Engineer , Design Quality

Quality Engineer

Provide quality support for
*** Consumable development and DHF Remediation. The Quality Engineer will support activities such as CAPA investigations, design projects, and will ensure compliance with
*** quality system requirements and applicable regulations and standards, such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards.

Essential Duties & Responsibilities

• Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc. to assure product quality.
• Assures conformance with regulations of the FDA and other international regulatory agencies.
• Ensure all Quality attributes for design changes are met.
• Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc.
• Ensure that potential product and process risks are evaluated, prioritized, and mitigated to continuously improve product quality.
• Support any potential internal and/or external audits and inspections.
• Effectively interact with cross-functional team members.
• Provide quality support and for on-market product issues. Bring issues to closure and escalating to management for support as necessary.
• Work special projects as assigned

Knowledge & Skills

• Experience in quality engineering, product design or product engineering.
• DHF Remediation
• EU Medical Device Regulation 2017/745 (EU MDR) Quals

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age
• Bachelor's degree in engineering (Electrical, Mechanical, Biomedical) or related field from an accredited college or university is required.
• Minimum of 0 - 2 years of experience in R&D and/or Quality is required.

Work Environment

• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.
• Typically requires travel less than 5% of the time