The Role
We are seeking a contract consultant in the role of QA Analyst II to expand our ability to honor every donor organ by transforming the future of medicine together. The Quality Assurance Analyst II will play a key role in shaping the Quality team and compliance efforts at Revalia Bio to ensure that all processes, documentation, and product development activities comply with ISO13485, 21 CFR 820, 21 CFR 11, and other regulatory standards. This is an excellent opportunity for someone who is detail-oriented, self-governing, and eager to grow in the field of quality assurance, particularly within the medical device industry. The right candidate will be willing to build and shape quality processes around a shared vision and execute the implementation of robust quality controls in partnership with key stakeholders across the organization.
This is a contract position working 10 - 15 hours per week with the potential to convert to full-time.
Culture Requirements
- Role model Revalia Bio's Company Values of world class collaboration, cultivating deep trust, relentless adaptability, and to persevere with uncommon grit.
- Display high levels of personal integrity and be able to express opinions or concerns directly and without triangulation, demonstrating honesty, openness, and a positive outlook at all times.
- Seek to promote collaboration and be curious (and not judgmental) about opposing opinions.
- Ability to adapt to changing business needs or to personal development opportunities. Able to fully embrace feedback and training to continuously improve performance and relationships.
- Display determination and perseverance to problem solve, create, innovate, and develop.
- Demonstrate commitment to own personal growth and development. Be "all -in" when participating in Company activities and programs related to personal and professional development and training.
- Commitment to the growth and development of their team including participation in 360 reviews where requested.
Soft Skill Requirements
- Extremely strong attention to detail and time management skills.
- Extremely strong emotional intelligence, communication, collaboration and influence skills.
- A curious and solution-oriented nature with the ability to identify, analyze, and solve problems creatively
Technical Skill Requirements
- Familiarity with FDA 21 CFR 820, 21 CFR 11, ISO 13485, and regulatory submission processes is a plus.
- Knowledge of GLP, GXP, and/or GMP guidelines is a plus.
- Basic understanding of medical device development, risk management, and quality systems.
- General familiarity with document control systems and quality management software is expected.
Responsibilities
- Assist in the creation, revision, and management of quality documentation, including validation/qualification protocols and test scripts, design control documentation, Standard Operating Procedures (SOPs), work instructions, and forms to ensure compliance with internal policies and regulatory requirements.
- Ensure compliance with FDA regulations (21 CFR 820, 21 CFR 11), ISO 13485, and other applicable standards. Participate in maintaining records for audits and inspections.
- Support the implementation and maintenance of the company's QMS and eQMS, ensuring processes adhere to regulatory and quality standards, and electronic records are maintained and up-to-date.
- Assist in identifying, investigating, and documenting non-conformances, including root cause analysis, corrective and preventive actions (CAPA), and tracking the resolution of issues.
- Oversee the change management process for product design, manufacturing processes, and documentation to ensure traceability and regulatory compliance. Assist in the change management process for computerized systems and other software systems.
- Work closely with the R&D team to ensure that all design and development activities comply with design control requirements under 21 CFR 820.30.
- Support the evaluation and qualification of suppliers, particularly those providing components for potential 510(k) devices.
- Participate in product testing and verification activities, ensuring proper documentation and reporting of test results.
- Assist in the risk analysis process (e.g., FMEA) for medical devices and support the documentation and implementation of risk mitigation strategies.
- Assist in organizing and documenting internal training programs related to quality and regulatory compliance.
- Assist in conducting internal quality audits to assess compliance with SOPs and regulatory standards and help prepare for external audits.
- Support the team in post-market surveillance activities, including monitoring product performance and handling customer complaints and feedback.
Qualifications
Preferred: M.S. Degree in life science, biomedical engineering, quality assurance, or related field and 3+ years of experience in quality assurance, preferably within the medical device, biotech, or pharmaceutical industries.
Accepted: B.S. Degree in life science, biomedical engineering, quality assurance, or related field and 2+ years of experience in quality assurance, preferably within the medical device, biotech, or pharmaceutical industries. Internship experience or academic projects related to quality control or regulatory compliance may be considered.
Compensation and Diversity Commitment
The range for this role is $65-$80 per hour. Revalia Bio acknowledges and celebrates the diversity of our workforce, is dedicated to creating an equitable workplace, is committed to fostering an inclusive environment, and aims to create a workplace culture where every individual feels a sense of belonging. We are an equal opportunity employer and do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, gender, gender identity or expression, age, disability, or genetic makeup. For individuals with disabilities who would like to request an accommodation please email .