Part-Time Quality Engineer / Quality Manager

Location: St. Paul, MN

Employment Type: Part-time

Will Report To: Head of R&D / VP of Operations

Industry: Medical Devices / Wearable Neurotechnology

We are seeking an experienced Quality Engineer / Quality Manager to lead the development and implementation of our quality management system (QMS) and associated documentation. The ideal candidate will have strong medical device quality experience, a thorough understanding of regulatory requirements (ISO 13485, FDA QSR), and expertise in establishing robust quality processes and documentation frameworks. This role will be integral to ensuring product quality, compliance, and readiness for regulatory submissions. We expect this position to begin as a part-time role that may grow into a full-time position.

Key Responsibilities

Quality System Development & Management

  • Establish, develop, and maintain a compliant Quality Management System (QMS) tailored for medical wearable electronics (ISO 13485, FDA 21 CFR Part 820).

  • Author and manage quality documentation, including SOPs, work instructions, quality plans, and system procedures.

  • Collaborate with cross-functional teams (Engineering, Regulatory, Operations, Clinical) to integrate quality practices into product development lifecycles.

Documentation & Record Control

  • Lead creation and revision control of all quality documentation and artifacts.

  • Implement a document control system with clear versioning, approvals, and traceability.

  • Ensure documentation meets regulatory standards and internal quality benchmarks.

Risk Management

  • Drive risk management activities (ISO 14971), including risk analysis, risk evaluation, mitigation planning, and reporting.

  • Facilitate risk workshops with product and clinical teams.

Design Control & Verification/Validation Support

  • Support design control processes, including design inputs/outputs, verification, and validation documentation.

  • Help translate required standards into product requirements.

  • Ensure traceability from requirements through development and testing.

Training & Compliance

  • Develop and deliver quality training materials for internal teams.

  • Monitor compliance with quality procedures and recommend corrective actions when needed.

CAPA & Continuous Improvement

  • Lead Corrective and Preventive Action (CAPA) processes.

  • Drive continuous improvement initiatives to enhance product quality and process efficiency.

Audit & Regulatory Support

  • Prepare for internal and external audits (supplier, regulatory).

  • Support regulatory submission documentation and responses.

What We Offer

  • Flexible, part-time schedule.

  • Opportunity to shape the quality foundation of a breakthrough neurotechnology product.

  • Collaborative, mission-driven team environment.

  • Competitive compensation based on experience

Required Qualifications

  • Bachelor’s degree in Engineering, Quality, Life Sciences, or related field (Master’s preferred).

  • 5+ years of quality experience in electro-mechanical medical devices, preferably with wearable electronics or physiological signal acquisition systems.

  • Demonstrated experience establishing quality systems from the ground up.

  • Thorough knowledge of ISO 13485, FDA Quality System Regulation (21 CFR Part 820), ISO 14971, and design controls.

  • Strong technical writing skills with a proven track record of producing high-quality documentation.

  • High technical acumen and ability to translate standards into product requirements and identification of gaps and solutions.

  • Ability to help perform verification testing requirements.

  • Experience with risk management, CAPA, change control, and document control systems.

  • Excellent organizational skills and attention to detail.

  • Strong interpersonal and communication skills; ability to work collaboratively with technical teams.

  • Experience with quality tools (e.g., Jira, Greenlight Guru, Master Control, or similar).

Preferred Qualifications

  • Prior experience with electro-mechanical systems.  Familiarity with wearables a plus.

  • Experience supporting regulatory submissions (510(k), CE Mark, UL, etc.).

  • Training or certification in quality a plus (e.g., ASQ CQA, CQE, CQM).

Apply now

What success
looks like

Turn complexity into clarity. Creating a quality foundation that enables faster development without compromising compliance.

The brain is the next frontier in human progress. Cogwear is a brain technology company that promotes human health, peace, and performance by making neurodata more accessible.

The company provides wearable, AI-powered technology for customized healthcare and consumer products, research, and other applications that require high-fidelity, on-demand neurodata outside of a clinical setting. 

Cogwear offers a technology platform that brings together a headband, app, and algorithms to directly and accurately measure brain signals, anywhere, any time – turning data into insights that help people and enterprises reach greater potential than ever before. 

Cogwear’s commercial partnerships make it a pioneer in neuro-based products across a range of areas from athletic safety and CTE screening to advertising optimization and customer experience. The company is pursuing FDA clearance and continues to develop its technology to help tackle pressing health issues, including Alzheimer's Disease, pediatric epilepsy, and mental healthcare.