TDA Research, Inc., is located outside Denver, Colorado with research offices in Golden. The company has a staff of over 100 employees, which consists of mainly engineers and scientists who develop cutting edge chemical processes, materials, and devices for customers in the defense, aerospace, energy, medical, and chemical industries. We rely on a high level of technical competence and efficiency within our team and look for motivated, talented, and skilled innovators to join us in developing advanced solutions.Under the direction of a Principal Mechanical Engineer the Senior Quality Engineer will serve as the driving force behind the TDA’s Quality Management System, leading its certification process, daily operation and continuous improvement for its medical technologies, ensuring end-to-end product quality. This role blends hands-on quality engineering with strategic quality leadership. Examples include implementing quality documentation, managing internal and external audits, overseeing CAPA activities, ensuring regulatory compliance with relevant standards such as ISO 13485 and ISO 14971, training personnel how to use the quality system, aiding in V&V activities, and ensuring projects follow proper quality procedures. Working closely with internal quality consultants, engineering, operations, and leadership, the Senior Quality Engineer will embed quality into product development, supplier management, production and risk mitigation, while building scalable systems that support rapid growth. This position is ideal for someone who thrives in a fastmoving environment and enjoys shaping a company’s quality culture from the ground up.
Roles & Responsibilities:- QMS Implementation and Management — Serve as the Quality System Management Representative; deploy and maintain a right‑sized QMS aligned with ISO 13485, ISO 14971 and other relevant regulatory standards.
- Process Development — Optimize SOPs and create work instructions, templates, and quality workflows that support rapid iteration without sacrificing compliance.
- Internal Audits — Lead, plan and conduct internal audits; track findings; and drive corrective and preventive actions (CAPAs).
- Document Control — Manage and operate document and record control systems to ensure traceability and revision integrity. Maintain company and project specific quality documentation to ensure ISO 13485 compliance.
- Risk Management — Lead risk assessments (FMEA, hazard analysis) and collaborate with product engineers to integrate risk controls into product and process design.
- Supplier Quality — Qualify suppliers, maintain supplier records, monitor supplier performance and execute corrective actions as necessary.
- Product Verification and Validation – Lead and collaborate with engineers to execute process verification and ensure conformance to quality standards. Collaborate with engineers to support design verification.
- Training Programs — Develop and deliver quality training to ensure organization-wide adoption of and adherence to QMS practices.
- Quality Metrics — Define KPIs, monitor performance, and report quality trends to leadership.
- Regulatory Compliance — Support regulatory submissions and lead certification activities.
- Continuous Improvement — Champion a culture of quality through Lean, Six Sigma, and data-driven problem solving.
- Company and Professional Development – Remain up to date on professional and technical knowledge by attending educational workshops, reviewing professional publications on QMS and FDA regulations, and participating in professional societies (related costs paid by TDA).
Required Knowledge, Skills and Abilities:- Bachelor’s degree in engineering, quality, or related field.
- 5–8+ years of experience in quality engineering in a manufacturing environment, preferably in a small-company environment, or involved in transitioning a new product from development to regulatory approval and product launch.
- Strong leadership, technical writing, audit execution, system maintenance, and process validation skills.
- Early-stage individual contributor.
- Capable of delivering well organized training to multi-disciplined teams.
- Hands-on experience maintaining a QMS.
- Working knowledge of US medical device regulations, including ISO 13485 and CFR 820.
- Strong analytical and problem-solving skills.
- Excellent communication and cross-functional collaboration abilities.
- Excellent organizational and project management skills.
- Experience with CAPA, root cause analysis, and risk management tools.
- Familiarity with digital QMS platforms and document control systems.
- Experience leading audits or working with FDA, registrars, notified bodies.
- Ability to thrive in fast-paced, ambiguous startup environments.
Preferred Knowledge, Skills and Abilities:- Experience with quality control in a variety of medical technologies, including medical devices and pharmaceuticals.
- Working knowledge of ISO 9001.
- ASQ CMQ/OE, CQE, CQA, or similar certification.
- Hands-on experience implementing a QMS.
- Experience with paper-based quality systems.
- Experience in regulated industries (medical devices, aerospace, automotive, biotech).
- Working knowledge of international medical device regulations, including EU MDR.
- Background in Lean/Six Sigma methodologies.
- Ability to balance long term, short term, detail-oriented and big picture thinking.
- Basic regulatory knowledge to assist new product development.
Salary range per year: $95,000 – $140,000 with the complete benefits package offered. This position includes the potential for a performance bonus. No sponsorship offered.This range is based on a variety of factors including, but not limited to: local market conditions, internal equity, candidate skills, education, and experience.TDA offers a comprehensive benefits package for regular employees working 30+ hours per week. Benefits include: Medical, dental, vision, accident, and critical illness insurance; disability & life coverage; health savings accounts; flexible spending and dependent care accounts; a 401(k) savings plan with employer match; EAP. Our leave program includes a generous one-use PTO policy, bereavement and jury duty coverage as well as the applicable federal and state leave programs (FMLA and CO FAMLI).TDA Research, Inc. is an Equal Opportunity Employer and does not discriminate based on race, color, religion, national origin, sex, sexual orientation, gender identity, age, protected veteran status or individuals with disabilities.If you would like to request assistance with the application or to request a reasonable accommodation, please contact
hr@tda.com
or call 303-422-7819 and request to speak with HR to request an accommodation. The application window closes when the position is filled or unposted.
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