Quality Assurance Engineering Manager jobs in Newton, MA

Associate Director (Human Factors Engineering)

Do you have a passion for science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the place for you!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Summary of the group:

The Human Factors Engineering Group provides human factors (HF) expertise and leads human factors engineering (HFE) work on device development project teams developing drug delivery systems. The Human Factors Engineer may support more senior Human Factors Engineers, and/or directly collaborate with cross functional teams, including device engineering, regulatory, quality, clinical, program management, and marketing, to develop drug device combination products and ensure these products are safe and effective for use.

About the role:

The successful candidate will be a strong voice of user/patient centricity across AstraZeneca. This candidate will be a leader in the human factors engineering group. They will build strong relationships and collaborate with cross-functional leaders in development, regulatory, quality, clinical, commercial, and operations, to guide development of combination products and ensure these products are safe and effective for use.  

Main Duties & Responsibilities:

• Proactive management of human factors engineering work across pipeline projects. Anticipate potential design/regulatory/quality risks, and develop actionable strategies following the latest industry and regulatory best practices and trends.  

• Developing the strategy for and authoring Human Factors sections for health authority interactions and submissions. Interact with health authorities during face to face meetings and written responses.

• Lead human factors development activities for patient-centric device innovations

• Contribute to new product introduction efforts for parenteral combination product launch and on-market support by applying human factors principles and standard methodologies

• Collaborate with external Human Factors consultancies and develop vendor strategy appropriate for the overall parenteral pipeline.

• Engage with AstraZeneca senior leaders in development, quality, regulatory, clinical, commercial and operations with regards to HF strategy, implementation and best practices.

• Lead, mentor and manage a group of HF engineers.

• Be a voice of user-centricity across all product types in AstraZeneca.

• Be engaged with and influence Human Factors best practices externally across industry and with regulators

• Develop and find opportunities for improvement of internal Human Factors practices and associated business processes to ensure consistency, compliance and efficiency with internal business partners and counterparts

Education & Experience Requirements:

Education: Bachelor’s or Master’s Degree in human factors engineering, bioengineering, mechanical engineering, or related field

Experience:

Bachelor’s Degree and 15 years of related experience with at least 7 years of experience in applying human factors engineering to medical device or combination product development -OR- Master’s Degree and 12 years of related experience with at least 7 years of experience in applying human factors engineering to medical device or combination product development. 

Required Skills:

• Advanced knowledge in Human Factors engineering for combination products including a in-depth knowledge of US/EU guidances and standards related to human factors/usability, design controls and risk management. Ability to adapt human factors strategies to the evolving regulatory expectations in the combination product space.

• Experience in health authorities (FDA, EMA, Notified Bodies, and other regulators) submissions and associated interactions

• Experience with GxP responsibilities to provide applicable data and reports for health authority submissions and approvals. Familiar with health authority and quality audits.

• An understanding of the drug/device development process including a balanced perspective on how to integrate Human Factors work into these processes.

• Ability to build relationships with and manage external Human Factors consultancies to execute research activities

• Strong communication, organizational and technical problem-solving skills with an ability to influence internal stakeholders as well as external industry and health authorities

• Ability to lead a team, create a positive work environment and effectively develop staff

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a biopharmaceutical company can be. This means we’re opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey.

When we put unexpected teams in the same room, we spark bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.