Job Description:

Senior Manager, Quality Engineering

Job Locations

US-CA-Redwood City

Summary of Major Responsibilities

The Senior Manager, Quality Engineering will lead the quality engineering team in providing guidance and direct leadership to Exact Sciences for a variety of functions; including, but not limited to, manufacturing and validation activities that support production, supplier programs, risk management, and product development support and implementation. This role will design and implement quality engineering solutions for all tiers of the information technology solution stack from on-premise infrastructure, to cloud based SaaS application platforms. This role will work side by side with software engineering teams to assess quality needs and apply innovative, best of breed software engineering approaches. The Senior Manager, Quality Engineering will work with several cross-functional teams to create and execute a unified quality engineering (QE) strategy, standards, and technologies that are leveraged across the engineering and business partner organizations.

Essential Duties and Responsibilities

Define and implement testing strategies that encompass cloud-based COTS/SaaS application platforms.
• Participate in project design reviews to ensure that application designs adhere to QE guidelines and standards.


• Apply general and QE technical expertise, such as system stack, test automation frameworks, APIs/Web Methods, and RDBMS, and knowledge of QE standards and best practices, such as risk assessment methodology, to develop quality plans that deliver solutions to the business in the most efficient and effective manner.


• Influence and co-define QE's strategic direction, roadmap, technology, and processes.


• Partner with business and technology teams to prioritize roadmaps and requirements while balancing business need with capacity and technology constraints.


• Deliver software products that meet ISO13485 and FDA compliant standards along with supporting documentation.


• Provide technical leadership and guidance to the internal cross-functional project team to ensure that project execution is consistent with the quality plan and SDLC.


• Work closely with internal cross-functional and external teams to influence the complete system architecture and design for systems associated with existing domains and/or conceptual like-for-like technology upgrades, migrations, and replacements to ensure fully testable, functioning, reliable, and performing integrated systems.


• Establish quality program co-definitions and execution for integrated and actionable digital media solutions on a variety of mobile and tablet platforms.


• Resolve most internal and external operational and strategic cross-functional project-related issues, such as scope, resources, timeline, quality, test status, and environments, independently and with project working team; consult with IT senior management, when necessary.


• Create adaptive and Innovative QE architecture, tools, and techniques to include optimization of hybrid off-shore/on-shore resourcing and application of best of breed, risk-based testing methods, levels, and types.


• Develop a strong and broad quality and technology staff that can drive success for both the QE team and broader solution delivery teams.


• Set clear objectives and goals for a team of full-time and on-premise/off-premise contractors utilizing best practice models and metrics to continually assess progress and improve.


• Supervise staff; including, but not limited to, organize and prioritize work, write/conduct performance reviews, train/develop, and manage work performance.


• Communicate goals clearly to employees to ensure understanding and success in achieving them.


• Motivate and inspire employees to do their best work through coaching.


• Maintain morale and support employee engagement initiatives.


• Apply effective communication and presentation skills with the ability to communicate effectively at various degrees of altitude.


• Ability to work successfully in a complex, matrix organization leading through influence and direct authority across intact teams and larger organizations.


• Apply strong technical leadership and people management skills.


• Ability to drive continuous improvement in organizational performance, efficiency, and career development for employees.


• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.


• Support and comply with the company's Quality Management System policies and procedures.


• Maintain regular and reliable attendance.


• Ability to act with an inclusion mindset and model these behaviors for the organization.


• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.


• Ability and means to travel between Redwood City locations.


• Ability to travel 15% of working time away from work location, may include overnight/weekend travel.

Qualifications

Minimum Qualifications

• Bachelor's Degree in Engineering, Science, Biology, Chemistry, or field as outlined in the essential duties; or High School Diploma or General Education Degree (GED) and 4 years of relevant experience as outlined in the essential duties in lieu of Bachelor's Degree.


• 8+ years of experience in engineering or information technology.


• 3+ years of direct leadership experience.


• 2+ years of QE technical leadership experience.


• Demonstrated success working within a CFR 820, ISO 13485, ISO 9001, and/or cGMP structured environment.


• Demonstrated ability with delivering outstanding outcomes for customers, project sponsors, and engineering partners in a customer-driven technology organization.


• Demonstrated strong ability with utilizing agile methodologies to arrive at difficult engineering decisions quickly.


• Advanced proficiency in Microsoft Office programs, such as Word, Excel, PowerPoint, Outlook, Access, OneNote, Publisher, and SharePoint.


• Demonstrated ability to perform the essential duties of the position with or without accommodation.


• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• Experience working in one of the following areas: SFDC, CRM, ERP, LIMS, EMR, Bioinformatics, or clinical data management.


• Experience working in a regulated environment such as SOX, HIPAA, CLIA, GCP, FDA, and/or ISO 13485.


• Enterprise class information technology experience in Custom-COTS Hybrid, Integrated Multi-Channel End-User, and/or Multiple Mobile Platform Delivery.


• Demonstrated understanding of the clinical lab environment.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law. Applicable portions of the Company's affirmative action program are available to any applicant or employee for inspection upon request.