What are the responsibilities and job description for the Sr Quality Engineer position at Imperative Care Inc?
SUMMARY/RESPONSIBILITIES:
This position provides Quality Engineering support in the development, manufacture, and distribution of Imperative Care’s medical device products consistent with the Company’s Quality Policy and Quality Objectives.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned on an individual basis:
- Responsible for 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.
- Lead training on the use of procedures to promote compliance with Quality System and Regulations to a broad audience.
- Liaison with laboratories to conduct routine product testing or root cause analysis related to testing failures or deviations.
- Conduct methodical root cause investigations and provide guidance on actions necessary to prevent recurrence.
- Direct interaction with suppliers to qualify and maintain approved supplier status. May be required to 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.
- Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA/MDD regulations.
- May provide quality metric data to various functional groups within the organization.
- Actively promote and support the Quality Management System, Quality Objectives, and Quality Policy.
- Assure that you and functional subordinates (if applicable) are trained on all applicable procedures and processes according to Good Manufacturing Practices, applicable FDA and Regulatory requirements.
- Actively promote and support the company’s Management Review process.
- Inform responsible personnel of concerns involving product quality.
- Perform job functions in a safe and effective manner.
- Other duties as assigned
EDUCATION/EXPERIENCE:
- BS in Engineering or related discipline and 5 years of related experience; or MS in Engineering with 3 years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry Experience with development and validation of test methods to comply with recognized standards
- Experience working with catheters, endovascular or neurological devices highly desired
- Experience addressing supplier or process issues (CAPAs, NCMR/NCRs, SCARs, etc.)
- Must be knowledgeable about 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)
- Must be able to provide thorough and meticulous review of documents
- Must be able to write clear, concise, and well thought out technical documentation with a focus on failure investigations and inspection procedures
- Must be able to perform multiple tasks concurrently with accuracy
- Proficiency with Microsoft Office products
