General Purpose: Responsible for providing support and executing investigations for complaints regarding medical or pharmaceutical products. Manages, documents, and reports quality events while contributing to regulatory compliance, continuous improvement, and service excellence, collaborating with internal and external teams and fostering an inclusive environment.

Main Responsibilities:

• Investigate, analyze, and follow up on product complaints, performing functional, visual, or dimensional testing as needed.
• Document all relevant information (product history, device records, risk documentation, labeling), ensuring compliance with good laboratory, manufacturing, and documentation practices.
• Determine root cause of complaints and conduct basic statistical analysis, reporting results to teams.
• Identify potentially reportable events and escalate as appropriate (to PMS Manager, Clinical Specialist, regulatory authorities).
• Support the management of CAPAs, NCEPs, OOTs, and other improvement and compliance activities.
• Participate in continuous improvement and innovation projects related to complaint investigation processes.
• Use documentation systems (QMS, databases, tracking sheets) to monitor, track, and report results.
• Train peers in processes/products when required.
• Collaborate with product integration and transfers from/to other sites.
• Assist in environmental health and safety (EHS), ensuring proper calibration, preventive maintenance, and control of laboratory equipment.
• Manage complaint investigations closure effectively and promptly.
• Support communication with third parties (OEMs, Contract Manufacturers, internal clients, functional areas).

Formal requirements:

• University degree (engineering, science, technology, health) or equivalent experience.
• 2+ years of experience in similar positions (regulated industry, medical devices, laboratory, quality).
• Knowledge of FDA regulations, ISO 13485/14947, EU MDD/MDR, good laboratory and manufacturing practices, and risk analysis tools (FMEA, FTA).
• Skills in technical documentation, data analysis, basic statistics, problem solving, and effective communication.
• Experience with complaint management and documentation systems (QMS, databases, spreadsheets).
• Intermediate to advanced English (B2+)

Soft Skills:

• Results-oriented, planning, organizational agility.
• Active listening, decision making, and problem solving.
• Ability to collaborate with cross-functional teams and manage multiple priorities.
• Commitment to diversity, equity, and inclusion, and corporate policies.

Added Values:

• Customer-oriented and focused on service excellence.
• Active participation in continuous improvement, innovation, and compliance initiatives.
• Compliance with legal, corporate, EHS standards, and internal diversity and equality policies.

At Abb Vie, we are committed to cultivating a workplace culture that promotes inclusion, diversity, and personal growth. We recognize that our collective success is based on the individual well-being of our employees, which is why we have designed a benefits package that considers every aspect of their lives.

• Enhanced Health and Wellness Coverage: Our administrative staff enjoys comprehensive medical and dental insurance, ensuring peace of mind for you and your loved ones.
• Extended Vacation: We believe in the balance between work and personal life for our administrative team. That’s why we offer additional vacation days, beyond legal requirements.
• Flexible Hybrid Work Model: For eligible positions within our administrative staff, we have adopted a hybrid work scheme allowing the convenience of working from home two days a week.
• Life Insurance: Secure your family’s future with our life insurance policy.
• Employee Assistance Program (EAP): Access professional support with our comprehensive EAP, offering psychological, legal, and financial counseling.
• On-Site Health Services: Benefit from the convenience of having a company doctor and physical therapy services, demonstrating our commitment to your health and well-being.
• Community and Social Engagement: Make a difference with a paid volunteer day, allowing you to contribute to the community during company working hours.
• Special Leave Benefits: Celebrate your life achievements with extra leave days for marriage and enjoy your birthday with a day off.
• Employee Stock Purchase Plan: Participate in our company's success by purchasing shares at a special price exclusive to employees.
• Transportation and Meals subsidized.
• Solidary Association: Join a community focused on mutual help and enjoy the benefits that come with being a member.

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Abb Vie's mission is to discover and produce innovative medicines that provide solutions for serious health problems of today while addressing the medical challenges of tomorrow. We strive to transform people's lives in several key therapeutic areas such as immunology, oncology, neuroscience, ophthalmology, virology, in addition to products and services from our Allergan Aesthetics portfolio. We are proud to be a Great Place to Work company.