bioMérieux · 3 hours ago
Quality Engineer I
Philadelphia, PA
Full-time
Onsite
Entry Level
$78K/yr - $99K/yr
2+ years expbioMérieux is a global leader in the field of in vitro diagnostics. The Quality Engineer will manage quality processes during product development and throughout the product lifecycle, ensuring compliance with international and customer requirements while supporting continuous improvement initiatives.
Biotechnology
Responsibilities
Monitor a product portfolio intended to food and/or pharmaceutical industrial diagnostic (reagents, instruments, software; microbiology, molecular biology, immunology); as such, you will be: Member of the project teams for developing or modifying these products
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 the organization 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 in compliance with company quality procedures and standards
Qualification
Required
Bachelors degree in a Scientific field required
2 years' experience in Quality or Research and Development including experience 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 meet competing deadlines, requiring careful prioritization and time management to ensure all tasks are completed on time
Understand complex 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 proactive communication to navigate situations with limited details
Informing others by sharing clear, timely information to ensure alignment
Functional skills including critical thinking, adaptability, time management, communication, 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 and communication when working across teams to achieve shared objectives
Ability to cooperate with others at all levels including leadership
Consistently uphold and reflects the core ethical principles and values that bioMérieux promotes
Preferred
Master's degree preferred
Industry experience preferred
Quality job and design control for the development of reagents and/or instruments experience is preferred
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
Company
bioMérieux
A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics.
10001+ employees
H1B Sponsorship
bioMérieux has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (2)
2022 (1)
Funding
Current Stage
Late StageLeadership Team
Jana Inman
CFO Global R&D
Aaron Ford
Talent Acquisition Partner II
Recent News
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