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QUALITY ASSURANCE CAPA INVESTIGATOR
Job Field: Legal Jobs
Location: Fremont, CA
Salary: $Not stated
Location: Fremont, CA
Salary: $Not stated
JOB SUMMARY:
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<tr><td valign="top" width="450"><b>Quality Assurance CAPA Investigator Job ID: FM20122008-98325 Requirements:Expertise Quality AssuranceEducation BachelorsJob Type Full-timeLocation United States - California - FremontJob Level Entry LevelDescription:Position Summary:Conduct Nonconformance and CAPA investigations. Review investigation plans, corrective and preventive plans, design studies for trouble shooting, and reports. Key Responsibilities:* Support investigations on issues generated by nonconformities, customer complaints, SCARs, and Audit findings.* Assist with the risk assessment process and evaluating product impact.* Analyze and organize data from multiple sources by utilizing statistical tools to identify trends and recommend updates or changes when necessary.* Provide support on Nonconformance and CAPA investigations by providing data analysis tools and assistance.* Utilize company policies and procedures to review and make recommendations on corrective and preventative action plans.* Assist in training production personnel as needed.* Support CAPA investigation activities and coordinate CAPA board review meetings.Minimum Requirements/Qualifications:* Bachelor’s degree in Chemistry, Biochemistry, and Biology related field* 2 - 5 years of related work experience, preferably in the quality assurance/quality control department with IVD production.* Understand Clinical Chemistry products, production process and documentation requirements.* Experience investigating nonconforming events using basic statistical and data analysis skills.* Experience participating on cross-functional teams.* Excellent organizational and multi-tasking skills.Non-Negotiable Hiring Criteria:* Solid understanding of 21CFR 820 and ISO 13485 regulations for medical devices.* Excellent writing and verbal communication skills.* Experience in risk assessment/management.
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<tr><td valign="top" width="450"><b>Quality Assurance CAPA Investigator Job ID: FM20122008-98325 Requirements:Expertise Quality AssuranceEducation BachelorsJob Type Full-timeLocation United States - California - FremontJob Level Entry LevelDescription:Position Summary:Conduct Nonconformance and CAPA investigations. Review investigation plans, corrective and preventive plans, design studies for trouble shooting, and reports. Key Responsibilities:* Support investigations on issues generated by nonconformities, customer complaints, SCARs, and Audit findings.* Assist with the risk assessment process and evaluating product impact.* Analyze and organize data from multiple sources by utilizing statistical tools to identify trends and recommend updates or changes when necessary.* Provide support on Nonconformance and CAPA investigations by providing data analysis tools and assistance.* Utilize company policies and procedures to review and make recommendations on corrective and preventative action plans.* Assist in training production personnel as needed.* Support CAPA investigation activities and coordinate CAPA board review meetings.Minimum Requirements/Qualifications:* Bachelor’s degree in Chemistry, Biochemistry, and Biology related field* 2 - 5 years of related work experience, preferably in the quality assurance/quality control department with IVD production.* Understand Clinical Chemistry products, production process and documentation requirements.* Experience investigating nonconforming events using basic statistical and data analysis skills.* Experience participating on cross-functional teams.* Excellent organizational and multi-tasking skills.Non-Negotiable Hiring Criteria:* Solid understanding of 21CFR 820 and ISO 13485 regulations for medical devices.* Excellent writing and verbal communication skills.* Experience in risk assessment/management.
KEY REQUIREMENTS:
Not stated
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