Senior Quality Engineer

Basic Function

The Senior Quality Engineer position implements, maintains and enforces the internal quality management system to meet ISO standards and FDA quality system regulations.

This position works closely with development and manufacturing to establish/ensure compliance with the quality system throughout the development cycle. This position develops and implements inspection/validation processes necessary to verify products meet requirements as well as interact closely with Regulatory Affairs personnel (internal or external) to monitor product conformance.

Responsibilities

· Ensure company's adherence to the established Quality System and GMP/ISO standards, including ongoing establishment and improvement to the quality system procedures.

· Work with Engineering, Marketing, Manufacturing and Regulatory to establish measurable, valid product requirements.

· Develop and document product, process, and equipment test plan protocols, test procedures, and test reports.

· Perform tests according to various protocol requirements.

· Lead risk management and risk analysis activities.

· Devise design verification and validation plans for products based on performance specifications and risk analysis.

· Manage transition and communicate conformance to specifications, regulations and applicable international standards.

· Aide in definition and completion of in vitro and in vivo testing including applicable animal studies.

· Lead in defining and measuring process capability, process controls, and process validation.

· Define supplier quality specifications, sampling plans, and vendor qualification per quality system.

· Assist in specifications and testing of sterilization methods.

· Mentor other engineers on good engineering and testing practices

Qualifications

· Bachelor of Science in an engineering discipline or technical field required; advanced degree preferred.

· 5+ years of experience in the medical device industry; capital equipment and/or disposable device experience desired.

· Knowledge of FDA, GMP, and ISO 13485; past experience with QSR implementation is desired.

· Advanced computer skills, including statistical/data analysis and protocol/report writing.

· Demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams.

· Strong analytical and problem solving skills, as well as a good background in the medical device development process.

· Comfortable working with and seeking optimum solutions with team members in adjacent disciplines of engineering.

· Previous start-up experience, a plus.