Associate Supplier Quality Engineer

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Position Overview

The Associate Quality Assurance Engineer, Supplier Quality will provide support to the Supplier Quality Engineering team. The position may lead or assist in developing and documenting new procedures for Supplier Quality Engineering. This position will operate independently with periodic supervision.

Essential Duties

Include, but are not limited to, the following:

• Perform Quarterly Supplier Reviews for suppliers on the Approved Supplier List (ASL) with collaboration with Purchasing, Sourcing and SMEs.
• Document supplier communication in the QMS and ensure appropriate completion of tasks prior to closure.
• Assist Supplier Quality Engineers with supplier management tasks as required.
• Assist with data collection for Supplier Business Reviews and Supplier Metrics.
• Participate as a Quality representative on process improvement projects and by interpreting Quality compliance with proposed changes
• Draft Quality Agreements with critical suppliers and manage through system for approvals.
• Review and approve changes to SOPs and Manufacturing Work Instructions (WI) to ensure compliance with relevant regulatory (cGMP, ISO, ICH) regulations.
• Perform other related duties as assigned by management.
• Ability to frequently and accurately communicate with employees in person, via the telephone or by email.
• Proven ability to work effectively with and through multi-functional teams to achieve results.
• Excellent interpersonal skills with the ability to collaborate closely with Operations staff at varying levels to drive compliance and operational excellence.
• 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 work designated schedule.
• Ability to lift up to 40 pounds for approximately 25% of a typical working day.
• 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 to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability and means to travel between Madison locations.
• Ability to travel 5% of working time away from work location, may include overnight/weekend travel.
• Ability to work onsite at least 90% of the time.

Minimum Qualifications

• Bachelor's degree in an engineering or science field with focus on biology and/or chemistry, or related field or an Associate degree with an additional 2 years of experience.
• 2+ years of experience in a manufacturing operation environment.
• 1+ years of experience in Quality principles and practice.
• Knowledge and experience working 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

• 2+ years of experience in a biotech manufacturing environment, preferably in a GMP and/or ISO13485 environment.

Salary Range:

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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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law.

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