Senior Quality Assurance Specialist

     

JOB DESCRIPTION:

Job Purpose:

This position is responsible for the implementation and management of the Quality Assurance program for the Indexor product, a non-medical device. The role includes oversight of design and development quality processes, post-market support, and continuous improvement initiatives. The Senior QA Specialist ensures that product quality and information security standards meet or exceed internal and external requirements and maintains the standard of excellence established by the Core Dx division.

Major Accountabilities

Lead quality assurance efforts during design and development phases, including design reviews, risk assessments, and verification/validation activities. Collaborate with engineering, product management, and IT teams to ensure quality and security requirements are embedded in product specifications and development workflows. Ensure quality planning and control measures are integrated into product development and change management processes.

Support post-market surveillance and customer feedback analysis to drive product improvements and ensure continued compliance.

Oversee document control, CAPA management, and internal audits related to both product quality and information security, including maintenance

Maintain and improve a certified quality management system (ISO9001, ISO27001, etc) as needed. Ensuring QMS alignment with internal policies and external standards. Facilitate external audits and regulatory inspections, ensuring readiness and effective response to findings.

Liaise with suppliers and service providers to ensure quality and security requirements are met throughout the supply chain.

Required Education, Training, & Experience

• Associate’s degree in engineering, quality assurance, or a related technical field.
• Minimum 3+ years of experience in quality assurance or quality control, preferably in product development, regulated environments, non-medical products, or digital health.
• Experience with ISO 9001 and ISO 27001 quality systems preferred.
• Familiarity with agile development, design control, risk management, and post-market surveillance processes.

Skills Required

• Strong understanding of quality assurance principles across the product lifecycle.
• Ability to lead and coordinate design reviews, risk assessments, and verification/validation activities.
• Experience with document control, CAPA management, and internal audits.
• Ability to work independently and collaboratively with cross-functional teams including engineering, product management, IT, and suppliers.
• Strong organizational and documentation skills to support QMS compliance.
• Effective communication and problem-solving skills.

Ability to prioritize tasks and manage multiple quality initiatives under pressure

Duties

• Ensure all work meets or exceeds applicable standards and specifications.
• Lead QA efforts during design and development phases, ensuring quality and security requirements are embedded in product specifications.
• Support post-market surveillance and customer feedback analysis to drive product improvements.
• Oversee document control, CAPA management, and internal audits related to product quality and information security.
• Maintain and improve certified quality management systems (e.g. ISO9001, ISO27001).
• Coordinate and support external audits and regulatory inspections.
• Liaise with suppliers and service providers to ensure quality and security requirements are met.
• Document, monitor, and track quality data and metrics.
• Escalate non-standard outputs and risks appropriately.

Additional Responsibilities

• Follow other instructions and perform related duties as requested by the Quality Director.
• Collaborate with global quality teams and technical teams in Porto, Lake County, IL, and Milan, Italy.

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:Operations Quality

     

DIVISION:CRLB Core Lab

        

LOCATION:Portugal > Porto : Rua Orlando Ribeiro, No. 78, Leça do Balio

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:Standard

     

TRAVEL:Yes, 10 % of the Time

     

MEDICAL SURVEILLANCE:Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)