Job Description

As a Senior Quality Engineer, you will be part of a cross-functional team that creates high-quality, regulatory compliant, innovative products that delight our customers and improve our world. The Senior Quality Engineer is engaged in all phases of product development (conceptualization, development, verification, commercialization), and will help to develop the skills and provide mentorship of other engineers within the team. You are a technical leader passionate about product development and have design quality experience within regulated industries.

Primary Accountabilities:

• Support development of engineering / product concepts that are innovative, high-quality, cost-appropriate, and satisfy all stakeholder's (customer, manufacturing, material, agency, etc.) needs and requirements through an established area of technical specialty and mentorship of others on the global discipline team.
• Manage or support risk management activities including risk management planning and Risk Analysis ownership activities such as FTA and DFMEA.
• Ensure adherence to defined laws, regulations, standards, guidelines, and specifications primarily in the healthcare and life sciences industry (IEC 60601-1, 21 CFR 820, ISO 13485, ISO 14971, etc.).
• Ensure adherence to Quality Management System (which follow ISO 9001, ISO13485, AS9100, and 21CFR820).
• Demonstrate effective communications (teleconference, email, and in-person) through interaction with customers (internal and external) regarding project technical subject matter.
• Demonstrate skill in the full product realization process, specifically pre-production.
• Demonstrate the ability to work independently in multiple phases for the Product Realization Process, without direction from mentors or functional management.
• Assist project management in the development of proposals to ensure accurate technical, staffing, budgetary, and schedule content.
• Demonstrate desire and skill in coaching and mentoring other quality team members on technical and role-related competencies.
• Drive continuous improvement of QMS processes through CAPA and other improvement initiatives.
• Support the Lean culture and effectively utilizes Lean Sigma concepts and tools to identify and eliminate waste while improving processes.

Required Qualifications

• A Bachelor's degree in Engineering
• Five (5) years of relevant experience
• Compliance in regulated environments, specifically healthcare and life sciences
• Full life cycle product development with a focus on pre-production
• Quality documentation for regulatory submissions

Additional Qualifications

• Experience planning and guiding design verification activities
• Strong decision making, problem solving skills
• Experience working with Safety Agencies (such as Nationally Recognized Testing Laboratories (NRTL))
• Intermediate cybersecurity experience, specifically planning, threat modeling, and risk management
• Experience ensuring product compliance in aerospace industry (AS9100)
• Experience managing product testing (ex. safety, EMC, transportation)
• Experience performing Non-Product Software Validation

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