Senior Design Quality Engineer

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At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most.

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Position Overview

The Senior Design Quality Engineer will provide quality leadership to various product development teams for a variety of functions.

Based on the scope of the assigned area, activities may include design control for product requirements, risk management, change control, and ensuring compliant product development.

The position will work within defined protocols and procedures and may lead or assist in developing and documenting new procedures and processes.

This role will also be responsible for driving harmonization of the Exact Sciences QMS so that all sites meet the same Quality Standards.

Essential Duties and Responsibilities

Include but are not limited to the following :

• Represent Quality on a variety of projects as assigned.
• Communicate and collaborate with business partners to ensure robust materials, products, processes, and systems and compliance to procedures and specifications.
• Create documentation and records in the Electronic Quality Management System (EQMS).
• Perform risk assessments and provide risk mitigation strategies.
• Implement processes to monitor product and process performance, compliance, and reliability.
• Implement, conduct, and report on process quality programs using statistical data analysis.
• Review and approve documentation related to Exact Sciences products.
• Conduct periodic reviews of Quality System documentation.
• Generate and distribute Quality metrics as assigned.
• Generate, prepare, and issue data for assigned quality plans.
• Conduct internal and / or supplier audits to drive process standardization and continuous improvement as required by assigned role.
• Conduct root cause analysis and corrective and preventive actions.
• Partner with various teams with timely investigation and resolution of issues to minimize / prevent business disruptions.
• Product Development assignments also include :
• Own Risk Management activities throughout the product development process and product lifecycle.
• Serve as lead Quality representative providing authoritative guidance on ISO 13485, QSR and external standards requirements to product development core teams.
• Accountable for Quality oversight of all Design and Development activities on product development core teams.
• Collaborate with product development core team to develop design and development plans, design requirements, design reviews, design V&V documents, risk management documents, and all other design documentation required to support product development.
• Supplier Management assignments also include :
• Support maintenance of the Approved Supplier List (ASL).
• Communicate and collaborate with suppliers and business partners to ensure robust materials, products, processes, and systems and compliance to procedures and specifications.
• Assist with preparation of Quality Agreements.
• Create Supply Base and Supply Base parts in the Electronic Quality Management System (EQMS).
• Design Transfer & Manufacturing Support Assignments also include :
• Lead and assist Operations in the generation, execution, and review of process, test method, and facility qualification / validation and process improvement projects.
• Provide Operations support for Investigations, Out-of-Specifications, Nonconformances, Deviations, and material release.
• Escalate issues when intervention or a change is necessary.
• Excellent oral and written communication skills.
• 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.
• Regular and reliable attendance.
• Ability to collaborate and work effectively in change and exception management.
• Ability to frequently and accurately communicate with employees and supporting functions in person, via the telephone, or by email.
• Ability to work effectively in a fast-paced, dynamic environment with shifting and competing priorities.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability to travel up to 15% of working time away from work location, may include overnight / weekend travel.
• 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.

Minimum Qualifications

• Bachelor’s degree in a Science or technical field; or Associate’s degree in Science or technical field and 2 years of relevant experience as outlined in the essential duties in lieu of a Bachelor’s degree.
• 5+ years of experience in quality principles and practice including experience in assigned area (Design Control, Supplier Management, Risk Management, etc.).
• Product Development assignments require 8+ years of experience in product development in the medical device industry with experience in complex systems including software.
• Design Transfer assignments require 8+ years of experience in process validation principles and practice.
• Manufacturing Support assignments require 8+ years of experience in a manufacturing operation environment.
• Demonstrated ability to successfully work within an CFR 820, ISO 13485, ISO 9001, and / or cGMP structured environment.
• Authorization to work in the United States without sponsorship.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications

• 4+ years of experience in a biotech or manufacturing environment, preferably in a GMP and / or ISO13485 environment.
• Certified Auditor is a plus (ISO 13485).
• Demonstrated experience in support of qualification and monitoring programs.
• Practical experience in FDA and ISO regulated environments.
• Experience with electronic product life cycle (PLM) systems such as Agile.

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Salary Range :

$109,000.00 - $174,000.00

The annual base salary shown is for this position located in US - WI - Madison on a full-time basis. In addition, this position is bonus eligible, and is eligible to receive company stock upon hire as well as annually.

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage.

Learn more about our benefits .

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging.

If you require an accommodation, please contact us here .

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