Senior Quality Engineer
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Overview
Schedule
Full-time
Education
Engineering (PE)
Career level
Senior-level
Remote
On-site
Compensation
$95,000-$140,000/year
Benefits
Health Insurance
Dental Insurance
Vision Insurance
Job Description
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).
- 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.
- 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.
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FAQs About Senior Quality Engineer Jobs at TDA Research
What is the work location for this position at TDA Research?
This job at TDA Research is located in Golden, CO, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at TDA Research?
Candidates can expect a pay range of $95,000 and $140,000 per year.
What employment applies to this position at TDA Research?
TDA Research lists this role as a Full-time position.
What experience level is required for this role at TDA Research?
TDA Research is looking for a candidate with "Senior-level" experience level.
What education level is required for this job?
The education requirement for this position is Engineering (PE). Candidates with relevant qualifications or equivalent experience may also be considered.
What benefits are offered by TDA Research for this role?
TDA Research offers following benefits: Health Insurance, Dental Insurance, Vision Insurance, Disability Insurance, Life Insurance, Family/Dependent Health, Paid Vacation, Parental and Family Leave, 401k Matching/Retirement Savings, and Health & Wellness Programs for this position. Actual benefits may vary depending on the employer's policies and employment terms.
What is the process to apply for this position at TDA Research?
You can apply for this role at TDA Research either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.