Senior Quality Assurance Specialist at Abbott

Porto, Porto, Portugal

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Healthcare, TechnologyIndustries

Requirements

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
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

Responsibilities

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
Maintain and improve a certified quality management system (ISO9001, ISO27001, etc.), 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
Document, monitor, and track quality data and metrics
Escalate non-standard outputs and risks appropriately
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

Skills

Key technologies and capabilities for this role

Quality AssuranceISO9001ISO27001Design ReviewsRisk AssessmentsVerificationValidationCAPADocument ControlInternal AuditsPost-Market SurveillanceQMS

Questions & Answers

Common questions about this position

What education and experience are required for this Senior Quality Assurance Specialist role?

An Associate’s degree in engineering, quality assurance, or a related technical field is required, along with a minimum of 3+ years of experience in quality assurance or quality control, preferably in product development, regulated environments, non-medical products, or digital health.

What key skills are needed for this position?

Candidates need a strong understanding of quality assurance principles across the product lifecycle, ability to lead design reviews, risk assessments, and verification/validation activities, experience with document control, CAPA management, and internal audits, plus strong organizational, communication, and problem-solving skills.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What experience makes a candidate stand out for this Senior QA Specialist position?

Experience with ISO 9001 and ISO 27001 quality systems, familiarity with agile development, design control, risk management, and post-market surveillance processes, especially in regulated environments or digital health, will make a strong candidate.

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

Land your dream remote job 3x faster with AI

Try Jobo Free