Quality Engineer III

Description

Position Summary:

Ensures, through global and local Product Development Process procedures and efforts, that Molecular products are developed, tested and transferred to manufacturing according to established procedures that will assure that they meet all quality requirements.

Responsible for the implementation and maintenance of effective Quality Systems in accordance with FDA Quality Systems Regulation, ISO 9001, ISO 13485 and other applicable country specific regulations.

Participates and provides guidance to quality improvement teams on tools, techniques and management systems for quality assurance, compliance, and continuous quality improvement.

Qualifications:

Training & Education:

Required- Bachelor's Degree in science or engineering discipline. Master's degree in a scientific discipline is preferred or minimum (5) years of relevant Health Industry (IVD, MD, Biotech or Pharma) experience within R&D, Product Development, Design Controls, Technical support, QE/QA/QC or Regulatory Affairs required.

Knowledge in biology, and specially in molecular biology is preferred, but not required.

Must have exposure to and knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO 13485, 21CFR820, EN 62366, IEC 62304, ISO14971, 21CFR11, MDR 2017/746 and CLSI)

Requires effective written and oral communication skills to interact across all levels of the organization.

Must have experience in and knowledge of Microsoft Office Package (Word, Excel, etc.).

One or more of the following certifications is desired for this role: Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), Certified Reliability Engineering (CRE), Certified Biomedical Auditor (BCA), or Six Sigma Green / Black Belt.

Experience:

Minimum 5-years previous on-the-job experience requiring professional communication and interactions utilizing skills outlined below

Previous experience in anEngineering, Scientific or Investigative role is required.

Demonstrated competence in the selection and use of Quality Engineering tools, techniques, and processes is preferred.

Experience in Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system with involvement in Design controls is preferred.

Experience and/or education in biology, and specifically in molecular biology is preferred, but not required.

Master's degree in relevant discipline is highly desired.

Knowledge, Skills, & Abilities:

Competent understanding of Design controls

Technical writing skills

Writing procedures, flowcharting

Ability to collaborate cross-functionally

Application of Quality Risk Management principles

Attention to detail (e.g. document reviews, design reviews).

High level of written and verbal communications skills

Ability to communicate with R&D Engineering and perform risk analysis as instructed.

Wisdom to seek help when needed.

Proficiency in MS Office tools, including Outlook, Word, and Excel