Quality Engineer

Job Description

Target Pay Range: 49-59/hr

* Depending on experience

Innovation starts from the heart. We put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease and critical care. As part of our Quality Engineering team, you will work closely with our R&D and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients lives around the world.

How you will make an impact:

• Perform Quality Engineering activities related to product development and ongoing cleanroom build support

• Ensure NPD processes comply to quality system and applicable regulatory standards.

• Update risk management and design control files. Maintain relevant quality documentation.

• Develop and execute test methods validations and qualification plans.

• Support design verification and facilitate process validation and commercialization activities related to multi-site transfer.

• Work collaboratively with cross-functional teams, including R&D, manufacturing, regulatory, clinical, and marketing.

• Other duties assigned by Leadership.

What you'll need (Required):

• Bachelors degree in engineering or Scientific field & 4+ years' experience
-OR
- Master's Degree or equivalent in Engineering or Scientific field & 3+ years' experience

What else we look for (Preferred):

• Proficient understanding of medical device operations and/or manufacturing processes. Medical Device experience strongly preferred.

• Relevant experience in product development, quality assurance, and/or related fields

• Knowledge and understanding of Engineering and Quality principles, theories, and concepts

• Understanding of ISO 13485

• Experience developing, updating, and maintaining technical content of risk management files

• Basic understanding of statistical techniques. Experience using statistical software (i.e. Minitab) a plus.

• Experience in test method development including validation and/or fixture development

• Solid problem-solving, organizational, analytical, and critical thinking skills

• Good documentation and communication (e.g., written and verbal) skills with keen attention to detail

• Ability to build productive working relationships and interact professionally with all organizational levels

• Ability to manage competing priorities in a fast-paced environment

Equal Opportunity

Employer:

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate.

We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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