Quality Engineer

Quality Engineer role at Millennium Soft Inc
.

Location:

San Diego, CA
;
Duration:
12 Months
;

Employment Type:

Contract on W2
;
Level:
Mid-Level
;
Hours per week:
40
;

Shift:
1st Shift
.

• 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.

• 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.

• 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.

• 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.

• Onsite model
• Ability to be present in manufacturing area as needed