Senior Quality Engineer
Reporting to the Sr. Manager/Director of Product Quality, the Sr. Quality Engineer will be an integral part of the QARA team with the primary responsibilities that include:
- Planning & driving various product quality improvement activities and/or projects,
- Supporting supplier qualification and development activities,
- Reviewing Device History Records prior to shipment,
- Providing QA/QS support and guidance to functional groups including but not limited to Manufacturing, Engineering, R&D, Purchasing, Customer Service, Product Support, etc., and
- Playing a key role in the New Product Development/Introduction process.
- Use key product/process metrics to evaluate process effectiveness, identify improvement opportunities/best practices, and drive continuous quality improvement activities.
- Lead cross-functional teams in the execution and reporting of continuous improvement projects with a focus on overall warranty/defect reduction.
- Partner with Supplier Quality Engineering/Manufacturing Engineering/QA on supplier qualification/development activities.
- Partner with Supplier Quality Engineering/Manufacturing Engineering/QA on planning and implementation of various Dock-to-Stock initiatives.
- Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
- Work closely with production line and ensure all necessary controls are fully implemented to be compliant with ISO13485/9001 and FDA QSR requirements.
- Review assigned Device History Records (DHR’s) and associated documents prior to shipment to ensure that all documents and specifications are met.
- Provide support to Operations including the review and approval of manufacturing work instructions, deviation requests, and nonconforming material reports, and Engineering Change Orders.
- Conduct internal and supplier audits (as assigned).
- Serve as a core team member on NPD projects to ensure compliance with design controls per ISO 9001/13485, and FDA QSR.
- Participate in Design Reviews and identify possible improvements based on relevant risk analysis, past manufacturing/warranty experience, and Marketing/Customers’ specifications/requirements for products.
- Participate in internal PPI (Process Kaizen) activities (as assigned).
- Bachelor’s degree in EE, ME, Chemistry, or other relevant fields required.
- A minimum of 10 years of QA experience.
- Hands-on experience working with various Mass Spectrometry instruments is preferred.
- Ideal candidate must possess considerable hands-on experience in Medical Device manufacturing with strong working knowledge of FDA QSR, IVDD and ISO 13485/9001.
- Certified ASQ CQE/CQA preferred.
- Experience with Phase Gate Review Process.
- Extensive experience working with Contract Manufacturers is a plus
- Proficient in use of statistical analysis and methods.
- Must be team oriented and have excellent interpersonal skills.
- Must have excellent written and verbal communication skills with ability to clearly articulate requirements.
- Must be practical and flexible to effectively work with individuals from multiple functional groups.
This position has not been approved for Relocation Assistance.