Title : Design Quality (specialist)

JD :

Represent Design Quality Engineering in medical device lifecycle management by engaging with cross-functional partners in system and product continuous improvement projects.

Review modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.

Review risk management documents and conduct a change impact assessment with focus on product design for every change request that pertains to modifying released products.

Perform statistical analysis of data generated including but not limited to: Process capability, Cpk, Ppk, Gauge R&R, ANOVA, Sample Size determination and variable/attribute data analysis against predetermined acceptance criteria.

Technical problem solving, compiles data and prepares reports on findings, to identify trends, proposes corrective action as needed. \ Mentor junior quality engineers in providing quality engineering support for their medical device products Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations, EU MDR and inhouse Standards.

Qualification:

Experience in leading process improvement methodologies (e.g., Lean, Hoshin or 6-sigma).

Good understanding of the Quality System Regulations (ISO 9001, ISO 13485, 21 CFR Part 803, 806 & 820) and knowledge of medical device process requirements Master's degree in science, engineering, or a related field. PMP Certification preferred.