R&D Staff Quality Engineer

Description

The Company

The world is facing a medical crisis, bacteria are increasingly evolving resistance to even our strongest antibiotics. The problem is already very real and immediate; for example, bloodstream infection leading to sepsis is now responsible for more than half of all deaths in hospitals and is the most expensive condition treated in hospitals. Sepsis mortality rate increases >6% every hour without effective antibiotic treatment. Yet, despite the life and death urgency, and healthcare cost impacts, current methodologies require 3 days to determine the correct antibiotic.

Specific Diagnostics, a bioMerieux company, has developed a breakthrough solution to rapidly determine the effective antibiotic treatment for bloodstream and other acute infections. Used for bloodstream infection Specific’s solution provides results 2 days sooner (1 day vs 3 days).

We offer an opportunity to join us at an inflection point in our commercial growth, with our first commercial product being released new venture capital funding and recognition from major customers and government agencies fueling an expansion of our staff.

The Job

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.  Ensures, through global and

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

Primary Duties

1. Contribute in the documentation of quality systems and programs in the area of training, change management, validation, design controls, including product verification and validation, CAPA for relevant design issues, documentation control considerations, etc. to ensure compliance with FDA and regulatory requirements.

1. Quality Engineering Support for Design Control Process – Design, approve, and implement development effort/project planning as needed, review and approve project documentation as requested. Represent the R&D Quality function by participating in design reviews, developing quality engineering deliverables and assuring Design History File (DHF) is updated and reviewed for accuracy/ completeness when necessary. Provide guidance / support to program directors, project managers, product development teams, R&D, and Product Validation functions in regard to application of design controls, scalability, and related development process practices and improvements.
2. Develop and execute design control training programs (e.g. design change control, risk analysis, etc. as requested).

1. Prepare for and and support regulatory and agency inspections/audits (ISO/MDSAP/etc.), investigations, and inquiries regarding the control and assessment of product design quality. Support corporate/internal design control audits.

1. Participate in site CAPA activities, including investigation, effectiveness, and root cause analysis, etc. Coordinate implementation of corrective actions and preventive measures, as needed.
2. Function as QA subject matter expert for cross-functional development team related practices: facilitate risk management activities, provide guidance for strategy and content of requirements and specifications. Provide strategies and approvals for verification methodologies, configuration management, validation and regression testing approaches.

Knowledge, Skills and Experience

1. Requires a minimum of eight (8) years increasingly responsible experience in a related industry regulated by FDA and/or ISO.  Microbiology experience preferred.  
2. Requires demonstrated competence in the selection and use of Quality Engineering tools, techniques, and processes.
3. Must possess expert knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, IVDR, QSR, MDSAP, etc.).
4. Project or Team Leadership experience strongly preferred.  Requires effective written and oral communication skills to interact across all levels of the organization.
5. Must have advanced working knowledge of Microsoft Office Package (Word, Excel, etc.).
6. One or more of the following certifications is strongly 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 Black Belt.
7. Masters Degree in relevant discipline is highly desired.

Impact/Management Scope

This position is responsible to develop quality programs to facilitate continual improvement actions.  Also responsible for assuring product quality and reliability during all phases of product life cycle.