Quality Engineer I

Biofire Diagnostics • Philadelphia, PA

26d

About The Position

The Quality Engineer in the Global Industrial Applications Pre & Post Market Quality team will be fully involved in managing quality processes during product development as well as during the product lifecycle.

Requirements

• Bachelors degree in a Scientific field required.
• 2 years' experience in Quality or Research and Development
• Including expereince in PCR, molecular biology, microbiology techniques and diagnostic product development.
• Knowledge of standards applicable to design control and to pharma and/or food field (ISO 9001, ISO 13485, ISO 14971, 21CFR820, GAMP, 21CFR11, GMPs, ISO 16140 …) and the capacity to act as  a quality auditor.
• Knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, IVDR, AFNOR etc.).
• Knowledge of the industrial domain is strongly expected (pharmaceutical, cosmetic, food industries) Experience in participation in the management of regulatory audits (i.e. ISO 9001,ISO 13485, FDA, etc.).
• Manage and meetpeting deadlines, requiring careful prioritization and time management to ensure all tasks arepleted on time.
• Understandplex information and interpret it accurately, often requiring critical thinking and analysis to grasp the full picture.
• Effectively deal with ambiguity requiring adaptability, critical thinking, and proactivemunication to navigate situations with limited details
• Informing others by sharing clear, timely information to ensure alignment.
• Functional skills including critical thinking, adaptability, time management,munication, problem-solving and digital literacy.
• Critical thinking, using logic and reason to analyze information and make decisions in the workplace
• Managing and measuring work by tracking progress, performance, and goal achievement using metrics and KPIs.
• Communicates instructions clearly and effectively
• Ability to work cross-functionally allowing for better collaboration andmunication when working across teams to achieve d objectives
• Ability to cooperate with others at all levels including leadership
• Consistently uphold and reflects the core ethical principles and values that bioMérieux promotes

Nice To Haves

• Master's degree preferred.
• Industry experience preferred.
• Quality job and design control for the development of reagents and/or instruments experience is preferred.

Responsibilities

• Member of the project teams for developing or modifying these products. The preferred contact and the guarantor of the quality processes implemented throughout the product lifecycle (such as design control, design change management, field actions management), in accordance with bioMerieux, international and customer requirements.
• Pilot and ensure that product risk management is controlled all along the product lifecycle.
• Be able to challenge and to propose alternatives on technical and strategic choices and decisions made in the projects, with regards to risk-taking on quality and business aspects; be able to escalate wisely.
• Manage theanization of Field Action Board meetings in charge of deciding on the actions to be taken in the field in the event of problems with the marketed products; as such, you will interface with GiCS (global industry customer service) representatives, manufacturing site quality manager, program directors and Industrial Applications Quality Managers.
• Be the preferred contact for other functions, on quality processes for your product ranges.
• Support the teams for audit preparation and be the preferred audit contact for quality purposes about development and field actions on your product portfolio.
• Contribute to improving the product lifecycle efficiency or any quality process required within the Industry Unit; as such, you will coordinate or contribute to continuous improvement initiatives as well for your ranges as for overall practices harmonization, interfacing with other professions.
• Perform all work inpliance withpany quality procedures and standards.

Benefits

• A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
• Company-Provided Life and Accidental Death Insurance
• Short and Long-Term Disability Insurance
• Retirement Plan including a generous non-discretionary employer contribution and employer match.
• Adoption Assistance
• Wellness Programs
• Employee Assistance Program
• Commuter Benefits
• Various voluntary benefit offerings
• Discount programs
• Parental leaves

What This Job Offers

• Career Level: Entry Level
• Number of Employees: 1,001-5,000 employees