractJob...

  • Engineering - Quality Engineer

    2 weeks ago

    Irvine, United States Jnd Corp Full time

    Position OverviewJob Title: Engineering - Quality Engineer 3 Job Type: Regular Full-Time, Hourly Bachelor's degree and related experience preferred Location Irvine, CA Benefits Medical Insurance (Health, Dental & Vision) 401(k) with Company Match Paid Time Off H1B/Green Card Sponsorship for qualified employee Hands-on experience at global industry...

  • Quality Engineer

    3 weeks ago

    Irvine, United States Actalent Full time

    For immediate consideration, please apply directly to this job posting AND email biacosta @ actalentservices.com with the following: 1) Word copy of resume 2) 4-5 brief bullet points highlighting technical qualifications Description: Looking for a Quality Engineer that can support and eventually run the Quality duties for the site and grow into a Quality...

  • Quality Engineer

    3 weeks ago

    Irvine, United States TalentBurst Inc Full time

    Position: Quality Engineer II (Complaint Investigations), Req#: 6085-1Location: Irvine, CA (100% onsite)Duration: 3 Months ContractThis position will be in THV Quality Engineering, Global Product Surveillance (GPS). The GPS team is responsible for leading and performing critical engineering investigations on globally reported complaints for...

  • Quality Engineer

    3 weeks ago

    Irvine, United States TalentBurst, an Inc 5000 company Full time

    Position: Sr. Quality Engineer, Req#: 6948-1Location: Irvine, CA (100% onsite) Duration: 9+ Months Contract Job Description:The main function of a quality engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical quality engineer can make engineering drawings, write risk analysis documents...

  • Quality Engineer

    3 weeks ago

    Irvine, United States TalentBurst, an Inc 5000 company Full time

    Position: Sr. Quality Engineer, Req#: 6948-1Location: Irvine, CA (100% onsite) Duration: 9+ Months Contract Job Description:The main function of a quality engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical quality engineer can make engineering drawings, write risk analysis documents...

  • Quality Engineer

    1 week ago

    Irvine, United States TalentBurst, an Inc 5000 company Full time

    Position: Sr. Quality Engineer, Req#: 6948-1Location: Irvine, CA (100% onsite) Duration: 9+ Months Contract Job Description:The main function of a quality engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical quality engineer can make engineering drawings, write risk analysis documents...

  • Quality Engineer

    2 weeks ago

    Irvine, United States Motion Recruitment Full time

    We are looking for a Quality Engineer to ensure regulatory compliance and optimize product development and manufacturing. It requires a bachelor's degree in engineering, 5-7 years of experience, and skills in CAD, communication, and problem-solving.Job Responsibilities:Applies knowledge of quality engineering principles and methods to ensure compliance with...

  • Quality Engineer

    1 week ago

    Irvine, United States Motion Recruitment Full time

    We are looking for a Quality Engineer to ensure regulatory compliance and optimize product development and manufacturing. It requires a bachelor's degree in engineering, 5-7 years of experience, and skills in CAD, communication, and problem-solving.Job Responsibilities:Applies knowledge of quality engineering principles and methods to ensure compliance with...

  • Quality Engineer

    3 weeks ago

    Irvine, California, United States TalentBurst Inc Full time

    Position: Quality Engineer II (Complaint Investigations), Req#: 6085-1Location: Irvine, CA (100% onsite)Duration: 3 Months ContractThis position will be in THV Quality Engineering, Global Product Surveillance (GPS). The GPS team is responsible for leading and performing critical engineering investigations on globally reported complaints for...

  • Quality Engineer

    2 weeks ago

    Irvine, California, United States TalentBurst Inc Full time

    Position: Quality Engineer II (Complaint Investigations), Req#: 6085-1Location: Irvine, CA (100% onsite)Duration: 3 Months ContractThis position will be in THV Quality Engineering, Global Product Surveillance (GPS). The GPS team is responsible for leading and performing critical engineering investigations on globally reported complaints for...

  • Quality Engineer

    3 weeks ago

    Irvine, United States TalentBurst, an Inc 5000 company Full time

    Short-term (3 months only with no possibility of extension/conversion) contract jobs.Position: Quality Engineer I (Complaint Investigations/ Post Market Surveillance), Req#: 6086-1 Location: Irvine, CA (100% onsite)Duration: 3 Months ContractJob Description: This position will be in THV Quality Engineering, Global Product Surveillance (GPS). The GPS team is...

  • Quality Engineer

    3 weeks ago

    Irvine, United States TalentBurst, an Inc 5000 company Full time

    Short-term (3 months only with no possibility of extension/conversion) contract jobs.Position: Quality Engineer I (Complaint Investigations/ Post Market Surveillance), Req#: 6086-1 Location: Irvine, CA (100% onsite)Duration: 3 Months ContractJob Description: This position will be in THV Quality Engineering, Global Product Surveillance (GPS). The GPS team is...

  • Quality Engineer

    2 weeks ago

    Irvine, United States TalentBurst, an Inc 5000 company Full time

    Short-term (3 months only with no possibility of extension/conversion) contract jobs.Position: Quality Engineer I (Complaint Investigations/ Post Market Surveillance), Req#: 6086-1 Location: Irvine, CA (100% onsite)Duration: 3 Months ContractJob Description: This position will be in THV Quality Engineering, Global Product Surveillance (GPS). The GPS team is...

  • Quality Engineer

    3 weeks ago

    Irvine, United States TalentBurst, an Inc 5000 company Full time

    Short-term (3 months only with no possibility of extension/conversion) contract jobs.Position: Quality Engineer I (Complaint Investigations/ Post Market Surveillance), Req#: 6086-1 Location: Irvine, CA (100% onsite)Duration: 3 Months ContractJob Description: This position will be in THV Quality Engineering, Global Product Surveillance (GPS). The GPS team is...

  • Quality Engineer

    1 week ago

    Irvine, United States TalentBurst, an Inc 5000 company Full time

    Short-term (3 months only with no possibility of extension/conversion) contract jobs.Position: Quality Engineer I (Complaint Investigations/ Post Market Surveillance), Req#: 6086-1 Location: Irvine, CA (100% onsite)Duration: 3 Months ContractJob Description: This position will be in THV Quality Engineering, Global Product Surveillance (GPS). The GPS team is...