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Quality Engineer Manager

Company: Teknova
Location: Hollister
Posted on: April 9, 2021

Job Description:

OVERVIEWThe Quality Engineering Manager is responsible for leading Validation and Qualification activities, including equipment and system software. Approval of IQ/OQ/PQ's for equipment and or software as needed. SME for deign controls and working with R&D, and Mfg. Engineering. Write test method validations as needed for in-process and finished product for chemicals, and medical device components. Ability to calculate and or perform Cpk, Standard Deviations, and perform Data Analysis Review, and Trending as required. Responsible for equipment related and or product-related root cause analysis, process flow, and mapping. including impact assessment. Generate Change Orders as needed.
DUTIES AND RESPONSIBILITIES--- Understand and Approve IQ/OQ/PQ of Equipment for Validation and or Qualification of such equipment and or software.--- Develop and revise procedures, and processes as required for performing design, and failure investigations, --- Strong Risk Management understanding, including Fault Tree Analysis, and related systems--- Develop Design for Product, including risk assessments: FMEA, PFMEA, and UFMEA --- Generate Test Methods, and Validate such methods.--- Equipment Validation and Qualification including but not limited to reliability studies.--- Understanding various Tools & Equipment, Preventive Maintenance, Calibrations and Validations --- Perform various tasks as assigned by all levels of personnel --- Assisting in corrective and preventative actions --- Develop strong inter-departmental working relationships with Manufacturing Engineering, and R&D.--- Generate, review, and close reports for Quality Systems including chair meetings when required.--- Create work flowcharts, including SPC where applicable.--- Serve on Project Teams to provide SME QA support and approval for manufacturing processes, including equipment. --- Effectively Manage a team of Engineers & Technicians --- Work on occasion in a cleanroom regarding equipment and or software, following required PPE requirements.--- Demonstrate good judgment, and decision making as determined by management--- Comply with all Safety requirement.--- Report any observed unsafe equipment, condition or practice immediately to a supervisor, management, or member of the Safety Committee.--- Adhere to Quality System procedures and the ISO 13485, and CFR 820 or current regulatory standards.
EDUCATION--- Bachelor's Degree in Engineering, Biology, or related field, or equivalent combination of education and experience
KNOWLEDGE / SKILLS / EXPERIENCE--- Minimum 8 years experience in a Quality Engineering Role at a Medical Device, Pharmaceutical, or Biotech Company--- Knowledge of and functional understand requirements for ISO 13485, 21 CFR 820 and other applicable regulations such as ISO 14971--- Ability to handle multiple projects concurrently --- Must be able to walk, bend, carry, lift, push and pull 45 pounds --- 3 years specific experience with equipment design, qualification, including software validation preferred.
EEOC Employer

Keywords: Teknova, Salinas , Quality Engineer Manager, Executive , Hollister, California

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