Quality Engineer - Systems

Description

Position SummaryEnsures, 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.

QualificationsRequired 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, Skills, and Abilities

• Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
• Written Communications – including the ability to communicate technical data in written form
• Effective verbal communication skills
• Critical thinking, using logic and reason to analyze information and make decisions in the workplace.
• Functional skills including critical thinking, adaptability, time management, communication, problem-solving and digital literacy.
• Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives
• Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel — Advanced: demonstrates deep knowledge; manages complex tasks and integrates multiple tools independently

  Working Conditions and Physical Requirements (Summarized; travel shown as percentages)

  Ability to remain in stationary position for prolonged periods — YesAbility to ascend/descend stairs, ladders, ramps — YesAbility to adjust or move objects up to 10 pounds — YesDomestic travel required: 5%International travel required: 5%Total travel: 10%

  The estimated salary range for this role is between $92,000-$136,000 This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer. 
  In addition, bioMérieux offers a competitive Total Rewards package that may include: 
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• A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options