What are the responsibilities and job description for the Senior Engineer, Quality position at JenaValve Technology, Inc.?
Description
Job Title: Senior Engineer, Quality
Supervisor/Manager Title: Global Director, Quality Assurance
Job Description Summary: Provide Quality Engineering support to various areas including design verification and validation, production line/receiving inspection support, process validation (IQ/OQ/PQ), process optimization, non-conformance investigation, risk management, and post-market assessment.
Job Responsibilities
Required Education and Experience:
Job Title: Senior Engineer, Quality
Supervisor/Manager Title: Global Director, Quality Assurance
Job Description Summary: Provide Quality Engineering support to various areas including design verification and validation, production line/receiving inspection support, process validation (IQ/OQ/PQ), process optimization, non-conformance investigation, risk management, and post-market assessment.
Job Responsibilities
- Partner with Manufacturing Engineers to develop and qualify manufacturing processes.
- Review and approve design changes.
- Provide technical Quality support to ensure new processes/procedures are in compliance with the governing standards and procedures.
- Provide technical Quality support during review of the standards.
- Review of documentation and production records to ensure all product is produced in a compliant manner and ensure all manufacturing records received are reviewed, approved, and filed in compliance with QSRs and ISO standards.
- Creation and approval of test protocols and reports in support of equipment qualifications (IQ/OQ/PQ), design verification, continuous improvement projects, validation activities and Gage R&R studies.
- Lead cross-functional teams in the creation and development of risk management documents, Process FMEA and others as required by JenaValve internal procedures.
- Lead cross-functional teams in the generation and implementation of improvement projects.
- Assist in the completion, generation and implementation of the Validation Master Plan and supporting activities.
- Audit the manufacturing line to ensure compliance to governing procedures is being met.
- Execute Internal and External (supplier) audits.
- Maintain applicable equipment, including preventative maintenance and calibration, in line with the relevant SOPs.
- Lead root cause analysis investigations for production related nonconformities and develop and aid in the implementation corrective actions.
- Take on other roles required to support continuous improvement within Quality and manufacturing. Serve as a mentor to more junior Quality Engineers on quality engineering-related activities.
Required Education and Experience:
- Bachelor of Science degree in engineering.
- 4 years medical device Quality/Regulatory experience in a medical device, pharmaceutical or life sciences technology driven company.
- Experience with nonconformances, investigations, root cause analysis, risk analysis and corrective/preventive actions.
- Must be familiar with 21CFR820, ISO 13485, and ISO14971 requirements.
- Can identify work priorities and deploy resources to ensure business needs are met.
- Must be able to work effectively and collaborate within cross-functional teams.
- Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non- technical personnel.
- Must have strong project management and documentation skills.
- Must take initiative and have the ability to conduct hands-on work.
- Must possess the ability to handle multiple tasks with high attention to detail.