Remote Quality Engineer Medical Device Jobs in Wisconsin

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters' innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters' passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide. We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

Summary:

The Senior Clinical Research Associate (Sr. CRA) is an experienced clinical operations professional responsible for managing site monitoring and relationship activities across multiple clinical studies. This role serves as a key resource to study teams, ensuring high-quality study execution, adherence to Good Clinical Practice (GCP), regulatory requirements, and company standards. The Sr. CRA provides guidance to less experienced CRAs, supports investigator sites, proactively identifies and resolves operational issues, and contributes to the successful delivery of clinical study objectives.

The Sr. CRA will practice excellent written and verbal communication skills, including medical terminology. In this role the candidate will display strong presentation, organizational, timemanagement, and prioritization skills. Being technically savvy with the ability to leverage technology to drive efficiency and performance while working independently with minimal supervision in a fastpaced environment will be key.

Responsibilities:

Study & Site Management

• Serve as CRA for assigned complex clinical studies, providing expert oversight of site selection, initiation, monitoring, and closeout activities (onsite, virtual, remote).

• Actively participate in site feasibility assessments and site selection processes.

• Ensure study conduct is executed according to the clinical protocol, regulatory requirements (GCP, FDA, ISO), IRB/EC requirements, and company SOPs.

• Prioritize patient safety, ensuring informed consent and study procedures are performed accurately and ethically.

• Review and report AEs/SAEs and protocol deviations in accordance with regulatory and company requirements.

• Maintain complete, accurate, and auditready regulatory documentation and TMFs in accordance with ALCOA principles.

• Monitor site inventory of investigational products and study supplies.

• Proactively identify, communicate, and manage study risks and issues to ensure operational continuity and compliance.

Monitoring & Documentation

• Author, review, and approve Monitoring Plans, study source documents, monitoring tools, and sitefacing training materials.

• Perform SDR/SDV per monitoring plans and document monitoring activities through timely, highquality trip reports.

• Ensure compliance with company travel and expense policies.

Leadership & Mentorship

• Provide mentoring, training, and functional oversight of CRAs, including contingent (contract) CRAs.

• Lead or review functional job aids and training materials.

• Present confidently and contribute to extended functional and study team meetings, providing clear updates on site status, risks, and issues.

Systems & Collaboration

• Utilize and maintain accurate study data in clinical systems, including Veeva Vault CTMS and CDMS.

• Work crossfunctionally with internal teams and CROs to ensure highquality study execution and oversight.

• Build and maintain effective working relationships with investigator sites and internal stakeholders.

Minimum Qualifications

• Bachelor's degree or higher in a healthcare or sciencerelated field. (Alternate education levels may be considered based on experience and business need)

• 3 years of fieldbased CRA experience in the medical device and/or pharmaceutical industry.

• Strong understanding of clinical trial operations, monitoring practices, investigational product management, and data management.

• Thorough knowledge of domestic and international clinical research regulations, including ICH GCP, FDA CFR, ISO, and HIPAA.

Preferred Knowledge & Skills

• Experience with IVD and/or POC studies.

• Laboratory experience in molecular biology, microbiology, or blood culture.

• Proficiency with Veeva Vault CTMS and CDMS

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

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Primary Work LocationUSA MD - Sparks - 7 Loveton CircleAdditional LocationsWork ShiftNA (United States of America)

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

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