Job Description:

The successful candidate will significantly influence the company's compliance with quality system regulations and standards, particularly in evidence-based and scientifically-proven product areas such as product inspection, engineering design controls, and design change controls.Please double check you have the right level of experience and qualifications by reading the full overview of this opportunity below.ResponsibilitiesInvestigating and supporting individual customer product complaints by summarizing and reporting results.Ensuring compliance with the Quality System through policy establishment and controlled documents.Conducting Process Validations, including necessary risk management activities.Managing nonconforming material and supporting daily Material Review Board (MRB) activities.Providing support to New Product Development (NPD) teams regarding 21 CFR Part 820, Part 1271, and associated EU/Canadian standards.Establishing, documenting, and maintaining the company's document control system, including change control and record-keeping.Assisting Research & Development with reviewing and approving design inputs.Overseeing regulatory and manufacturing standard reviews to ensure State of the Art compliance.Documenting, releasing, and communicating changes to company supplier quality assurance policies and procedures.Qualifications2 years in FDA-regulated environment with technical specs and documentation.Proficient in Microsoft Windows and Office applications.Excellent reading, writing, and verbal communication skills.Knowledge of regulatory medical device and international quality standards desired.Professional interaction with colleagues and suppliers.Experience with Electronic Quality Management System software (e.g., ETQ Reliance) desired.Bachelor's degree preferred or equivalent experience.ASQ Certified Quality Engineer certification preferred.