Quality Engineer

Description The Quality Engineer supports and executes design control, risk management, and validation activities for Class II hematology reagents and controls. This role in ensuring products and processes meet regulatory, quality, and performance requirements. The position works cross-functionally with R&D, Manufacturing, and Quality teams to support compliant product development, process validation, and lifecycle maintenance. Quality measurement trending, procedure/document review, and auditing. The position is expected to take ownership of defined design control documentation and reviews , supporting accelerated project timelines while maintaining regulatory compliance. Job Responsibilities

• Maintain Design History Files (DHF) for reagent and control products
• Actively support development and review of: Design inputs and outputs
• Verification and validation protocols/reports
• Ensure traceability: User needs → design inputs → outputs → V&V
• Participate and host in design reviews and document meeting outputs and risk reviews.
• Support risk management activities in accordance with

ISO 14971

• Review and approve (within defined scope) Validation and Qualification protocols, reports and activities
• Support validation of: Mixing tanks, filling equipment, and storage systems and Laboratory test methods (e.g., stability, bioburden, performance)
• Review document validation data in accordance with approved protocols
• Support investigations related to: Nonconformances and Out-of-specification (OOS) results
• Lead in root cause analysis and corrective actions (CAPA)
• Work with Manufacturing to ensure: Proper implementation of SOPs Process consistency for reagent production
• Review of Quality Documentation including Change Orders and production records. Labeling accuracy (including lot-specific data) and Material specifications
• Ensure compliance with applicable regulatory expectations for in vitro diagnostics (IVDs)
• Ensure documentation aligns with:

FDA 21 CFR

Part 820 and

ISO 13485

Support internal and external audits by preparing documentation and responding to requests

• Identify opportunities to improve: Validation processes, Documentation clarity and compliance
• Support implementation with Quality projects and Objectives
• Support Change Order process, review and approvals.
• Participate in quality system improvements and standardization efforts
• Support internal and external audit programs
• Reviews, analyzes, and reports on quality discrepancies related to process and manufacturing
• Performs quality and regulatory tasks assigned and ensure cross training
• Participates on project teams as assigned by management.
• Performs other related duties required or as directed that are related to position Preferred Qualifications GMP or regulated environments Understands and interprets regulatory, FDA, ISO and other industry standards.

Develop team culture to provide an optimum environment for employees' growth and contribution. Operates with appreciable latitude for actions and/or decisions on day-to-day activities. However, is expected to seek guidance on novel or controversial problems that may impact the business significantly. Demonstrated mindset of Quality as a partner and enabler to R&D and Operations Pre-requisites/Job Experience

• Bachelors Degree in life sciences, enginerring field, or an alternative Bachelors degree program with certificate
• 2-5 years of experience in: Medical devices, diagnostics, biotech, or pharmaceutical environment. An equivalent combination of education/training and experience will be considered.
• Project experience in: Validation, lab testing, or quality systems preferred
• Self-starter with ability to manage workload with minimal direction/supervision.
• Proficient in Microsoft Office Suite
• Understanding and working knowledge of QSR/ISO regulations.
• Able to communicate both orally and in written form clearly and concisely throughout all levels within the company.
• Strong interpersonal skills.
• Ability to work within a team environment, utilize collaborative techniques, and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
• Ability to deliver, meet deadlines, and is result orientated.
• Strong critical thinking/reasoning and problem-solving skills required to address issues in the most efficient and effective manner.
• Able to multi-task and support/prioritize projects, adapt to shifting priorities, and able to resolve problems / conflicts.
• Strong attention to detail
• Good written and verbal communication
• Ability to follow procedures while applying quality requirements pragmatically to support business needs and learn quickly
• Team-oriented with willingness to ask questions, challenge constructively and seek guidance Physical Requirements Must be able to lift a minimum of 25 pounds.
• Work may occasionally involve processes that require following safety precautions and use of personal protective equipment

Job Type:

Full-time Pay:

$70,000.00 - $80,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Life insurance Paid time off Vision insurance Application Question(s): How many years of project experience in validation?

Education:

Bachelor's (Preferred)

Experience:

Medical Device:

2 years (Preferred)

Work Location:

In person