Job Description

• Take on full responsibility for the coordination and management of all equipment and process IQ’s, OQ’s and PQ’s
• Monitor and improve BIOVIC’s manufacturing processes with respect to yield and throughput
• Coordinate and manage all production process validations
• Coordinate and manage process validations of new products and line extensions
• Assist with increasing production capacity by streamlining and wherever possible automating manufacturing processes
• Keep all process FMEAs up to date

Job Requirements

• Candidate must have at a minimum a bachelor’s degree in an engineering or science discipline
• At least 4-5 years’ work experience in this field required; medical device background preferred
• Experience with ISO 13485 quality system is required, product/process FMEA will be a plus
• Must be able to understand and familiarize oneself with company’s multi-step manufacturing process (training will be provided).
• Must be familiar with writing and performing equipment and process IQ’s, OQ’s and PQ’s
• Must be familiar with writing and running process validations
• Must be comfortable with basic statistics and statistical software, familiarity with Design of Experiments is preferred
• Must demonstrate proficiency with following SOP’s, and must have good attention to detail.
• All protocols and reports must be in English, as such excellent spoken & written English skills are required.
• A diverse skillset is preferred as we work as a team, and may need to assist other departments

Skills