Quality Engineer - Systems

Location: Hazelwood

Description

Position Summary

Ensures, through global and local Product Development Process procedures and efforts, that System/Instrument 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 and identified applicable conformity standards.

Participates and provides guidance to quality improvement teams on tools, techniques and management systems for quality assurance, compliance, and continuous quality improvement/best practice, including those based on identification of systemic weaknesses in the product development process.

Primary Duties

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, reviewing and approving design control deliverables and assuring the Design History File (DHF) is accurate and complete.

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.

Communicate/liaise and assess the impact between product development projects/efforts (i.e. software, reagent, disposable), as necessary, to achieve successful full-System development completion/launch.

Contribute to 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.

Develop and execute design control training programs (e.g. design change control, risk analysis, etc. as requested).

Prepare for 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.

Participate in site CAPA activities, including investigation, effectiveness, and root cause analysis, etc.

Coordinate implementation of corrective actions and preventive measures, as needed.

Function as QA subject matter expert for cross-functional development team related practices.

From a product system development perspective; identify potential or experienced systemic weaknesses in the product development process and develop and recommend relevant continuous quality improvement/best practice, 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.

Perform all work in compliance with company quality procedures and standards.

Perform other duties as assigned.

Qualifications

Required Education, Training, and Experience

Bachelor degree in an Engineering, Life Sciences or related field with 5 years experience of R&D Quality Assurance of Medical Devices or IVD's

OR

9+ years experience of R&D Quality Assurance of Medical Devices or IVD's in lieu of degree

Demonstrated competence in the selection and use of Quality Engineering tools, techniques, and processes as pertaining to In Vitro Diagnostic System development as well as the ability to identify development process weaknesses and/or develop and recommend process improvements/best-practice.

Expert knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, IVDR, QSR, MDSAP, etc.).

Preferred Education, Training, and Experience

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.

Knowledge,…