Quality Assurance Engineer

About the role

Provides technical engineering support to new and existing product development and sustaining engineering teams. Applies knowledge of manufacturing principles and quality engineering techniques to development efforts as a member of one or more cross-functional development teams.

Responsibilities

• Follows the procedures and instructions in the REVA Medical Quality System in the execution of all relevant tasks and responsibilities.
• Develops and implements quality test procedures, including the design of tests, testing mechanisms, and test equipment.
• Develops and executes test equipment IQ/OQ/PQ protocols and reports.
• Conducts test method qualifications and validations.
• Develops gauge reliability and repeatability studies for test and production-related equipment.
• Develops equipment calibration procedures.
• Develops 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.
• Maintains a working relationship with suppliers to ensure resolution of supplier-critical issues and investigations, including supplier visits to technically assist in issue resolution.
• Ensures that all corrective/preventive measures meet acceptable reliability standards and that documentation is compliant with requirements.
• Participates in customer product complaint analyses, evaluation, and investigation.
• Performs investigational activities including evaluation of returned products and complaint trending analysis.
• Participates in updating, maintaining, and approving risk analysis/risk management documentation in accordance with ISO14971.
• Reviews production data and performs statistical analysis to track metrics and analyze trends.
• Reviews and approves assigned controlled documents (e.g., work instructions, quality specifications, engineering specifications, procedures, and validation protocols/reports).
• Assists in troubleshooting problems related to manufacture, test, validation, and documentation, and represents the quality assurance function in project team meetings.
• Participates in internal/supplier audits and interacts with external regulatory inspectors as a subject matter expert.
• Provides quality engineering support for regulatory submissions and requests from external regulatory bodies.
• Participates in and manages special projects and other duties as assigned.

Requirements

• At minimum, a bachelor's degree in a technical discipline, preferably engineering or science; MS or advanced degree desirable.
• A minimum of 4+ years' experience in Medical Device or Pharmaceutical Quality Engineering, or a master's degree in a scientific discipline with at least 2 years' experience in Medical Device or Pharmaceutical Quality Assurance/Engineering, or a Doctorate in a scientific discipline directly relevant to Quality Assurance or Quality Engineering.
• Demonstrated ability to work independently and produce professional work products.
• Strong written and verbal communication skills.
• Experience participating on project teams.
• Experience in related areas, including R&D or manufacturing, may also be applicable if experience includes the listed responsibilities.
• Strong work ethic and demonstrated ability to deliver assignments on time.
• Experience implementing an eQMS is highly desired.
• Experience working with Drug/Device Combination devices is highly desired.
• Experience working with and/or validating analytical equipment for polymer manufacturing, such as HPLC, GPC, and GCMS, is highly desired.

Skills

• Knowledge of global combination drug/device product regulations including The Food Drug and Cosmetic Act (FD&C), Good Manufacturing Practices (GMPs), EUMDR, and ISO13485.
• Understanding of quality system regulations, device classification, medical device submission and registration requirements, labeling and advertising requirements and restrictions, MDR reporting, recall procedures, and FDA and International regulations.
• Thorough familiarity and ability to work with office automation programs and corporate database tools.
• Effective communication, both orally and in writing.
• Excellent interpersonal skills with personnel at all levels and a high degree of initiative and motivation.

Physical Demands

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.

• Frequently required to sit or stand for prolonged periods, often in front of a computer.
• Must be able to travel occasionally.