Quality Engineer

LivaNova PLC; Mirandola; In loco; EUR 31.000 - 50.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical insurance

Pension scheme

Employee stock purchase plan

Flexible working options

Global recognition programme

Descrizione del lavoro

LivaNova PLC in Mirandola, Italy is seeking a Quality Engineer to join the Quality team and support product development, process validation, and quality improvements in a regulated medical device environment.

Responsibilities include defining product requirements, performing Design Control activities, reviewing verification/validation plans, and leading CAPA investigations to ensure compliance and patient safety. Fluency in English and cross-functional collaboration are essential.

Competenze

• Degree in Engineering, Chemistry, Biology, Physics or another scientific discipline.
• 1-3 years of experience within Quality Assurance in the Medical Device or Pharmaceutical industry.
• Experience supporting product design and development activities.
• Good understanding of Product Development Processes and Design Control principles.
• Knowledge of ISO 13485 and Quality Management Systems.
• Understanding of Good Manufacturing Practices (GMP).
• Experience with validation activities, CAPA management, nonconformance investigations, and root cause analysis is a strong advantage.
• Strong analytical and problem-solving skills with cross-functional teamwork and good communication.
• Fluent English, both written and spoken; proficient in Microsoft Office.

Mansioni

• Partner with R&D and Engineering teams to define product and process requirements.
• Support Design Control activities throughout the product development lifecycle.
• Review product verification and validation plans, protocols, and reports.
• Review process validation activities to ensure compliance with quality requirements.
• Lead investigations related to verification and validation failures.
• Establish and maintain product quality control plans and CAPA programs.
• Contribute to risk assessments and product safety evaluations when needed.
• Collaborate with suppliers and external partners on quality issues.

Conoscenze

Quality Assurance

Product Development

CAPA management

Design Control

Risk Management

Cross-functional teamwork

Analytical skills

MS Office

Formazione

Engineering, Chemistry, Biology, Physics or related

Descrizione del lavoro

As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow- because at LivaNova, we don't just treat conditions - we aspire to alter the course of lives.

Who are we looking for:

Are you passionate about quality, product development, and ensuring that healthcare products meet the highest standards of safety and compliance? We are looking for a Quality Engineer to join our Quality team and play a key role in supporting product development, process validation, and quality improvement activities within a highly regulated medical device environment. In this role, you will work closely with R&D, Manufacturing, and Quality teams, contributing to the development and maintenance of innovative medical devices while ensuring compliance with international quality and regulatory standards. This opportunity is ideal for someone with experience in Product Development, Design Control, and Quality Assurance, who enjoys solving complex quality challenges and collaborating across functions to drive continuous improvement.

Your new role:

• Partner with R&D and Engineering teams to define product and process requirements.
• Support Design Control activities throughout the product development lifecycle.
• Review product verification and validation plans, protocols, and reports.
• Review process validation activities to ensure compliance with quality requirements.
• Participate in change impact assessments and evaluate quality implications of product or process changes.
• Coordinate investigations related to verification and validation failures.
• Establish and maintain product quality control plans.
• Identify and lead quality improvement initiatives within manufacturing operations.
• Analyze nonconforming products and support disposition decisions.
• Lead root cause investigations for product and component failures identified during production or through customer complaints.
• Manage CAPA activities and analyze quality trends to identify improvement opportunities.
• Support suppliers and external manufacturing partners in addressing quality issues and nonconformities.
• Contribute to risk assessments and product safety evaluations, including Health Hazard Assessments (HHA) when required.

How you'll make an impact:

• Ensure that medical devices are developed and manufactured in compliance with regulatory and quality requirements.
• Act as the Quality representative within cross-functional product development projects.
• Support the successful launch and maintenance of products by identifying risks and quality concerns early in the process.
• Improve manufacturing quality performance through structured problem solving and continuous improvement initiatives.
• Drive investigations and corrective actions that enhance product reliability and patient safety.
• Contribute to maintaining a strong Quality Culture across the organization.

About you:

• Degree in Engineering, Chemistry, Biology, Physics, or another scientific discipline.
• 1-3 years of experience within Quality Assurance in the Medical Device or Pharmaceutical industry.
• Experience supporting product design and development activities.
• Good understanding of Product Development Processes and Design Control principles.
• Knowledge of ISO 13485 and Quality Management Systems.
• Understanding of Good Manufacturing Practices (GMP).
• Experience with validation activities, CAPA management, nonconformance investigations, and root cause analysis is considered a strong advantage.
• Strong analytical and problem-solving skills.
• Ability to work effectively in cross-functional teams.
• Good communication and stakeholder management skills.
• Fluent English, both written and spoken.
• Proficient in Microsoft Office Suite.

What you will find:

• The opportunity to work on products that directly impact patients' lives.
• Exposure to the full product development lifecycle within the medical device industry.
• A collaborative environment where Quality, R&D, and Manufacturing work closely together.
• The chance to develop expertise in Design Quality, Validation, Risk Management, CAPA, and Product Development Processes.
• Continuous learning opportunities within a highly regulated and innovation-driven industry.
• A dynamic and international environment focused on quality, compliance, and continuous improvement.
• Career growth opportunities within Quality Engineering and Product Development functions.

Location: Mirandola, Italy

WHAT WE CAN OFFER YOU:

• National Collective Bargaining Agreement: CCNL Gomma Plastica
• Level: A/C
• Base Salary range: € 31.000 – € 50.000
• Bonus: 0-5%
• Actual compensation will be determined based on relevant experience, qualifications, and internal equity considerations.

We offer a competitive benefits package including:

• Flexible working options.
• Medical insurance.
• Pension scheme.
• Employee stock purchase plan.
• Global recognition programme.
• Additional benefits (e.g. meal vouchers, flexible benefits, local bonuses) may apply depending on location.

Welcome to impact. Welcome to innovation. Welcome to your new life.

We treat our work as if lives depend on it - because they do.

As a people-oriented company, our employees around the world are fully committed to making the world a better place.

Our team's commitment to improve quality of life is the embodiment of our company Vision and Mission, making a difference every day for patients and their families.