Quality Assurance Engineer

Summary of Essential Duties and Responsibilities

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 team(s). Develops and implements procedures and processes to ensure products are developed and tested in accordance with applicable industry standards, regulatory requirements, and customer requirements.

Provides quality engineering support for regulatory submissions.

Duties / Responsibilities

Follows the procedures and instructions in the REVA Medical Quality System in the execution of all relevant tasks and responsibilities.

Develop and implement quality test procedures, including the design of tests, testing mechanisms and test equipment.

Develop and execute test 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.

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 in accordance with ISO14971

Reviews production data and performs statistical analysis to track metrics and to analyze trends.

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).

Assist in "troubleshooting" problems related to the manufacture, test, validation and documentation. Also represents quality assurance function in project team meetings.

Participates in internal / supplier audits and interacts with external regulatory inspectors as subject matter expert.

Provides quality engineering support to support regulatory submissions and requests from external regulatory bodies

Participates in and manages special projects and other duties as assigned.

Education and / or Experience

At minimum, bachelor's degree in technical discipline, preferably engineering or science. MS or advanced degree desirable.

A minimum of 4 plus years' experience in Medical Device or Pharmaceutical Quality Engineering, 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 work responsibilities listed above.

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.

Required Knowledge / Skills

Knowledge of global combination drug / device product regulations including The Food Drug and Cosmetic Act (FD&C), Good Manufacturing Practices (GMP's), EUMDR, and ISO13485.

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 related to assigned duties.

Thorough familiarity and ability to work with office automation programs and corporate database tools.

Communicates effectively, both orally and in writing. Demonstrates excellent interpersonal skills with personnel at all levels and exhibits a high degree of initiative and motivation.

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 occasionally.