Sr. Engineer, Quality - Remote

Overview

The Sr. Quality Engineer will provide Quality and Compliance related support for the development, manufacture and distribution of healthcare products in accordance with applicable Quality Management regulations.

In Short

• Provide Quality and Compliance support for healthcare products.
• Exercise independent judgment in engineering methods.
• Coordinate among groups and contribute to company objectives.
• Minimum of Bachelor of Science Degree in relevant engineering field.
• 5 years in Quality Engineering/Quality Assurance role.
• Strong project management skills required.
• Demonstrated knowledge of statistical sampling and analysis.
• Lead Quality issue resolution and risk management activities.
• Ensure compliance with quality regulations and standards.
• Collaborate with supply chain partners to assure product quality.

Requirements

• Bachelor's Degree in Biomedical, Mechanical Engineering, or Engineering Technology.
• Lean/Progressive Manufacturing and Quality disciplines.
• 5 years in Quality Engineering/Quality Assurance for medical devices.
• Lean/Six Sigma certification preferred.
• Excellent organizational, writing, and verbal communication skills.
• Proficient with MS Office Suite, including Visio and Project.
• Experience with statistical analysis software (e.g., Minitab).
• Knowledge of quality system regulations (e.g., ISO 13485).
• Travel Requirements are up to 30%.
• Desirable: ASQ Certified Quality Engineer or Lead auditor certification.

Benefits

• Comprehensive benefits package effective on date of hire.
• Educational assistance available for all employees.
• Matching 401(k) retirement plan.
• Flexible working hours.
• Paid holidays, including floating holidays.
• Employee Stock Purchase Plan.
• Referral incentive program.
• Annual bonus eligibility.
• Paid Time Off and Paid Parental Leave.
• Disability Insurance and Life Insurance options.