MillenniumSoft Inc
Overview
Quality Engineer
role at
MillenniumSoft Inc . Location:
San Diego, CA ; Duration:
12 Months ; Employment Type:
Contract on W2 ; Level:
Mid-Level ; Hours per week:
40 ; Shift:
1st Shift . Responsibilities
As directed by the Quality Engineering Leader, the Quality Engineer II is accountable for validation execution for manufacturing equipment and support in process validation or verification studies. Collaborate with quality management, operations, suppliers and client associates to assure compliance with client quality policies, procedures, and practices. Demonstrate working understanding of ISO 13485 Quality System Regulations for Class I/II/II medical devices. Preferred experience in Quality Assurance, Quality Control, Validation (IQ, OQ, PQ) and Nonconformance management under GMP ISO FDA guidelines. Develop solutions to problems of moderate scope and complexity using applicable policies and procedures. Experience performing equipment and process validation studies, including writing and/or reviewing protocol, report, data analysis and deviations for new, existing and site relocation activities. Knowledge of preventive maintenance, calibration and Out Of Tolerance support for medical device or biological equipment from a quality perspective. Author and execute installation, operational, and performance qualifications for analytical and manufacturing equipment; validate GMP equipment and functions facility wide. Review and update FMEA or risk documents as needed for validation activities. Support business continuity during relocation of manufacturing processes to new areas and assist with QA inspections and batch record reviews for finished product release. Education And Experience
BS Biological Sciences, Chemistry, Bio-tech engineering, Bio-engineering or related field Minimum of 3-5 years of experience for QE II and 5-7 years for Sr. QE in Medical Device, Biotech or Pharma Industry. Knowledge And Skills
Strong verbal and written communication skills; ability to write technical documents. Knowledge of quality system methodologies Statistical Analysis basic knowledge e.g. Minitab or Excel Strong knowledge of Process Validation and equipment validation Strong understanding and knowledge on ISO 9001, ISO 14971 and/or ISO 13485 (Design Control, Supplier Management and Risk Management) Hands on experience using Six Sigma methodology SAP knowledge Equipment management system such as BMRAM knowledge preferred The ability to work in teams and independently with minimal supervision to obtain results as required. Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects. Physical Demands
General physical requirements: ability to work in controlled environment Ability to work with laboratory grade equipment such as refrigerators, freezers, centrifuges, etc during validation work. Work Environment
Onsite model Ability to be present in manufacturing area as needed
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Quality Engineer
role at
MillenniumSoft Inc . Location:
San Diego, CA ; Duration:
12 Months ; Employment Type:
Contract on W2 ; Level:
Mid-Level ; Hours per week:
40 ; Shift:
1st Shift . Responsibilities
As directed by the Quality Engineering Leader, the Quality Engineer II is accountable for validation execution for manufacturing equipment and support in process validation or verification studies. Collaborate with quality management, operations, suppliers and client associates to assure compliance with client quality policies, procedures, and practices. Demonstrate working understanding of ISO 13485 Quality System Regulations for Class I/II/II medical devices. Preferred experience in Quality Assurance, Quality Control, Validation (IQ, OQ, PQ) and Nonconformance management under GMP ISO FDA guidelines. Develop solutions to problems of moderate scope and complexity using applicable policies and procedures. Experience performing equipment and process validation studies, including writing and/or reviewing protocol, report, data analysis and deviations for new, existing and site relocation activities. Knowledge of preventive maintenance, calibration and Out Of Tolerance support for medical device or biological equipment from a quality perspective. Author and execute installation, operational, and performance qualifications for analytical and manufacturing equipment; validate GMP equipment and functions facility wide. Review and update FMEA or risk documents as needed for validation activities. Support business continuity during relocation of manufacturing processes to new areas and assist with QA inspections and batch record reviews for finished product release. Education And Experience
BS Biological Sciences, Chemistry, Bio-tech engineering, Bio-engineering or related field Minimum of 3-5 years of experience for QE II and 5-7 years for Sr. QE in Medical Device, Biotech or Pharma Industry. Knowledge And Skills
Strong verbal and written communication skills; ability to write technical documents. Knowledge of quality system methodologies Statistical Analysis basic knowledge e.g. Minitab or Excel Strong knowledge of Process Validation and equipment validation Strong understanding and knowledge on ISO 9001, ISO 14971 and/or ISO 13485 (Design Control, Supplier Management and Risk Management) Hands on experience using Six Sigma methodology SAP knowledge Equipment management system such as BMRAM knowledge preferred The ability to work in teams and independently with minimal supervision to obtain results as required. Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects. Physical Demands
General physical requirements: ability to work in controlled environment Ability to work with laboratory grade equipment such as refrigerators, freezers, centrifuges, etc during validation work. Work Environment
Onsite model Ability to be present in manufacturing area as needed
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