Quality Engineer

Job description (Tasks/Responsibilities):

Assist in implementation of the quality system. Review new and modified product designs for quality characteristics, including manufacturability, testability, and reliability, and conformance to product requirements. Ensure that product development projects and changes to existing products are conducted in compliance with the FDA and ISO Quality System Regulations. Review and approve verification and validation test plans. Ensure verification results demonstrate compliance to medical device standards. Provide training to project teams on verification/validation statistical methods and design controls. Lead product risk assessment efforts within product teams. Review Design History Files and Technical Files for conformance to applicable requirements. Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues. Conduct internal quality system and supplier quality audits. Manage the Company Document Control System.

Skill Requirements:

Excellent communication skills, both verbal and written. Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive. Experience with test methods and standards for the design verification, and validation of medical device products. Skilled in test plan development and root cause failure analysis. Skilled in statistical methods, statistical process control, sampling plans, gauge R&R, and design of experiments. Ability to effectively work on project teams.

Education Requirements:

B.S. degree in Engineering or related science/technical field (Chemical or Mechanical Engineering preferred). ASQ CQE Certification in one or more areas (CQE, CMI, CQM, CRE, etc.) preferred. ISO 13485 Lead Auditor Certification Preferred.

Location (City/State):

Pittsburgh, PA

Company Description:

At Cohera Medical, Inc. we are committed to creating surgical devices that improve patient care and quality of life. Our philosophy is to always deliver more than expected to our customers, shareholders and employees while applying the highest standards of excellence, performance and commitment to create value. Cohera is an early stage medical device company preparing to commercialize its lead product, a surgical wound management system that will revolutionize the management and healing of surgical wounds.