Senior Quality Engineer

TDA Research•Golden, CO

14d•$95,000 - $140,000

About The Position

TDA Research, Inc. is seeking a Senior Quality Engineer to lead and operate the Quality Management System (QMS) for its medical technologies. Under the direction of a Principal Mechanical Engineer, this role will oversee QMS certification, daily operation, and continuous improvement, ensuring end-to-end product quality. The position combines hands-on quality engineering with strategic quality leadership and works closely with internal quality consultants, engineering, operations, and company leadership to build scalable quality systems and embed quality into product development, supplier management, production, and risk mitigation. The role includes developing and maintaining quality documentation and workflows; managing audits, CAPA activities, and document control; supporting regulatory compliance with standards including ISO 13485 and ISO 14971; training personnel on QMS practices; supporting verification and validation; and ensuring projects follow appropriate quality procedures. The position is suited to someone who can contribute in a fast-moving environment and help shape the company’s quality culture as it grows. The listed annual salary range is $95,000–$140,000, with potential for a performance bonus. TDA offers a comprehensive benefits package to regular employees working 30 or more hours per week. No sponsorship is offered.

Requirements

Bachelor’s degree in engineering, quality, or a related field.
5–8+ years of quality engineering experience in a manufacturing environment, preferably at a small company, or experience transitioning a new product from development through regulatory approval and product launch.
Strong leadership, technical writing, audit execution, system maintenance, and process validation skills.
Early-stage individual contributor.
Ability to deliver well-organized training to multidisciplinary teams.
Hands-on experience maintaining a QMS.
Working knowledge of U.S. 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 the FDA, registrars, or notified bodies.
Ability to thrive in fast-paced, ambiguous startup environments.

Nice To Haves

Experience with quality control across 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 such as medical devices, aerospace, automotive, or biotech.
Working knowledge of international medical device regulations, including EU MDR.
Background in Lean/Six Sigma methodologies.
Ability to balance long-term and short-term priorities, detail-oriented work, and big-picture thinking.
Basic regulatory knowledge to assist new product development.

Responsibilities

Serve as the Quality System Management Representative and deploy and maintain a right-sized QMS aligned with ISO 13485, ISO 14971, and other relevant standards.
Optimize SOPs and create work instructions, templates, and quality workflows that support rapid iteration while maintaining compliance.
Plan and conduct internal audits, track findings, and drive corrective and preventive actions (CAPAs).
Manage document and record control systems to ensure traceability and revision integrity, and maintain company- and project-specific quality documentation for ISO 13485 compliance.
Lead risk assessments, including FMEA and hazard analysis, and collaborate with product engineers to integrate risk controls into product and process design.
Qualify suppliers, maintain supplier records, monitor supplier performance, and execute corrective actions as needed.
Lead and collaborate with engineers on process verification and support design verification to ensure conformance with quality standards.
Develop and deliver quality training to promote organization-wide adoption of and adherence to QMS practices.
Define quality KPIs, monitor performance, and report quality trends to leadership.
Support regulatory submissions and lead certification activities.
Promote continuous improvement through Lean, Six Sigma, and data-driven problem solving.
Maintain professional and technical knowledge by attending educational workshops, reviewing professional publications on QMS and FDA regulations, and participating in professional societies; related costs are paid by TDA.

Benefits

Medical, dental, vision, accident, and critical illness insurance.
Disability and life coverage.
Health savings accounts.
Flexible spending and dependent care accounts.
401(k) savings plan with employer match.
Employee Assistance Program (EAP).
Generous one-use PTO policy.
Bereavement and jury duty coverage.
Applicable federal and state leave programs, including FMLA and CO FAMLI.
Potential for a performance bonus.
Professional society participation costs related to professional development are paid by TDA.