Role Description
We are seeking a versatile and dedicated Quality Engineer with expertise in software quality, regulatory compliance and sustaining engineering in the medical device and health tech industries. This unique role will ensure the highest standards of quality and reliability in our products, while also supporting regulatory requirements and sustaining engineering efforts. This position is a hybrid role based in San Diego. This position will also be required to commute to contract manufacturers as needed.
Responsibilities and Duties:
- Develop and maintain Zerigo Health’s Quality Systems.
- Define, specify, and implement quality standards and procedures.
- Responsible for supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and Good Manufacturing Practices.
- Track supplier performance relative to quality and delivery issues.
- Review and modifies on appropriates device assembly plans including quality checks.
- Modifies methodologies and procedures, ensuring continuous improvement of desired outcomes.
- Support the Control of Nonconforming Product and CAPA processes by performing investigations and root cause analysis, determining action plans, and driving the actions to closure.
- Prepare corrective action responses, problem solving for permanent corrective actions, and lead problem solving activities.
- Create regulatory files such as 510K, maintenance of registrations including renewals, device listings, site registrations, supplements for change controls.
- Provide regulatory requirements and impact of regulations on changes to product.
- Submitting required data, reports and maintaining licenses with regulatory bodies and agencies.
- Provide input and run the management review process and ACHC processes.
- Provide regular progress reports and quality metrics to management and cross-functional stakeholders, including developing resolutions as needed to improve metrics achievement.
- Perform root cause analyses, resolve and implement product fixes, modifications, and design enhancements.
- Track, troubleshoot, and identify the root cause for product issues.
- Lead production yield improvements, reduce product variability, and drive product cost reduction.
- Develop automated test capabilities to support product design verification and long-term testing.
- Provide engineering support for component obsolescence issues.
- Provide engineering support for product compliance (REACH, ROHS, CE, etc.).
- Support the design and testing of new products.
- Responsible for the transfer of new products from engineering to manufacturing.
- Provide full documentation of design including, BOM, drawings, and procedures.
- Partner with cross-functional teams assigned to process improvement projects.
- Responsible for process validation.
- Be the manufacturing process technical expert who can provide engineering knowledge and oversight to resolve manufacturing, design and quality-related problems with existing products.
- Review existing product design, identify weaknesses, propose, implement and monitor effectiveness of improvements.
- Planning, developing and implementing firmware.
- Maintaining stable firmware.
- Performing code reviews.
- Writing and maintaining firmware documentation.
- Testing firmware releases.
- May perform other duties as required.
- May required some travel as needed (5%).
Skills & Experience:
Education and Experience
- Bachelor's degree in engineering or another technical field of study.
- Excellent written and verbal communication skills and the ability to interact with members across the organization.
- A minimum of 5 -10 years of successful work experience in the medical device field
- Knowledgeable of FDA, QSR, cGMP, ACHC.
- Extensive knowledge of Solid works.
- Knowledge of device standards such as IPC-610, ISO 13485, IEC-60601-1.
- Experience in program or project leadership and the associated communication, presentation, team facilitation, and influence management skills.
- Ability to interpret and understand CAD modeling, drawings and machine design with experience in design analyses. Experience with SolidWorks is a plus.
- Experience in vendor auditing.
- Experience with FDA and regulatory processes.
- Experience with design and Process Failure Mode and Effects Analysis (PFMEA).
- Knowledge, understanding and implementation experience with medical device quality systems, manufacturing operations, supplier quality, and regulatory requirements.
- Ability to present, organize and convey problems or issues.
- Ability to take initiative and make sound judgements based on data.
- Possess critical thinking and problem-solving skills.
- Ability to work independently and in teams.
- Ability to take initiative and work with infrequent supervision.
- Experience in developing and debugging firmware.
- Proficiency in programming languages.
Nice to Have:
- Experience in Altum.
- Experience in mobile app or web-based systems design, development, verification, and documentation.
- Experience with mobile apps deployment and post launch maintenance.
- Experience working with communications protocol design, definition and documentation.
Zerigo Health is an equal opportunity employer and is committed to diversity and inclusivity in the workplace. We do not discriminate on the basis of race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
