Quality Assurance Operations Engineer

About us

At Theranica Bio Technologies, we are at the forefront of developing innovative, wearable treatments for migraine and other pain conditions, merging cutting-edge technology with patient-centered care. Our goal is to translate our technological and business knowledge in mobile digital solutions to the field of pain therapeutics.

We offer non-invasive, drug-free, personalized, and affordable wearable therapeutic products for the treatment of pain by integrating the latest neuroscience research with notable technological expertise.

Our collaborative and dynamic work environment fosters creativity and growth, encouraging our team to push the boundaries of medical science. By joining us, you'll be part of a passionate group dedicated to improving lives through pioneering health solutions.

Job Brief

We are looking for an experienced and detail-oriented Quality Engineer to join our Quality Assurance team. The ideal candidate will have a solid background in quality engineering, a strong understanding of production processes, and a commitment to delivering high-quality products. This role requires a blend of technical expertise, analytical skills, and effective communication to ensure that our products meet the highest standards.

Roles and Responsibilities

• Develop, implement, and maintain quality assurance policies, procedures, and standards to ensure compliance with regulatory requirements (e.g., 21 CFR 820, ISO 13485).
• Oversee the execution of quality assurance activities across the product lifecycle, from development through post-market surveillance.
• Ensure that all quality processes comply with relevant medical device regulations and standards.
• Identify, document, and track product defects and non-conformities. Investigate root causes and implement corrective and preventive actions (CAPAs).
• Collaborate with cross-functional teams to resolve quality issues and ensure timely resolution.
• Develop and implement inspection and testing procedures to ensure products meet established quality standards.
• Conduct audits and inspections to assess adherence to quality standards and regulatory requirements.
• Analyze quality metrics and data to identify areas for improvement and implement best practices.
• Conduct verification and validation activities, including hardware and software testing, and document test results.
• Drive continuous improvement initiatives within the quality management system and overall product quality.
• Prepare and present detailed quality reports, including audit findings, test results, and performance metrics.
• Provide training and support to team members and stakeholders on quality standards, procedures, and best practices.
• Act as a quality advocate within the organization, promoting a culture of quality and compliance.

Qualifications & Requirements

Must Have

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Quality Assurance, or a related field.
• Proven experience of a minimum of 3 years as a Quality Assurance Engineer in the medical device industry.
• Experience with quality management systems (QMS) and tools such as risk management (ISO 14971), CAPA, and non-conformance management.
• Strong analytical and problem-solving skills, with a keen attention to detail.
• Excellent communication skills, both written and verbal, with the ability to interact effectively with regulatory bodies, team members, and other stakeholders.
• High-level English skills – writing, reading, and speaking.

Nice to Have

• Proficiency in design control processes, including design verification and validation.
• Knowledge of statistical analysis and quality improvement methodologies (e.g., Six Sigma, Lean).
• Familiarity with electronic quality management systems (eQMS) and documentation tools.

Work environment

Willing to travel as required, 20% traveling.

Physiological Requirements

Color blindness test.