What are the responsibilities and job description for the Senior Quality Engineer, IVD Product Software Validation position at Thrive, an Exact Sciences Company?
Summary of Major Responsibilities
This Senior Quality Engineer position will be filled by a person with experience in software validation, automated equipment validation, and process validation in an FDA Part 820 regulated environment. This person will excel at working collaboratively to ensure that projects are completed within timelines and in an FDA compliant manner. Being able to switch gears quickly as the need arises and juggle diverse responsibilities is essential.
Essential Duties and Responsibilities
- Serve as the Quality lead on projects relating to Medical Device software development and validation.
- Work with the Laboratory Operations team to review Quality documents for regulatory compliance with FDA, CLIA and CAP.
- Demonstrate strong proficiency in the application of the Corrective and Preventive Action system and root cause tools.
- Participate in the completion of equipment and process validations in conjunction with Lab Ops personnel. Provide review and approval of validation protocols and reports.
- Mentor/coach all teams with regards to quality. Participate in providing organizational training for Quality.
- Participate in the proper management of deviations, nonconforming product, complaint handling and change control.
- Responsible for maintaining, updating and versioning of policies and protocols.
- Ensure that record keeping under FDA/GLP requirements are attributable, legible, contemporaneous, original and above all, accurate.
- Provide quality oversight of equipment preventive maintenance and calibration activities.
- 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 designated schedule.
- Ability to work on a mobile device, tablet, or in front of a computer screen.
- Ability to work on a computer and phone simultaneously.
- Ability to comply with any applicable personal protective equipment requirements.
- Ability to use various types of laboratory equipment; including microscopes, microtomes, blades, strainers, and pipettes for extended periods of time.
- May perform repetitious actions using lab tools.
- May be exposed to hazardous materials, tissue specimens, and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.
- Ability to travel 10% of working time away from work location, may include overnight/weekend travel.
Qualifications
Minimum Qualifications
- Bachelor’s Degree in relevant scientific field from an accredited college or university as outlined in the essential duties.
- 5 years of direct quality assurance experience.
- Demonstrated experience with equipment and process validations, as well as laboratory operations, quality control and/or engineering.
- Demonstrated knowledge of GMP regulations and guidance documents.
- Ability to deliver results on schedule in a fast-paced, dynamic environment.
- Strong experience in evolving and scaling Quality System processes as a company grows.
- Strong experience in performing Corrective and Preventative Actions (CAPA), change control, and deviation (nonconformance) processes, as well as performing and facilitating root cause analysis investigations.
- Advanced knowledge of HIPAA and history of working with confidential patient information.
- Demonstrated interpersonal skills in working with teams and problem solving.
- 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
- Demonstrated experience in the diagnostics industry.
- Strong Quality Assurance experience in working within companies having CLIA and CAP certified laboratories.
EEO Disclosure
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.