Quality Engineer II

Position: Quality Engineer II

Location: San Diego, CA

Duration: 12+ Months Contract

Total Hours/week: 40.00
On-Site

Description:
Assignment duration: Role is estimated to be 1 year duration and we expectation an extension of contract into year 2.

3 must haves on resume: ISO 13485 Quality Systems Regulations, cleanroom validation studies and environmental monitoring and critical systems (ie processed water and compressed air) monitoring, Experience with product bioburden monitoring

We do not need someone with “clinical microbiology experience”. We need someone with industrial (medical device, Pharma, or biotech) experience.

Education and Experience:
BS Biological Sciences, Chemistry, Bio-tech engineering, Bio-engineering or related field
Minimum of 3-5 years of experience in Medical Device, Biotech or Pharma Industry.

Job Summary:
As directed by the Quality Engineering Leader, the Quality Engineer IIs accountable for supporting cleanroom validation, environmental monitoring, and product bioburden testing. Successful performance requires close work with quality management, operations, and/or BD associates to assure compliance with all BD quality policies, procedures, and practices.
Must demonstrate a working understanding of the ISO 13485 Quality Systems Regulations, ISO 14644 series and ISO 11737. Preferred core experience in Quality Assurance, Quality Control, Validation (IQ,OQ,PQ). Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance.
Job Responsibilities: (Primary Duties, Roles, and/or Authorities)
1. Experience with addressing any internal quality issues and help team to resolve it in timely manner with production, quality, and regulatory compliance need. Part of MRB team to help team to create or drive quality notification to release the material.
2. Experience performing equipment and process validation studies such as writing and/or reviewing protocol, report, data analysis and deviations for new, existing and site relocation activities. Have a working knowledge of medical device or biological equipment maintenance from Quality standpoint such as Preventive Maintenance, Calibration and Out Of Tolerance activity support to the site and equipment owners.
3. Experience on CAPA (Corrective Action and Preventive Action) for internal and external complaints or Non conformance or continuous improvement activities.
4. Experience with cleanroom validation studies and environmental monitoring and critical systems (ie processed water and compressed air) monitoring.
5. Experience with product bioburden monitoring and microbial testing methods.

Knowledge and Skills:
1. Strong verbal and written communication skills; ability to write technical documents. Knowledge of quality system methodologies
2. Statistical Analysis basic knowledge e.g Minitab or Excel
3. Strong knowledge of Design Control, Process Validation and Supplier Management
4. Strong understanding and knowledge on ISO 9001, ISO 14644, 11737, and/or ISO 13485 (Design Control,
5. SAP knowledge
6. The ability to work in teams and independently with minimal supervision to obtain results as required.
7. Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects.

Physical Demands: (if applicable)
1. General physical requirements: Sedentary work
2. Visual acuity requirements: Inspection / Administrative.
3. Motion and sensory requirements: Talking, hearing, and walking.

Work Environment: (if applicable)
1. Onsite
2. Ability to be present in manufacturing area as needed to support quality investigation.