Associate Quality Assurance Engineer
7 days ago
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. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you're working to help others.
Position Overview
The Associate Quality Assurance Engineer will provide support to Operations for a variety of functions such as material receipt, production, process validation, facility qualification, and test method validation to determine the acceptability of material and the process in which it was manufactured. The position may lead or assist in developing and documenting new procedures for Operations and Quality Engineering. The position will also serve as a Subject Matter Expert for the Operations group to support day-to-day activities through investigation management and evaluating material for release to distribution. This position will operate independently with periodic supervision.
Essential Duties
Include, but are not limited to, the following:
- Participate as a Quality representative on process improvement projects and by interpreting Quality compliance with proposed changes.
- Partner with and provide support to Operations personnel in the completion of production documents, executed test methods to evaluate material prior to releasing for commercial distribution.
- Determine process risks and evaluate mitigations.
- Review executed protocols to determine process validation, test method validations, and equipment qualifications/validations were completed appropriately and ensure deficiencies are corrected prior to using the for commercial production.
- Review equipment calibration records.
- Review and approve changes to SOPs and Manufacturing Work Instructions (WI) to ensure compliance with relevant regulatory (cGMP, ISO, ICH) regulations.
- Provide Operations support for Nonconformance Reports and Deviations and approve disposition of material.
- Actively audits production and support areas to ensure compliance with internal SOPs and 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.
- 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.
- Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis. We are unable to sponsor or take over sponsorship of employment visas at this time.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
- 2+ years of experience in a biotech manufacturing environment, preferably in a GMP and/or ISO13485 environment.
Salary Range:
$62,000.00 - $102,000.00
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.
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.
Not ready to apply? Join our Talent Community to stay updated on the latest news and opportunities at Exact Sciences.
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.
To view the Right to Work, E-Verify Employer, and Pay Transparency notices and Federal, Federal Contractor, and State employment law posters, visit our compliance hub. The documents summarize important details of the law and provide key points that you have a right to know.
-
Computer Systems Quality Assurance
7 days ago
Madison, WI, United States Katalyst HealthCares & Life Sciences Full timeComputer Systems Quality Assurance Specialist We are seeking an experienced Computer Systems Quality Assurance (CSQA) Specialist to support the expansion of our clients ERP systems and associated applications across new and existing manufacturing sites. The CSQA will provide quality oversight to ensure all systems are developed, validated, and maintained in...
-
Systems/IT Quality Assurance Lead, FAA BNATCS
2 weeks ago
Madison, WI, United States Parsons Company Full timeSystems/It Quality Assurance Lead In a world of possibilities, pursue one with endless opportunities. Imagine Next! At Parsons, you can imagine a career where you thrive, work with exceptional people, and be yourself. Guided by our leadership vision of valuing people, embracing agility, and fostering growth, we cultivate an innovative culture that empowers...
-
Madison, WI, United States Parsons Company Full timeSystems/It Quality Assurance Lead In a world of possibilities, pursue one with endless opportunities. Imagine Next! At Parsons, you can imagine a career where you thrive, work with exceptional people, and be yourself. Guided by our leadership vision of valuing people, embracing agility, and fostering growth, we cultivate an innovative culture that empowers...
-
Madison, WI, United States Parsons Company Full timeSystems/It Quality Assurance Lead In a world of possibilities, pursue one with endless opportunities. Imagine Next! At Parsons, you can imagine a career where you thrive, work with exceptional people, and be yourself. Guided by our leadership vision of valuing people, embracing agility, and fostering growth, we cultivate an innovative culture that empowers...
-
Associate QA Engineer: Process
1 week ago
Madison, WI, United States Exact Sciences Full timeA leading healthcare company in Madison, WI, is seeking an Associate Quality Assurance Engineer to support manufacturing and quality compliance. The role involves reviewing production documents, evaluating tests, and ensuring adherence to regulatory standards. Ideal candidates hold a degree in a science or engineering field and have experience in...
-
Associate QA Engineer: Process
4 days ago
Madison, WI, United States Exact Sciences Full timeA leading healthcare company in Madison, WI, is seeking an Associate Quality Assurance Engineer to support manufacturing and quality compliance. The role involves reviewing production documents, evaluating tests, and ensuring adherence to regulatory standards. Ideal candidates hold a degree in a science or engineering field and have experience in...
-
Associate QA Engineer: Process
7 days ago
Madison, WI, United States Exact Sciences Full timeA leading healthcare company in Madison, WI, is seeking an Associate Quality Assurance Engineer to support manufacturing and quality compliance. The role involves reviewing production documents, evaluating tests, and ensuring adherence to regulatory standards. Ideal candidates hold a degree in a science or engineering field and have experience in...
-
Quality Engineer II
1 day ago
Madison, WI, United States Sub-Zero, Wolf, and Cove Scottsdale Full timeSub-Zero, Wolf and Cove are the leading manufacturers of luxury kitchen appliances and a longstanding, family-owned company in the Madison, WI area. Icons of design and paragons of performance and quality, Sub-Zero, Wolf, and Cove are the refrigeration, cooking, and dishwashing specialists found in worlds most luxurious homes. We look for team members who...
-
Quality Engineer II
5 days ago
Madison, WI, United States Sub-Zero, Wolf, and Cove Scottsdale Full timeSub-Zero, Wolf and Cove are the leading manufacturers of luxury kitchen appliances and a longstanding, family-owned company in the Madison, WI area. Icons of design and paragons of performance and quality, Sub-Zero, Wolf, and Cove are the refrigeration, cooking, and dishwashing specialists found in worlds most luxurious homes. We look for team members who...
-
Quality Assurance Analyst-IV
4 days ago
Madison, WI, United States Concord IT Systems Full timeThe Quality Assurance Analyst IV will provide technical assistance and consultation to the Department of Children and Families (DCF) child welfare application, Wisconsin's Statewide Automated Child Welfare Information System (eWiSACWIS). This position supports the overall testing of eWiSACWIS. This position works with the vendor to define and develop...
