Manager, Quality Engineer

REVA Medical, Inc.; San Diego (CA); On-site; USD 140,000 - 180,000; Full time

Job summary

REVA Medical, Inc. is seeking a Manager of Quality Engineering in San Diego to lead QA teams and drive compliance across new product development and maintenance of medical devices.

You will apply Six Sigma and DOE methods, oversee validation, CAPA, and supplier quality, and partner with regulatory affairs to ensure safety and effectiveness.

Qualifications

• Bachelor's degree in mechanical engineering, chemical engineering, biomedical engineering, or related field.
• Minimum 5–7 years medical device experience in regulated ISO/cGMP/GLP environments.
• Experience with catheters/medical devices and interventional cardiology products is helpful.
• Experience conducting complaint/CAPA investigations.
• Proven record of validation and compliance of regulated products; e-beam sterilization and software validation preferred.
• Experience with ASTM, ISO and ICH testing requirements.

Responsibilities

• Lead and mentor Quality Engineers, supporting compliance, risk remediation, and cost reduction.
• Provide leadership in problem solving, team-building, and continuous improvement.
• Oversight of QA activities to meet business goals and quality metrics for product platforms.
• Lead risk management activities for products under design authority per ISO 14971.
• Develop and execute IQ/OQ/PQ protocols, tests, and calibration procedures.
• Manage audits and interactions with regulatory inspectors; maintain controlled documents.

Skills

Quality leadership

Statistical methods

Regulatory compliance

CAPA investigations

Root cause analysis

Project management

Training others

Education

Bachelor's degree in Mechanical, Chemical, Biomedical Engineering

Job description

Duties / Responsibilities

• Manager - Quality Engineering provides direct management and technical support to the Quality Engineers supporting the REVA Medical business needs, including compliance, risk remediation, new product development, and cost reduction efforts linked to operational effectiveness
• Provide support/ mentoring/ coaching of QEs for application of technical principles, theories, concepts and quality, tools and systems; develop personnel, including dedicated succession planning and contingency management focused on win-win situations
• The position shall provide quality engineering leadership, oversight, and direction in problem-solving and team-building capabilities.
• The position shall support new product development and product maintenance through the application of Quality engineering skills for medical devices, assuring that all REVA products are designed utilizing systems which comply with applicable quality standards, industry and government standards/regulations and ultimately conform to customer expectations for safety and effectiveness.
• Develop and ensure the execution of process/equipment IQ/OQ/PQ protocols and reports. Conduct test method qualifications and validations. Develop gauge reliability and repeatability studies for test and production-related equipment. Develop equipment calibration procedures.
• Develop sampling plans for incoming materials and in-process and finished product testing based on appropriate statistical methods.
• Responsible for product-related investigations and corrective actions. Maintain a working relationship with suppliers to ensure resolution of supplier-critical issues and investigations. This may include supplier visits to technically assist in the resolution of issues and investigations. Ensure that all corrective/preventive measures meet acceptable reliability standards, and that documentation is compliant with requirements. Assure that the policies, procedures, and systems are designed and implemented to develop products which conform to established
• Lead execution of Quality activities required to meet established Business Goals and quality metric targets for product platforms and/or processes.
• Develops technical solutions and program management to address complex problems which require the regular use of technical knowledge, experience, ingenuity, and creativity
• Product expert that ensures customer requirements are met
• Assumes a leadership role in continuous improvement and development of strategies to improve Quality
• As part of the quality organization, reviews and approves assigned controlled documents (e.g. work instructions, quality specifications, engineering specifications, procedures and validations protocols/reports).
• Establish and maintain a team structure that provides excellent customer service and enables optimal use of resources
• Provide required input for Management Review
• Provide the required Quality Engineering support and promote use of statistical tools in product design and development activities
• Lead Risk Management activities for products under design authority in compliance with ISO 14971
• Provide feedback to prepare budget and adhere to approved departmental budget
• Participates in, and may provide leadership for multi-disciplinary projects
• Participate in customer product complaint analyses, evaluation and investigation. Perform investigational activities including evaluation of returned products and complaint trending analysis.
• In conjunction with product development, participates in the updating, maintaining, and approving of risk analysis/risk management documentation.
• Participates in internal/supplier audits and interact with external regulatory inspectors as subject matter expert.
• Participates in and manages special projects and other duties as assigned.

Education and/or Experience

Bachelor's degree in mechanical engineering, chemical engineering, biomedical engineering, and/or other engineering related degree

Minimum of 5-7 years medical device experience or similarly regulated ISO or cGMP/GLP environment is required.

Previous experience with catheters and/or medical devices is required. Interventional cardiology products experience is helpful.

Experience in conducting complaint/CAPA investigations

Proven record of validation and compliance of regulated products is required. E-beam sterilization validation and software validation experience is preferred.

Experience with regulatory requirements and guidance for component and product testing including ASTM, ISO and ICH.

Required Knowledge/Skills

Strong statistical background and practical application of statistical techniques (Six Sigma, DOE, etc)

Demonstrated problem solving and root cause analysis skills using risk-based approach

ASQ certification (QE, and/or Auditor) preferred

Strong attention to detail and accuracy

Ability to train others, work independently or in team setting required.

Effective presentation/communication skills, prioritization and resource management skills.

Physical Demands/Working Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to sit or stand for prolonged periods of time, frequently in front of a computer. Must be able to travel approximately 15% of the time.