Quality Assurance Engineer

1 month ago

San Diego, United States REVA Medical Full time

Summary of Essential Duties and Responsibilities

Provides technical engineering support to new and existing product development and sustaining engineering teams. Applies knowledge of test method principles and quality engineering techniques to development efforts as a member of one or more cross-functional development team(s). Ensures products are tested in accordance with applicable industry standards, regulatory requirements, and customer requirements.

Provides regulatory support for current product operations and manufacturing.

Education and/or Experience

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

A minimum of 4 plus 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.

Proven record of providing Quality Assurance input to compliance of regulated products.

Demonstrated ability to work at all stages of product development.

Thorough understanding of the CFR, FDA/ICH guidelines and cGMP's as they pertain to Medical Devices and combination products

Demonstrated ability to work independently and produce professional work products.

Strong written and verbal communication skills

Experience participating on project teams.

Experience implementing an eQMS is highly desired.

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 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 cosmetic and cosmetic/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.

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