Quality Engineer, II

Imperative Care • Campbell, CA

74d • Onsite

About The Position

As a professional in this field, this position will use solid knowledge and experience and contribute to the development, manufacture, and distribution of Imperative Care’s medical device products by applying Quality Engineering principles to all applicable processes and procedures in accordance with the Company’s Quality Policy and Quality Objectives. Provide quality input to define required validations necessary to support significant process changes on commercially launched products. Collaborate with team members to define validation requirements, specifications, testing, and component/product acceptance activities. Analyse data by completing hypothesis, normal distribution, and process capability analysis tests intended to provide input on the quality of the product/process being evaluated/monitored. Create and revise quality assurance procedures, as required, to maintain compliance to changing regulations and guidance documents. Train broad audience on the use of procedures to comply with Quality Systems and Regulations. Serve as liaison with laboratories conducting routine product testing or root cause analysis related to testing failures or deviations. Conduct methodical root cause investigations and provide guidance to prevent recurrence. Work with suppliers to qualify and maintain approved supplier status. May evaluate supplier notification of change and recommend necessary actions to maintain compliance. Perform statistical analysis of manufacturing data and quality processes and creation of reports based on quality documentation. Review DCO’s involving product or process changes to ensure consistency with company procedures and quality system compliance. Conduct and review Risk Management assessments on product and process changes. Conduct failure mode effect analysis on product. Support projects (including product enhancements) in an aggressive manner consistent with corporate objectives. May provide quality metric data to various functional groups within the organization.

Requirements

• Bachelor’s degree in engineering, or related discipline and a minimum of 1 year of related experience; or equivalent combination of education and work experience
• Experience addressing supplier or process issues (CAPAs, NCMR/NCRs, SCARs, etc.).
• Demonstrated knowledge of quality system requirements (FDA 21 CFR Part 820, ISO 13485 or ISO 9001), risk management standards (ISO 14971) and good manufacturing practices.
• Excellent communications skills (both written and verbal).
• Proven ability to provide thorough and meticulous review of documents.
• Proven ability to write clear, concise, and well thought out technical documentation with focus on failure investigations and inspection procedures.
• Strong ability to perform multiple tasks concurrently with accuracy.
• Proficiency with Microsoft Office products.

Nice To Haves

• Advanced degree and experience with catheters, endovascular/neurological devices is highly desired.

Responsibilities

• Provide quality input to define required validations necessary to support significant process changes on commercially launched products.
• Collaborate with team members to define validation requirements, specifications, testing, and component/product acceptance activities.
• Analyse data by completing hypothesis, normal distribution, and process capability analysis tests intended to provide input on the quality of the product/process being evaluated/monitored.
• Create and revise quality assurance procedures, as required, to maintain compliance to changing regulations and guidance documents.
• Train broad audience on the use of procedures to comply with Quality Systems and Regulations.
• Serve as liaison with laboratories conducting routine product testing or root cause analysis related to testing failures or deviations.
• Conduct methodical root cause investigations and provide guidance to prevent recurrence.
• Work with suppliers to qualify and maintain approved supplier status. May evaluate supplier notification of change and recommend necessary actions to maintain compliance.
• Perform statistical analysis of manufacturing data and quality processes and creation of reports based on quality documentation.
• Review DCO’s involving product or process changes to ensure consistency with company procedures and quality system compliance.
• Conduct and review Risk Management assessments on product and process changes.
• Conduct failure mode effect analysis on product.
• Support projects (including product enhancements) in an aggressive manner consistent with corporate objectives.
• May provide quality metric data to various functional groups within the organization.

Benefits

• Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees