QMS Engineer

St Louis, MO
Full Time
IT
Experienced

For more than 20 years, BioTAB Healthcare, LLC has supported patients with lymphatic, wound, and circulatory disorders through proven treatment solutions. Headquartered in Missouri, we provide pneumatic compression devices and personalized service to help improve patient outcomes and quality of life. As a family-owned company, we take pride in delivering expert care with a personal touch service.

The QMS Engineer for BioTAB Healthcare will develop, implement, and maintain our QMS program to ensure products and services meet or exceed expectations under FDA 21 CFR Part 820, FDA QMSR, ISO 13485:2016, EU MDR 2017/745, and MDSAP. This role will be a key driver for policy implementation strategies, Process Improvement and training. This role will work with the Leadership Team to ensure compliance with relevant regulations and standards, including oversees vendors and processes. 

The QMS Engineer will carry out duties by adhering to the highest standards of ethical and moral conduct while acting in the best interest of BioTAB Healthcare’s growth and maintenance of our ISO standards.  Reporting to CIO, the daily workload will include management of both people and processes, with an emphasis on process execution and quality control.

Key Responsibilities

Compliance:
Ensuring compliance with relevant ISO regulations, standards, and internal policies. Prepares all departments in the organization & various vendors for audit and serves the company’s representative during audit. 

  1. Performing internal and supporting external audits to ensure compliance and identify areas for improvement. 
  2. Overseeing the governance of QMS documentation, including quality manuals, SOPs, procedures, and records. 
  3. Identifying areas for improvement and ensuring corrective and preventive actions are implemented effectively. 
  4. Oversee the establishment, implementation, and maintenance of the QMS in accordance with Lead internal audits, supplier audits, and support third-party and regulatory inspections.
  5. Develop programs and provide guidance on R&D, Regulatory, Manufacturing, and Supply Chain to support product development, design controls, and production quality.
  6. Monitoring and reporting on key performance indicators related to the QMS. 

Risk Management: Implementing risk-based approaches to quality management, identifying and mitigating potential risks. 

Records Retention: Manage and review quality system records, including CAPA, nonconformance, complaints, change control, and risk management files. Maintain procedures for document control, training, supplier management, labeling, and post-market surveillance.

Communication Skills: Excellent communication and interpersonal skills to effectively collaborate with and with various stakeholders. Ability to influence and collaborate across functions and leadership levels. Managing and mentoring teams, providing guidance and support to ensure quality objectives are met. 

Analytical Skills: Investigating quality issues and implementing corrective and preventive actions. Providing technical support to resolve quality-related problems.

Technical Skills: Proficiency in quality systems software (e.g., Arena, MasterControl, Greenlight Guru). Strong understanding of quality management principles, including statistical process control (SPC) and root cause analysis. 

Essential Skills
Problem-solving skills: Strong analytical and problem-solving skills, with the ability to identify root causes and implement effective solutions. 
Attention to detail: To ensure accuracy in patient records and insurance information. 
Excellent organizational and time management skills: To manage a high volume of work and ensure timely processing of information. 

Experience

  • Bachelor’s degree in Engineering, Life Sciences, or related field
  • Minimum 5–8 years of experience in quality assurance within the medical device industry.
  • In-depth knowledge of ISO 13485, FDA QSR (21 CFR Part 820), FDA QMSR and EU MDR.
  • Strong knowledge of risk management (ISO 14971), CAPA, and audit procedures.
  • Familiarity with software as a medical device (SaMD) or combination products.

Preferred

  • Master’s or CQE/CQA
  • Experience with Class II or III medical devices.
  • Knowledge of global regulatory requirements (e.g., MDSAP, Health Canada, TGA).
The QMS Engineer career path may include promotion to a Leadership team role and may supervise direct reports in the future. This role is eligible for a bonus and incentive program based on company metrics and individual achievement. BioTAB Healthcare benefits include 401k with company match, healthcare, vision, dental, life insurance and short term disability.
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