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Welcome to SVA’s jobs portal, your one-stop shop for finding the most up to date source of employment opportunities. We have partnered with the National Labor Exchange to provide you this information. You may be looking for part-time employment to supplement your income while you are in school. You might be looking for an internship to add experience to your resume. And you may be completing your training ready to start a new career. This site has all of those types of jobs.

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Job Information

Thermo Fisher Scientific Director, Quality in Austin, Texas

When you join Thermo Fisher Scientific, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions.

As the world leader in serving science and with the largest investment in R&D in the industry, you will be empowered to realize your full potential as part of a fast-growing, global organization that values your passion and unique contributions. Our commitment to you and our 90,000 colleagues is to provide the resources and opportunities you need to make a difference in our world while building a fulfilling career with us.

Position Summary

Genetic Science Division (GSD) is looking for an expert transformational leader to lead the Quality organization at our Austin campuses. This impactful role will develop short and long-term strategies to drive results in our Quality function. The Director of Quality is a leadership position responsible for site compliance to applicable regulations, internal and external audits and certifications, product quality, and building a customer-focused quality culture. This includes optimizing the customer experience through customer feedback, complaint handling, corrective actions and preventive actions, risk management, and delivering products that represent industry-leading standards of product quality.

This position reports directly to the Sr Director of Quality Operations at Genetic Science Division (GSD).

Key Duties and Responsibilities

  • Direct a staff of approximately 45-50 quality professionals.

  • Responsible for ensuring the organizational health of the quality team. This includes proper development programs and succession planning.

  • Drives a culture of quality and ownership across the various Austin site locations.

  • Site Management Representative to the Quality Management System (QMS)

  • Accountable for the continued development and maintenance of compliance to US FDA Quality Systems Regulations, 21CFR820 USDA requirements, and applicable ISO standards

  • Serve as the Person Responsible for Regulatory Compliance for product release from Austin site, accountable for compliance to IVDR and build out of IVDR capability.

  • Collaborate with functions including R&D, Operations & GSS teams and establish post-market surveillance and complaint management capability as the legal manufacturer of CE-IVDR

  • Direct the External (FDA, USDA, Notified Body, Customers) and internal audit Programs for the organization

  • Ensure effective supplier management in partnership with the Procurement organization

  • Introduce and implement the quality processes and tools required to ensure product quality

  • Ensure CAPA, complaint handling, post-market surveillance, process controls, labeling, validation calibration and change management processes are effective and efficient

  • Ensure continuous improvement through the Practical Process Improvement (PPI)

  • Manage a mix of RUO (ISO 13485) and cGMP Quality operations; assure compliance to corporate standards and industry standards

Minimum Requirements/Qualifications:

  • Completion of a university degree of a course of study in –Engineering, Life Sciences, Pharmacy, or related field/engineering degree preferred

  • 6+years of professional experience in quality management systems or in regulatory affairs related to invitro diagnostic medical devices

  • 8+ years of professional quality experience dealing with medical or invitro diagnostic devices; familiarity quality aspects of assay components and chemistries in IVD

  • Experience in auditing and/or implementing ISO 13485, IVDD, FDA MDSAP, IVDR, cGMP

Desired Qualifications:

  • Able to manage in a global matrix organization environment.

  • Ability to handle uncertainty and mitigate risk.

  • Able to think strategically, creatively and rationally.

  • Strong communication (verbal and written) and good interpersonal skills with all levels.

  • Strong planning, negotiation & organizing skills.

  • Ability to travel domestically and internationally – up to 15%

At Thermo Fisher Scientific, each one of our 90,000 outstanding minds has a unique story to tell. Join us and contribute to our focused mission—enabling our customers to make the world healthier, cleaner and safer!

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.