Quality Engineer 3 - Endoluminal Systems

Description

This role independently owns quality projects, investigations, inspections and improvement work for the Endoluminal product platform.

Work covers design, manufacturing and service of one selected product or subsystem.

Responsibilities

• Lead product, process and complaint investigations on your own across the Endoluminal product family.
• Act as the escalation owner for product quality risks rated low to medium impact.
• Check test records and reports for completeness and accuracy.
• Drive or take part in CAPAs and systemic process nonconformances.
• Help update and revise QMS documentation.
• Lead risk assessments and process reviews.
• Analyze defect trends, present the data, and report to peers on a set schedule.
• Make sure work meets company and regulatory standards, including GMP, ISO and FDA.
• Serve as a full member of a project core team and contribute to its success.
• Share findings and recommendations with stakeholders.
• Run continuous improvement projects at business unit, organization or team scope.
• Own quality outcomes for a product or defined subsystem.
• Be the reliable quality engineering partner for the cross-functional product team.
• Mentor or coach junior QEs on tools, processes and investigations.
• Lead small initiatives.

Requirements

• Have at least 5 years of experience in QE or QA, plus a bachelor's degree in engineering or a related discipline, or an equivalent mix of education and experience.
• Hold a solid grasp of quality principles and methods.
• Bring solid skills in analyzing and interpreting data.
• Resolve quality issues independently.
• Communicate and present clearly, and collaborate well in teams.
• Keep up with changing standards, tools and technologies.
• Travel less than 10%.
• Expect frequent computer and inspection work.
• Lift occasionally, under 25 lbs, and wear PPE in production or regulated areas.

Conditions

The company or its customers may require current proof of vaccination against certain diseases, including COVID-19; requirements can vary by role.

Some roles may be subject to U.S. export controls, which can affect nationals of countries under embargo or sanctions (15 CFR §743.13(b)).

An export license from the U.S. Government can take 3 to 6+ months, and a Technology Control Plan (TCP) typically adds 2 weeks to hiring.

For export-controlled roles, final offers depend on an approved export license and/or an executed TCP before the start date; these may or may not be flexible and must not unreasonably delay hiring. Candidates will be told of any steps required.

Qualified applicants with arrest and conviction records will be considered under applicable fair chance laws.

Preference goes to qualified candidates who do not live, or plan to live, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina or Tennessee.

The role may be filled at a different job level based on business need or the selected candidate's experience, knowledge and skills.

Pay depends mainly on the job level the role is filled at and the candidate's qualifications, within legal limits.